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Study of DF1001 in Patients With Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04143711
Recruitment Status : Recruiting
First Posted : October 29, 2019
Last Update Posted : December 6, 2022
Sponsor:
Information provided by (Responsible Party):
Dragonfly Therapeutics

Brief Summary:
DF1001-001 is a study of a new molecule that targets natural killer (NK) cells and T-cell activation signals to specific receptors on cancer cells. The study will occur in two phases. The first phase will be a dose escalation phase, enrolling patients with various types of solid tumors that express human epidermal growth factor receptor 2 (HER2). Two combination therapy cohorts will be opened for enrollment, DF1001 + nivolumab and DF1001 + Nab paclitaxel. The second phase will include a dose expansion using the best dose selected from the first phase of the study. Multiple cohorts will be opened with eligible patients having either selected solid tumors, or solid tumors expressing high levels of HER2.

Condition or disease Intervention/treatment Phase
Solid Tumor, Adult Drug: DF1001 Drug: Nivolumab Drug: Nab paclitaxel Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 490 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II, First-In-Human, Multi-Part, Open-Label, Multiple-Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, Biological, and Clinical Activity of DF1001 in Patients With Locally Advanced or Metastatic Solid Tumors, and Expansion in Selected Indications
Actual Study Start Date : November 11, 2019
Estimated Primary Completion Date : July 2025
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Monotherapy DF1001 Dose Escalation
Dose escalation cohorts of DF1001 in sequential ascending order.
Drug: DF1001
Immunotherapy agent targeting NK cells.

Experimental: Monotherapy DF1001 Safety/PK/PD Expansion
Expansion cohorts of monotherapy DF1001 in multiple dose levels after evaluation for safety in Monotherapy Dose Escalation arm. Additional pharmacokinetic (PK) and pharmacodynamic (PD) samples included in this arm.
Drug: DF1001
Immunotherapy agent targeting NK cells.

Experimental: Monotherapy DF1001 Expansion in Urothelial Bladder Cancer
Monotherapy expansion cohort enrolling up to 20 patients with urothelial bladder cancer using the recommended phase 2 dose (RP2D) identified in the Monotherapy Dose Escalation arm.
Drug: DF1001
Immunotherapy agent targeting NK cells.

Experimental: Monotherapy DF1001 Expansion in Metastatic Breast Cancer (HER2 Low)
Monotherapy expansion cohort enrolling up to 20 patients with metastatic breast cancer with documented low expression of HER2 using the recommended phase 2 dose (RP2D) identified in the Monotherapy Dose Escalation arm.
Drug: DF1001
Immunotherapy agent targeting NK cells.

Experimental: Monotherapy DF1001 Expansion in Cancers with Erbb2 Amplification
Monotherapy expansion cohort enrolling up to 40 patients with solid tumors showing documented erbb2 amplification using the recommended phase 2 dose (RP2D) identified in the Monotherapy Dose Escalation arm.
Drug: DF1001
Immunotherapy agent targeting NK cells.

Experimental: Combination Therapy with DF1001 and Nivolumab
Combination dose escalation of DF1001 in combination with nivolumab in patients with select solid tumors.
Drug: DF1001
Immunotherapy agent targeting NK cells.

Drug: Nivolumab
Anti-PD-1 immunotherapy agent

Experimental: Combination Therapy with DF1001 and Nab-paclitaxel
Combination dose escalation of DF1001 in combination with nab-paclitaxel in patients with select solid tumors.
Drug: DF1001
Immunotherapy agent targeting NK cells.

Drug: Nab paclitaxel
A chemotherapy treatment combining paclitaxel with albumin

Experimental: Combination Therapy with DF1001 and Nivolumab Safety/PK/PD Expansion
Expansion cohort of DF1001 in combination with nivolumab after evaluation for safety in the Combination Therapy with DF1001 and nivolumab Dose Escalation arm. Additional pharmacokinetic (PK) and pharmacodynamic (PD) samples included in this arm.
Drug: DF1001
Immunotherapy agent targeting NK cells.

