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Trial record 1 of 1 for:    NCT05496595
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DCBY02 as a Monotherapy in Patients With Advanced or Metastatic Solid Tumors

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ClinicalTrials.gov Identifier: NCT05496595
Recruitment Status : Recruiting
First Posted : August 11, 2022
Last Update Posted : March 16, 2023
Sponsor:
Information provided by (Responsible Party):
DynamiCure Biotechnology

Study Description
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Brief Summary:
Study DC-6001-101 Part A is a multicenter, open-label, Phase 1 study to assess the effects of anti-CD93 mAb (DCBY02) as a monotherapy in patients with advanced or metastatic solid tumors.

Condition or disease Intervention/treatment Phase
Advanced or Metastatic Solid Tumors Drug: DCBY02 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Multicenter, Open-Label, Dose Escalation, and Dose Expansion Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of DCBY02 as a Monotherapy in Patients With Advanced or Metastatic Solid Tumors
Actual Study Start Date : October 26, 2022
Estimated Primary Completion Date : September 2024
Estimated Study Completion Date : October 2024
Arms and Interventions
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Arm Intervention/treatment
Experimental: Part 1A Dose Escalation
Dose escalation to investigate safety, tolerability, and determine recommended phase 2 dose (RP2D) for DCBY02.
 Drug: DCBY02
A monoclonal antibody that binds to CD93, DCBY02 will be administered as a single intravenous (IV) infusion on Day 1 in each 21-day cycle.
Experimental: Part 2A Dose Expansion
Dose expansion to further investigate safety, tolerability, and preliminary evidence of antitumor activity. In addition to antitumor activity, PK and PD analysis may be used to support RP2D confirmation.
 Drug: DCBY02
A monoclonal antibody that binds to CD93, DCBY02 will be administered as a single intravenous (IV) infusion on Day 1 in each 21-day cycle.


Outcome Measures
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Primary Outcome Measures :
  1. Parts 1A/2A: Incidence and severity of adverse events graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 [ Time Frame: 2 years ]
  2. Part 1A: The proportion of patients experiencing dose limiting toxicity (DLT) events [ Time Frame: From first dose to Cycle 2 Day 8 (28 days) ]

Secondary Outcome Measures :
  1. Part 1A: Objective response rate (ORR) as determined per Investigator assessment [ Time Frame: 1 year ]
  2. Part 1A: Duration of response (DOR) as determined per Investigator assessment [ Time Frame: 1 year ]
  3. Part 1A: Disease control rate (DCR) as determined per Investigator assessment [ Time Frame: 1 year ]
  4. Part 1A: Progression free survival (PFS) as determined per Investigator assessment [ Time Frame: 1 year ]
  5. Part 1A: Overall survival (OS) [ Time Frame: 1 year ]
  6. Parts 1A/2A: Pharmacokinetic parameters of DCBY02: maximum observed concentration (Cmax) [ Time Frame: 2 years ]
  7. Parts 1A/2A: Pharmacokinetic parameters of DCBY02: area under the concentration-time curve (AUC) [ Time Frame: 2 years ]
  8. Parts 1A/2A: Pharmacokinetic parameters of DCBY02: clearance (CL) [ Time Frame: 2 years ]
  9. Parts 1A/2A: Pharmacokinetic parameters of DCBY02: volume of distribution (Vz) [ Time Frame: 2 years ]
  10. Parts 1A/2A: Pharmacokinetic parameters of DCBY02: half-life (t1/2) [ Time Frame: 2 years ]
  11. Parts 1A/2A: Incidence of anti-drug antibody (ADA) and neutralizing antibodies (NAbs) against DCBY02 [ Time Frame: 2 years ]

Eligibility Criteria
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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

Selected Inclusion Criteria:

Male or female patients ≥ 18 years of age.

Histologically or cytologically confirmed incurable or metastatic solid tumors - colorectal, gastric, non-small cell lung, renal cell, breast, hepatocellular, ovarian, cervical cancer, GBM or with a potential benefit from PD-1/PD-L1 blockade where hypoxia is associated with resistance to PD-1 blockade eg, as reported for or head and neck cancer and is not amenable to curative treatment.

The malignancy must have progressed after at least 1 available standard therapy for incurable disease, and the patient has failed or is intolerant to all available therapies known to be active for the malignancy and have meaningful impact on the disease.

Patients with unresectable or metastatic solid tumors, with the exemption of patients with GBM, must have a lesion that can be biopsied with acceptable clinical risk and agree to have a fresh biopsy at Screening and in the first week of Cycle 2.

At least 1 measurable lesion according to RECIST Version 1.1.

Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.

Adequate organ function and bone marrow reserve as indicated by the following laboratory assessments performed within 14 days prior to the first dose of study drug.

For female patients of childbearing potential must have a negative serum beta-human chorionic gonadotropin (β-hCG) pregnancy test and agree to use highly effective contraception.

For men who are not surgically sterile must agree to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agreement to refrain from donating sperm.

The patient is capable of understanding and complying with the protocol and has signed the required ICF. The appropriate ICF must be signed before relevant study procedures are performed. If applicable, the female partner of a male patient understands and signs the pregnant partner's ICF.

Selected Exclusion Criteria:

Treatment with anticancer therapy, including investigational therapy, within 4 weeks prior to the first dose of study drug.

Patients with > Grade 1 AEs (except Grade 2 alopecia or hearing impairment) related to previous treatment with anticancer or investigational therapy that do not resolve.

Systemic arterial thrombotic or embolic events, such as cerebrovascular accident (including ischemic attacks) or hemoptysis within 3 months prior to the first dose of study drug.

Systemic venous thrombotic events (eg, deep vein thrombosis) or pulmonary arterial events (eg, pulmonary embolism) within 1 month prior to the first dose of study drug. Patients with venous thrombotic events prior to the first dose of study drug on stable anticoagulation therapy are eligible.

Left ventricular ejection fraction (LVEF) < 50% or below the lower limit for normal institutional level.

Major surgery within 4 weeks and minor surgery within 2 weeks of the first dose of study drug; following surgeries, all surgical wounds must be healed and free of infection or dehiscence.

The patient has marked proteinuria ≥ 2 g/24 hours and/or nephrotic syndrome. Patients with proteinuria 2+ or greater urine dipstick reading should undergo further assessment, eg, a 24-hour urine collection.

Any other clinically significant comorbidities, such as uncontrolled pulmonary disease, active infection, or any other condition, which in the judgment of the Investigator, could compromise compliance with the protocol, interfere with the interpretation of study results, or predispose the patient to safety risks.

Known allergy or hypersensitivity to any component of the study drug.

Contacts and Locations
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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): NCT05496595


Contacts
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Contact: VP Head of Clinical Operations +1 (781) 373-9136 robertmaietta@dynamicure.com

Locations
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United States, Arizona
HonorHealth Recruiting
Scottsdale, Arizona, United States, 85258
Principal Investigator: Michael Gordon, MD         
United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Principal Investigator: Stephen Hodi, MD         
Sponsors and Collaborators
DynamiCure Biotechnology
More Information
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Responsible Party: DynamiCure Biotechnology
ClinicalTrials.gov Identifier: NCT05496595    
Other Study ID Numbers: DC-6001-101 Part A
First Posted: August 11, 2022    Key Record Dates
Last Update Posted: March 16, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms