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DCBY02 or DCSZ11 as a Monotherapy in Patients With Advanced or Metastatic 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: NCT05496595
Recruitment Status : Recruiting
First Posted : August 11, 2022
Last Update Posted : November 10, 2022
Sponsor:
Information provided by (Responsible Party):
DynamiCure Biotechnology

Tracking Information
First Submitted Date  ICMJE August 9, 2022
First Posted Date  ICMJE August 11, 2022
Last Update Posted Date November 10, 2022
Actual Study Start Date  ICMJE October 26, 2022
Estimated Primary Completion Date September 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 9, 2022)
  • Part 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 ]
  • Part 1A: The proportion of patients experiencing dose limiting toxicity (DLT) events [ Time Frame: From first dose to Cycle 2 Day 8 (28 days) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 9, 2022)
  • Part 1A: Objective response rate (ORR) as determined per Investigator assessment [ Time Frame: 1 year ]
  • Part 1A: Duration of response (DOR) as determined per Investigator assessment [ Time Frame: 1 year ]
  • Part 1A: Disease control rate (DCR) as determined per Investigator assessment [ Time Frame: 1 year ]
  • Part 1A: Progression free survival (PFS) as determined per Investigator assessment [ Time Frame: 1 year ]
  • Part 1A: Overall survival (OS) [ Time Frame: 1 year ]
  • Part 1A/2A: Pharmacokinetic parameters of DCBY02: maximum observed concentration (Cmax) [ Time Frame: 2 years ]
  • Part 1A/2A: Pharmacokinetic parameters of DCBY02: area under the concentration-time curve (AUC) [ Time Frame: 2 years ]
  • Part 1A/2A: Pharmacokinetic parameters of DCBY02: clearance (CL) [ Time Frame: 2 years ]
  • Part 1A/2A: Pharmacokinetic parameters of DCBY02: volume of distribution (Vz) [ Time Frame: 2 years ]
  • Part 1A/2A: Pharmacokinetic parameters of DCBY02: half-life (t1/2) [ Time Frame: 2 years ]
  • Part 1A/2A: Incidence of anti-drug antibody (ADA) and neutralizing antibodies (NAbs) against DCBY02 [ Time Frame: 2 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE DCBY02 or DCSZ11 as a Monotherapy in Patients With Advanced or Metastatic Solid Tumors
Official Title  ICMJE A Phase 1, Multicenter, Open-Label, Dose Escalation, and Dose Expansion Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of DCBY02 (Part A) or DCSZ11 (Part B) as a Monotherapy in Patients With Advanced or Metastatic Solid Tumors
Brief Summary Study DC-6001-101 is a multicenter, open-label, Phase 1 study to assess the effects of anti-CD93 mAbs as a monotherapy in patients with advanced or metastatic solid tumors. The study comprises Part A (compound DCBY02) and Part B (compound DCSZ11, not yet active).
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 Advanced or Metastatic Solid Tumors
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Part 1A Dose Escalation
    Dose escalation to investigate safety, tolerability, and determine recommended phase 2 dose (RP2D) for DCBY02.
    Intervention: Drug: DCBY02
  • 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.
    Intervention: Drug: DCBY02
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: August 9, 2022)
96
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2024
Estimated Primary Completion Date September 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

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: VP Head of Clinical Operations +1 (781) 373-9136 robertmaietta@dynamicure.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05496595
Other Study ID Numbers  ICMJE DC-6001-101 (Part A)
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
Current Responsible Party DynamiCure Biotechnology
Original Responsible Party Same as current
Current Study Sponsor  ICMJE DynamiCure Biotechnology
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account DynamiCure Biotechnology
Verification Date August 2022

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