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Phase 1 Study of INBRX-109 in Subjects With Locally Advanced or Metastatic Solid Tumors Including Sarcomas

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ClinicalTrials.gov Identifier: NCT03715933
Recruitment Status : Recruiting
First Posted : October 23, 2018
Last Update Posted : July 22, 2021
Sponsor:
Information provided by (Responsible Party):
Inhibrx, Inc.

Tracking Information
First Submitted Date  ICMJE October 11, 2018
First Posted Date  ICMJE October 23, 2018
Last Update Posted Date July 22, 2021
Actual Study Start Date  ICMJE October 10, 2018
Estimated Primary Completion Date August 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 22, 2018)
  • Frequency and severity of adverse events of INBRX-109 [ Time Frame: Up to 2 years ]
    Adverse events will be assessed and severity assigned by using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0.
  • Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of INBRX-109 [ Time Frame: Up to 2 years ]
    The MTD and/or RP2D of INBRX-109 will be determined.
Original Primary Outcome Measures  ICMJE
 (submitted: October 19, 2018)
Safety (adverse events) of INBRX-109 [ Time Frame: Up to 2 years ]
Adverse events will be assessed and severity assigned by using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 19, 2018)
  • Area under the serum concentration time curve (AUC) of INBRX-109 [ Time Frame: Up to 2 years ]
    Area under the serum concentration time curve (AUC) of INBRX-109 will be determined.
  • Immunogenicity of INBRX-109 [ Time Frame: Up to 2 years ]
    Frequency of ant-drug antibodies (ADA) against INBRX-109 will be determined.
  • Maximum observed serum concentration (Cmax) of INBRX-109 [ Time Frame: Up to 2 years ]
    Maximum observed serum concentration (Cmax) of INBRX-109 will be determined.
  • Trough observed serum concentration (Ctrough) of INBRX-109 [ Time Frame: Up to 2 years ]
    Trough observed serum concentration (Cmax) of INBRX-109 will be determined.
  • Time to Cmax (Tmax) of INBRX-109 [ Time Frame: Up to 2 years ]
    Time to Cmax (Tmax) of INBRX-109 will be determined.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 19, 2018)
Anti-tumor activity of INBRX-109 [ Time Frame: Up to 2 years ]
Tumor response will be determined by RECISTv1.1.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Phase 1 Study of INBRX-109 in Subjects With Locally Advanced or Metastatic Solid Tumors Including Sarcomas
Official Title  ICMJE An Open-Label, Multicenter, First-in-Human, Dose-Escalation Phase 1 Study of INBRX-109 in Subjects With Locally Advanced or Metastatic Solid Tumors Including Sarcomas
Brief Summary This is a first-in-human, open-label, non-randomized, three-part phase 1 trial of INBRX-109, which is a recombinant humanized tetravalent antibody targeting the human death receptor 5 (DR5).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Solid Tumors
  • Malignant Pleural Mesothelioma
  • Gastric Adenocarcinoma
  • Colorectal Adenocarcinoma
  • Sarcoma
  • Pancreatic Adenocarcinoma
  • Ewing Sarcoma
  • Chondrosarcoma
Intervention  ICMJE
  • Drug: INBRX-109
    Tetravalent DR5 Agonist Antibody
  • Drug: Carboplatin
    Chemotherapy
  • Drug: Cisplatin
    Chemotherapy
  • Drug: Pemetrexed
    Chemotherapy
  • Drug: 5-fluorouracil
    Chemotherapy
  • Drug: Irinotecan
    Chemotherapy
  • Drug: Temozolomide
    Chemotherapy
Study Arms  ICMJE
  • Experimental: Dose Escalation
    INBRX-109 will be escalated (3+3 design) in subjects with locally advanced or metastatic solid tumors including sarcomas.
    Intervention: Drug: INBRX-109
  • Experimental: Expansion Malignant Pleural Mesothelioma
    Subjects with malignant pleural mesothelioma will be treated with single-agent INBRX-109 at either the MTD or RP2D.
    Intervention: Drug: INBRX-109
  • Experimental: Expansion Gastric Adenocarcinoma
    Subjects with gastric adenocarcinoma will be treated with single-agent INBRX-109 at either the MTD or RP2D.
    Intervention: Drug: INBRX-109
  • Experimental: Expansion Colorectal Adenocarcinoma
    Subjects with colorectal (CRC) adenocarcinoma will be treated with single-agent INBRX-109 at either the MTD or RP2D.
    Intervention: Drug: INBRX-109
  • Experimental: Expansion Sarcomas
    Subjects with certain sarcoma subtypes will be treated with single-agent INBRX-109 at either the MTD or RP2D.
    Intervention: Drug: INBRX-109
  • Experimental: Combination Expansion Malignant Pleural Mesothelioma
    Subjects with malignant pleural mesothelioma will be treated with INBRX-109 in combination with chemotherapies (carboplatin, cisplatin, carboplatin and pemetrexed, or cisplatin and pemetrexed)
    Interventions:
    • Drug: INBRX-109
    • Drug: Carboplatin
    • Drug: Cisplatin
    • Drug: Pemetrexed
  • Experimental: Combination Expansion Pancreatic Adenocarcinoma
    Subjects with pancreatic adenocarcinoma will be treated with INBRX-109 in combination with 5FU/irinotecan based chemotherapy
    Interventions:
    • Drug: INBRX-109
    • Drug: 5-fluorouracil
    • Drug: Irinotecan
  • Experimental: Combination Expansion Ewing Sarcoma
    Subjects with Ewing sarcoma will be treated with INBRX-109 in combination with irinotecan/temozolomide based chemotherapy
    Interventions:
    • Drug: INBRX-109
    • Drug: Irinotecan
    • Drug: Temozolomide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 16, 2021)
172
Original Estimated Enrollment  ICMJE
 (submitted: October 19, 2018)
80
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date August 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Escalation: Histologically or cytologically-confirmed advanced/metastatic or non-resectable solid tumors, including sarcoma, that are refractory or intolerant to standard therapy, or for which no standard therapy exists that is likely to confer any clinical benefit.
  • Expansion Cohorts: Malignant pleural mesothelioma, gastric adenocarcinoma, colorectal adenocarcinoma, pancreatic adenocarcinoma and certain sarcoma subtypes (e.g., chondrosarcoma, Ewing sarcoma) with locally advanced or metastatic, non-resectable disease, that are refractory or intolerant to standard therapy, or for which no standard therapy exists that is likely to confer any clinical benefit.
  • Measurable disease as defined by RECISTv1.1 (or modified RECIST for mesothelioma) criteria.
  • Adequate hematologic, coagulation, hepatic and renal function as defined per protocol.
  • Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 for Part 1 and ECOG PS of 0, 1 or 2 for Parts 2 and 3.