Drug: Nivolumab
Anti-PD-1 immunotherapy agent

Experimental: Combination Therapy with DF1001 and Nab-paclitaxel Safety/PK/PD Expansion
Expansion cohort of DF1001 in combination with nab-paclitaxel after evaluation for safety in the Combination Therapy with DF1001 and nab-paclitaxel Dose Escalation arm. Additional pharmacokinetic (PK) and pharmacodynamic (PD) samples included in this arm.
Drug: DF1001
Immunotherapy agent targeting NK cells.

Drug: Nab paclitaxel
A chemotherapy treatment combining paclitaxel with albumin

Experimental: Combination Therapy with DF1001 and Nivolumab Expansion in Urothelial Bladder Cancer
Combination therapy with DF1001 and nivolumab expansion cohort enrolling up to 20 patients with urothelial bladder cancer using the recommended phase 2 dose (RP2D) identified in the Combination Therapy with DF1001 and nivolumab arm.
Drug: DF1001
Immunotherapy agent targeting NK cells.

Drug: Nivolumab
Anti-PD-1 immunotherapy agent

Experimental: Monotherapy DF1001 Expansion in Metastatic Breast Cancer (HER2 High)
Monotherapy expansion cohort enrolling up to 20 patients with metastatic breast cancer with documented high expression of HER2 using the recommended phase 2 dose (RP2D) identified in the Monotherapy Dose Escalation arm.
Drug: DF1001
Immunotherapy agent targeting NK cells.

Experimental: Monotherapy DF1001 Expansion in NSCLC
Monotherapy expansion cohort enrolling up to 20 patients with non-small cell lung cancer with documented erbb2 amplification using the recommended phase 2 dose (RP2D) identified in the Monotherapy Dose Escalation arm.
Drug: DF1001
Immunotherapy agent targeting NK cells.

Experimental: Combination Therapy with DF1001 and Nivolumab Expansion in NSCLC
Combination therapy with DF1001 and nivolumab expansion cohort enrolling up to 20 patients with non-small cell lung cancer with documented low expression of HER2 using the recommended phase 2 dose (RP2D) identified in the Combination Therapy with DF1001 and nivolumab arm.
Drug: DF1001
Immunotherapy agent targeting NK cells.

Drug: Nivolumab
Anti-PD-1 immunotherapy agent

Experimental: Monotherapy DF1001 Expansion in Gastric Cancer
Monotherapy expansion cohort enrolling up to 20 patients with gastric cancer with documented high expression of HER2 using the recommended phase 2 dose (RP2D) identified in the Monotherapy Dose Escalation arm.
Drug: DF1001
Immunotherapy agent targeting NK cells.

Experimental: Combination Therapy with DF1001 and Nivolumab Expansion in Gastric Cancer
Combination therapy with DF1001 and nivolumab expansion cohort enrolling up to 20 patients with gastric cancer with documented low expression of HER2 using the recommended phase 2 dose (RP2D) identified in the Combination Therapy with DF1001 and nivolumab arm.
Drug: DF1001
Immunotherapy agent targeting NK cells.

Drug: Nivolumab
Anti-PD-1 immunotherapy agent

Experimental: Monotherapy DF1001 Expansion in Esophageal Cancer
Monotherapy expansion cohort enrolling up to 20 patients with esophageal cancer with documented high expression of HER2 using the recommended phase 2 dose (RP2D) identified in the Monotherapy Dose Escalation arm.
Drug: DF1001
Immunotherapy agent targeting NK cells.

Experimental: Combination Therapy with DF1001 and Nivolumab Expansion in Esophageal Cancer
Combination therapy with DF1001 and nivolumab expansion cohort enrolling up to 20 patients with esophageal cancer with documented low expression of HER2 using the recommended phase 2 dose (RP2D) identified in the Combination Therapy with DF1001 and nivolumab arm.
Drug: DF1001
Immunotherapy agent targeting NK cells.

Drug: Nivolumab
Anti-PD-1 immunotherapy agent




Primary Outcome Measures :
  1. Assessment of number of dose limiting toxicities experienced on study as defined per criteria in the study protocol [ Time Frame: First 3 weeks of treatment for each subject. ]
    To assess the number of adverse events experienced during the study that meet dose limiting toxicity criteria per the study protocol.

  2. Assess Overall Response Rate [ Time Frame: Through 90 days after completion of the study, an average of 1 year. ]
    To assess the Overall Response Rate (ORR) per RECIST version 1.1 criteria per an Independent Endpoint Review Committee (IERC)

  3. Assess number of adverse events observed during treatment with DF1001 in combination with Nivolumab [ Time Frame: Screening visit up to 28 days after last treatment on study. ]
    To assess the safety of DF1001 in Combination therapy with nivolumab by measuring Number of subjects with Treatment-Emergent Adverse Events according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0

  4. Assess number of adverse events observed during treatment with DF1001 in combination with Nab paclitaxel [ Time Frame: Screening visit up to 28 days after last treatment on study. ]
    To assess the safety of DF1001 in Combination therapy with Nab paclitaxel by measuring Number of subjects with Treatment-Emergent Adverse Events according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0


Secondary Outcome Measures :
  1. Evaluation of DF1001 Pharmacokinetics [ Time Frame: From start of treatment up through 28 days after last treatment. ]
    Concentration vs time of DF1001 will be measured using blood samples taken a various time points on study

  2. Evaluation of DF1001 Immunogenicity [ Time Frame: Every 3 weeks up to 28 days after last treatment. ]
    Evaluate the immunogenicity of DF1001 by measuring the number of patients developing anti-DF1001 antibodies

  3. Assess Best Overall Response [ Time Frame: Through 90 days after completion of the study, an average of 1 year. ]
    To assess Best Overall Response (BOR) by IERC (efficacy expansion cohorts).

  4. Assess Duration of Response [ Time Frame: From time of initiation of therapy until the date of first documented tumor progression, assessed up to 24 months ]
    To assess Duration of Response (DOR) for confirmed responses of DF1001 per an IERC (efficacy expansion cohorts).

  5. Assess Progression Free Survival (PFS) [ Time Frame: From time of initiation of therapy until the date of first documented tumor progression, assessed up to 24 months ]
    To assess Progression Free Survival (PFS) for DF1001 per an IERC (efficacy expansion cohorts).

  6. Assess Overall Survival (OS) Time. [ Time Frame: Time from enrollment in the study until death, measured up to 2 years after last treatment on study. ]
    To assess Overall Survival (OS)

  7. Assess ORR by Investigator Assessment. [ Time Frame: From time of initiation of therapy until the date of first documented tumor progression, assessed up to 24 months ]
    To assess confirmed ORR by Investigator Assessment for patients enrolled in the dose escalation phase and in the efficacy expansion phase.

  8. Assess DOR by Investigator Assessment. [ Time Frame: From time of initiation of therapy until the date of first documented tumor progression, assessed up to 24 months ]
    To assess DOR for confirmed responses by Investigator Assessment for patients enrolled in the dose escalation phase and in the efficacy expansion phase.

  9. Assess BOR by Investigator Assessment. [ Time Frame: Through 90 days after completion of the study, an average of 1 year. ]
    To assess confirmed BOR by Investigator Assessment for patients enrolled in the dose escalation phase and in the efficacy expansion phase.

  10. Assess PFS by Investigator Assessment. [ Time Frame: From time of initiation of therapy until the date of first documented tumor progression, assessed up to 24 months ]
    To assess PFS by Investigator Assessment for patients enrolled in the dose escalation phase and in the efficacy expansion phase.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: General (applies to all cohorts)

  1. Signed written informed consent.
  2. Male or female patients aged ≥ 18 years.
  3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at study entry and an estimated life expectancy of at least 3 months.
  4. Baseline Left Ventricular Ejection Fraction (LVEF) ≥ 55% measured by echocardiography (preferred) or multigated acquisition (MUGA) scan.
  5. Adequate hematological function.
  6. Adequate hepatic function.
  7. Adequate renal function.
  8. Effective contraception for women of child bearing potential (WOCBP) patients as defined by World Health Organization (WHO) guidelines for 1 "highly effective" method or 2 "effective" methods.

Inclusion Criteria: Dose Escalation

  1. Evidence of objective disease, but participation does not require a measurable lesion.
  2. Locally advanced or metastatic solid tumors, for which no standard therapy exists, or standard therapy has failed.
  3. HER2 expression by immunohistochemistry and/or erbb2 amplification and/or erbb2 activating mutations must be documented on either archival tissue or fresh tumor biopsy.

Inclusion Criteria: "3+3" Nivolumab Combination Cohort

  1. Eligible to receive nivolumab per its label for a malignancy of epithelial origin; or
  2. Have no standard therapy available, or standard therapy has failed, and must not have received nivolumab prior to joining the study.
  3. HER2 expression by immunohistochemistry and/or erbb2 amplification and/or erbb2 activating mutations must be documented on either archival tissue or fresh tumor biopsy.

Inclusion Criteria: "3+3" Nab paclitaxel Combination Cohort

  1. Patients must be eligible for treatment with nab-paclitaxel per its label, which includes metastatic breast cancer, after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. In this case, additional inclusion criteria include also no exposure to taxanes in the last 6 months, OR
  2. Patients whose tumor has no standard therapy or for which standard therapy has failed. In this case, patients should also not have been treated with a taxane over the last 6 months, OR
  3. First line advanced (unresectable/recurrent/metastatic) TNBC
  4. HER2 expression by immunohistochemistry and/or erbb2 amplification and/or erbb2 activating mutations must be documented on either archival tissue or fresh tumor biopsy

Inclusion Criteria: Safety/PK/PD Expansion Cohorts (Monotherapy and Combination Therapy)

  1. Fresh tumor biopsy must be obtained during the screening window.
  2. HER2 expression by immunohistochemistry (IHC).
  3. Disease must be measurable with at least 1 unidimensional measurable lesion by RECIST 1.1.

Inclusion Criteria: Urothelial Bladder Cancer Expansion Cohort(s)

  1. Disease must be measurable with at least 1 unidimensional measurable lesion by RECIST 1.1.
  2. Histologically or cytologically documented locally advanced or metastatic transitional cell carcinoma of the urothelium (including renal pelvis, ureters, urinary urothelial, urethra).
  3. Patients must have radiographic disease progression after their last line of therapy.
  4. Patients must have received a platinum containing chemotherapy and an anti PD-1 or anti PD-L1 for the treatment of urothelial bladder cancer.
  5. Patients must have experienced radiographic progression of disease during treatment with PD-1/PD-L1 containing therapy.
  6. Patients must have at least 1+ expression of HER2 by IHC.
  7. For patients that will receive DF1001 in combination with nivolumab: progression while under anti PD-(L)1 must have occurred within 6 months of patient inclusion
  8. A fresh tumor biopsy must be obtained during the screening window.

Inclusion Criteria: Breast Cancer (HER2 Low) Expansion Cohort

  1. Disease must be measurable with at least 1 unidimensional measurable lesion by RECIST 1.1
  2. Histologically documented (metastatic or locally advanced) breast cancer.
  3. Absence of erbb2 amplification by ISH and/or HER2 IHC of 0, 1+, or 2+. If Herceptest score is 0, HER2 must be detected by IHC on at least 1+ of the tumor cells.
  4. Patient must have progressed after one line of systemic chemotherapy. Treatment with a trastuzumab-containing ADC will be considered as a line of chemotherapy.
  5. Patients must have progressed (radiographically) after their last line of systemic therapy.
  6. HR-positive patients must have received hormone therapy and have progressed while receiving hormone therapy.
  7. A fresh tumor biopsy must be obtained during the screening window.

Inclusion Criteria: Breast Cancer (HER2 High) Expansion Cohort

  1. Disease must be measurable with at least 1 unidimensional measurable lesion by RECIST 1.1
  2. Histologically documented (metastatic or locally advanced) breast cancer.
  3. Erbb2 amplification by ISH and/or HER2 IHC of 3+, or 2+. If Herceptest score is 2+, ISH results should demonstrate erbb2 amplification.
  4. Patient must have received trastuzumab, pertuzumab, and a HER2-targeting ADC. Other anti HER2 lines of therapy are acceptable.
  5. Patient must have progressed after one line of systemic chemotherapy.
  6. HR-positive patients must have received hormone therapy and have progressed while receiving hormone therapy.
  7. A fresh tumor biopsy must be obtained during the screening window.

Inclusion Criteria: Basket erbb2 amplified Expansion Cohort

  1. Disease must be measurable with at least 1 unidimensional measurable lesion by RECIST 1.1.
  2. Patients with any solid tumor except breast cancer, gastric cancer, or esophageal cancer that have progressed after an HER2 targeting ADC, or patients with carcinoma of the salivary glands that have progressed after one line of systemic therapy
  3. Documented history of erbb2 amplification.
  4. Patients must have received at least one line of an approved or established therapy.
  5. A fresh tumor biopsy must be obtained during the screening window.

Inclusion Criteria: Gastric Cancer (HER2 High) Expansion Cohort

  1. Disease must be measurable with at least 1 unidimensional measurable lesion by RECIST 1.1.
  2. Advanced (unresectable/recurrent/metastatic) gastric cancer or cancer of the gastro-esophageal junction.
  3. Tumor must have been declared HER2 positive.
  4. Patients must have received a first line of therapy that included a platinum salt and a fluoropyridine in combination with trastuzumab or a biosimilar to trastuzumab.
  5. Patients must have progressed after the first line therapy.
  6. Patients must have received only one line of therapy for the treatment of metastatic disease.
  7. A fresh tumor biopsy must be obtained during the screening window.

Inclusion Criteria: Gastric Cancer (HER2 Low) Expansion Cohort

  1. Disease must be measurable with at least 1 unidimensional measurable lesion by RECIST 1.1.
  2. Advanced (unresectable/recurrent/metastatic) gastric cancer or cancer of the gastro-esophageal junction.
  3. Tumor must have been declared HER2 low; ISH non-amplified and/or HER2 IHC of 0, 1+ or 2+. If Herceptest score is 0, HER2 must be detected by IHC on at least 1+ of the tumor cells.
  4. Patients must have received a first line of therapy that included a platinum salt and a fluoropyridine in combination with an anti PD-1
  5. Patients must have progressed after the first line therapy.
  6. Progression while under anti PD-(L)1 must have occurred within 6 months of patient inclusion
  7. Patients must have received only one line of therapy for the treatment of metastatic disease.
  8. Disease must be measurable with at least 1 unidimensional measurable lesion by RECIST 1.1.
  9. A fresh tumor biopsy must be obtained during the screening window.

Inclusion Criteria: Esophageal Cancer (HER2 High) Expansion Cohort

  1. Disease must be measurable with at least 1 unidimensional measurable lesion by RECIST 1.1.
  2. Advanced (unresectable/recurrent/metastatic) esophageal cancer.
  3. Tumor must have been declared HER2 positive.
  4. Patients must have received a first line of therapy that included a platinum salt and a fluoropyridine in combination with trastuzumab or a biosimilar to trastuzumab.
  5. Patients must have progressed after the first line therapy.
  6. Patients must have received only one line of therapy for the treatment of metastatic disease.
  7. A fresh tumor biopsy must be obtained during the screening window.

Inclusion Criteria: Esophageal Cancer (HER2 Low) Expansion Cohort

  1. Disease must be measurable with at least 1 unidimensional measurable lesion by RECIST 1.1.
  2. Advanced (unresectable/recurrent/metastatic) esophageal cancer.
  3. Tumor must have been declared HER2 low; ISH non-amplified and/or HER2 IHC of 0, 1+ or 2+. If Herceptest score is 0, HER2 must be detected by IHC on at least 1+ of the tumor cells.
  4. Patients must have received a first line of therapy that included a platinum salt and a fluoropyridine in combination with an anti PD-1
  5. Patients must have progressed after the first line therapy.
  6. Progression while under anti PD-(L)1 must have occurred within 6 months of patient inclusion
  7. Patients must have received only one line of therapy for the treatment of metastatic disease.
  8. Disease must be measurable with at least 1 unidimensional measurable lesion by RECIST 1.1.
  9. A fresh tumor biopsy must be obtained during the screening window.

Inclusion Criteria: Non-small Cell Lung Cancer (HER2 Low) Expansion Cohort

  1. Disease must be measurable with at least 1 unidimensional measurable lesion by RECIST 1.1.
  2. Histologically confirmed NSCLC meeting stage criteria for stage IIIB, stage IV, or recurrent disease that has been confirmed to have HER2 expression (at least 1+, however, patients must not carry an erbb2 amplification) via archival or fresh biopsy tissue prior to study enrollment.
  3. Patients must have recurrent or progressive disease during or after platinum doublet-based chemotherapy OR must have recurrent or progressive disease within 6 months after completing platinum-based chemotherapy for local disease, including those with actionable genetic alterations.
  4. Patients must have received and progressed on or after anti-PD-(L)1 therapy including those with actionable genomic alterations for which an approved treatment exists
  5. Progression while under anti PD-(L)1 must have occurred within 6 months of patient inclusion
  6. Status for actionable mutations (EGFR, ALK, ROS1, RET, etc.) must be known (when testing is available as per country/region standard of care practices); patients with actionable mutations must have received and progressed on, have been intolerant to, or not be a candidate for standard tyrosine kinase inhibitors (TKIs) (as available per country/region standard of care practices).
  7. A fresh tumor biopsy must be obtained during the screening window.

Inclusion Criteria: Non-small Cell Lung Cancer (HER2 High) Expansion Cohort

  1. Disease must be measurable with at least 1 unidimensional measurable lesion by RECIST 1.1.
  2. Histologically confirmed NSCLC meeting stage criteria for stage IIIB, stage IV, or recurrent disease that has been confirmed to have amplification of erbb2 via archival or fresh biopsy tissue prior to study enrollment.
  3. Patients must have recurrent or progressive disease during or after platinum doublet-based chemotherapy OR must have recurrent or progressive disease within 6 months after completing platinum-based chemotherapy for local disease, including those with actionable genetic alterations.
  4. Patients must have received and progressed on or after anti-PD-(L)1 therapy including those with actionable genomic alterations for which an approved treatment exists
  5. Status for actionable mutations (EGFR, ALK, ROS1, RET, etc.) must be known (when testing is available as per country/region standard of care practices); patients with actionable mutations must have received and progressed on, have been intolerant to, or not be a candidate for standard tyrosine kinase inhibitors (TKIs) (as available per country/region standard of care practices).
  6. Patients with an erbb2 amplification must provide archival tissue. If archival tissue is not available, a fresh biopsy must be obtained during the screening window.

Exclusion Criteria:

1. Concurrent treatment with a non-permitted drug as in Non-Permitted Medicines and Therapies section. Previous treatment with drugs that specifically target the HER2 pathway (mAb or tyrosine kinase inhibitor [TKI]) is acceptable providing washout period (4 weeks for mAbs or protein therapeutics and 2 weeks for a TKI).

2. Concurrent anticancer treatment (eg, cytoreductive therapy, radiotherapy [with the exception of palliative bone directed radiotherapy], immune therapy, or cytokine therapy except for erythropoietin), major surgery (excluding prior diagnostic biopsy), concurrent systemic therapy with steroids or other immunosuppressive agents, or use of any investigational drug within 28 days before the start of study treatment. Short-term administration of systemic steroids (i.e., for allergic reactions or the management of immune-related adverse events [irAEs]) is allowed.

  1. Note: Patients receiving bisphosphonates are eligible provided treatment was initiated at least 14 days before the first dose of DF1001.
  2. Previous malignant disease other than the target malignancy to be investigated in this study within the last 3 years, with the exception of basal or squamous cell carcinoma of the skin or cervical carcinoma in situ.
  3. Rapidly progressive disease.
  4. Active or history of central nervous system (CNS) metastases.
  5. Receipt of any organ transplantation including autologous or allogeneic stem-cell transplantation.
  6. Significant acute or chronic infections (including historic positive test for human immunodeficiency virus [HIV], or active or latent hepatitis B or active hepatitis C tested during the screening window).
  7. Preexisting autoimmune disease (except for patients with vitiligo) needing treatment with systemic immunosuppressive agents for more than 28 days within the last 3 years or clinically relevant immunodeficiencies (eg, dys-gammaglobulinemia or congenital immunodeficiencies), or fever within 7 days of Day 1.
  8. Known severe hypersensitivity reactions to mAbs (≥ Grade 3 NCI-CTCAE v5.0), any history of anaphylaxis, or uncontrolled asthma (ie, 3 or more features of partly controlled asthma).
  9. Persisting toxicity related to prior therapy > Grade 1 NCI-CTCAE v5.0, however alopecia and sensory neuropathy ≤ Grade 2 is acceptable.
  10. Pregnancy or lactation in females during the study.
  11. Known alcohol or drug abuse.
  12. Serious cardiac illness
  13. NYHA III of IV heart failure or systolic dysfunction (LVEF < 55%)
  14. High-risk uncontrolled arrhythmias ie, tachycardia with a heart rate > 100/min at rest
  15. Significant ventricular arrhythmia (ventricular tachycardia) or higher-grade Atrioventricular block (AV-block; second-degree AV-block Type 2 [Mobitz 2] or third-degree AV-block)
  16. Angina pectoris requiring anti-anginal medication
  17. Clinically significant valvular heart disease
  18. Evidence of transmural infarction on ECG
  19. Poorly controlled hypertension (defined by: systolic > 180 mm Hg or diastolic > 100 mm Hg)
  20. Clinically relevant uncontrolled cardiac risk factors, clinically relevant pulmonary disease or any clinically relevant medical condition in the opinion of the Investigator that may limit participation in this study.
  21. Severe dyspnea at rest due to complications of advanced malignancy or requiring supplementary oxygen therapy.
  22. All other significant diseases (e.g., inflammatory bowel disease), which, in the opinion of the Investigator, might impair the patient's ability to participate
  23. Any psychiatric condition that would prohibit the understanding or rendering of informed consent.
  24. Legal incapacity or limited legal capacity.
  25. Incapable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol .

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04143711


Contacts
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Contact: Sean Rossi 671-588-0086 ext 7060 Sean.Rossi@Dragonflytx.com

Locations
Show Show 36 study locations
Sponsors and Collaborators
Dragonfly Therapeutics
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Responsible Party: Dragonfly Therapeutics
ClinicalTrials.gov Identifier: NCT04143711    
Other Study ID Numbers: DF1001-001
First Posted: October 29, 2019    Key Record Dates
Last Update Posted: December 6, 2022
Last Verified: December 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dragonfly Therapeutics:
HER-2
NK Cell
Immunotherapy
Metastatic Breast Cancer
Urothelial Bladder Cancer
Gastric Cancer
Esophageal Cancer
Gastroesophageal Junction Cancer
Non-small Cell Lung Cancer
Erbb2
DF1001
Additional relevant MeSH terms:
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Neoplasms
Paclitaxel
Nivolumab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Immune Checkpoint Inhibitors