Exclusion Criteria:

  • Prior treatment with or exposure to DR5 agonists.
  • Receipt of investigational agents or devices, anticancer therapy and radiotherapy (with the exception of palliative localized radiation) within 4 weeks prior to the first dose of study drug, and liver-directed therapies (i.e., RFA, TACE/embolization, cryotherapy, SBRT) within 12 weeks prior to the first dose of study drug. Exceptions per protocol.
  • Subject has undergone allogeneic hematopoietic stem cell or bone marrow transplantation within the last 5 years. Exception: Participants who have had a stem cell or bone marrow transplant > 5 years ago are eligible for enrollment, as long as there are no symptoms of graft-versus-host disease (GVHD).
  • Prior or concurrent malignancies. Exception: Subjects with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessments of INBRX-109.
  • Hematologic malignancies.
  • Known or active primary central nervous system (CNS) tumors, leptomeningeal disease and CNS metastases. Exception: Subjects with previously treated, asymptomatic, and clinically stable CNS metastases may be allowed study entry if certain criteria apply.
  • Subjects with chronic liver diseases including but not limited to cirrhosis, NASH, alcohol-related liver disease, hemochromatosis, Wilson's disease, alpha-1 antitrypsin deficiency, hepatic or biliary autoimmune disorders (i.e., primary biliary cholangitis, autoimmune hepatitis).
  • Acute viral or toxic liver disease within 4 weeks prior to the first dose of study drug.
  • Evidence or history of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection.
  • Clinically significant cardiac condition, including myocardial infarction, uncontrolled angina, cerebrovascular accident, or other acute uncontrolled heart disease < 3 months; left ventricular ejection fraction (LVEF) < 50%; New York Heart Association (NYHA) Class III or IV congestive heart failure; or uncontrolled hypertension. Active, hemodynamically significant pulmonary embolism within 3 months prior to enrollment on this trial.
  • Major surgery within 4 weeks prior to enrollment on this trial.
  • Systemic infection requiring antibiotics within 2 weeks prior to the first dose of study drug.
  • Part 3: Sensitivity or contraindications to carboplatin, cisplatin, pemetrexed, fluorouracil, irinotecan, or temozolomide.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Kevin Bayer, Director Clin Ops 858-500-7833 clinicaltrials@inhibrx.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03715933
Other Study ID Numbers  ICMJE Ph1 INBRX-109
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Inhibrx, Inc.
Study Sponsor  ICMJE Inhibrx, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Klaus Wagner, CMO Inhibrx, Inc.
PRS Account Inhibrx, Inc.
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP