A Phase 1/2 Study to Investigate CRB-701 in Solid Tumors

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Corbus Pharmaceuticals Inc.
Study ID
NCT06265727
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Solid Tumor, Adult

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CRB-701 — DRUG
    Nectin-4 targeted Antibody Drug Conjugate (ADC)
  • Anti-PD-1 — DRUG
    checkpoint inhibitor

Study Details

The goal of this clinical trial is to define a safe and effective dose of CRB-701 for participants with solid tumors that are expressing a protein called nectin-4. The main questions it aims to answer are: What is the the safe and effective dose of CRB-701? What cancers can be treated effectively with CRB-701? Participants will be asked to attend clinic and be given a intravenous infusion of CRB-701. They will have blood tests, CT or MRI Scans, and other assessments to measure whether CRB-701 has an effect on tumors.

Key Dates

Start date
Apr 1, 2024
Status verified
Jan 2026
Primary completion
Jan 16, 2027
Completion
Jan 27, 2027

Study Design

Enrollment
348 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A Dose Escalation - CRB-701 Dose Level 1
    CRB-701 Dose level 1, intravenous infusion over 30 mins, Dose schedule 1
  • Experimental: Part A Dose Escalation - CRB-701 Dose Level 2
    CRB-701 Dose Level 2, intravenous infusion over 30 mins, Dose schedule 1
  • Experimental: Part A Dose Escalation - CRB-701 Dose Level 3
    CRB-701 Dose Level 3, intravenous infusion over 30 mins, dose schedule 1
  • Experimental: Part A Dose Escalation - CRB-701 Dose Level 4
    CRB-701 Dose Level 4, intravenous infusion over 30 mins, dose schedule 1
  • Experimental: Part B Dose Optimization: CRB-701 High dose
    Selected high dose of CRB-701, intravenous infusion over 30 mins, dose schedule 1
  • Experimental: Part B Dose Optimization: CRB-701 low dose
    Selected Low dose of CRB-701, intravenous infusion over 30 mins
  • Experimental: Part C Dose Expansion - Cohort 1
    Recommended CRB-701 dose and schedule, intravenous infusion over 30 mins followed by infusion with anti-PD-1
  • Experimental: Part C Dose Expansion - Cohort 2
    Recommended CRB-701 dose and schedule, intravenous infusion over 30 mins
  • Experimental: Part C Dose Expansion - Cohort 3
    Recommended CRB-701 dose and schedule, intravenous infusion over 30 mins followed by infusion with anti-PD-1
  • Experimental: Part C Dose Expansion - Cohort 4
    Recommended CRB-701 dose and schedule, intravenous infusion over 30 mins
  • Experimental: Part C Dose Expansion - Cohort 5
    Recommended CRB-701 dose and schedule, intravenous infusion over 30 mins followed by infusion with anti-PD-1
  • Experimental: Part B Dose Optimization: CRB-701 high dose combined with anti-PD-1
    Selected high dose of CRB-701, intravenous infusion over 30 mins followed by infusion with anti-PD-1
  • Experimental: Part B Dose Optimization: CRB-701 low dose combined with anti-PD-1
    Selected low dose of CRB-701, intravenous infusion over 30 mins followed by infusion with anti-PD-1
  • Experimental: Part C Dose Expansion - Cohort 6
    Recommended CRB-701 dose and schedule, intravenous infusion over 30 mins
  • Experimental: Part C Dose Expansion - Cohort 7
    Recommended CRB-701 dose and schedule, intravenous infusion over 30 mins followed by infusion with anti-PD-1

Primary Outcome Measure

Part A: To confirm the safety and tolerability and determine MTD and PADR for CRB-701 [ Time Frame: 21 days ]

Central Contacts

Locations (15)

FacilityCityStateZIPSite coordinators
O'Neal Comprehensive Cancer Center at University of Alabama-BirminghamBirminghamAlabama35294
Rodney Carter
[email protected]
City of Hope Cancer CenterDuarteCalifornia91010
Rodney Carter
[email protected]
Moores Cancer Centre at UC San Diego HealthSan DiegoCalifornia92037
Rodney Carter
[email protected]
Helen Diller Family Comprehensive Cancer Center - UCSFSan FranciscoCalifornia94115
Rodney Carter
[email protected]
Rocky Mountain Cancer CentresDenverColorado80218-
Yale Cancer CenterNew HavenConnecticut06510
Rodney Carter
[email protected]
Florida Cancer SpecialistsOrlandoFlorida32806
Rodney Carter
[email protected]
University of ChicagoChicagoIllinois60637
Rodney Carter
[email protected]
Hope and Healing Cancer CenterHinsdaleIllinois60521-
Dana-Faber Cancer InstituteBostonMassachusetts02215
Rodney Carter
Nebraska Hematology OncologyLincolnNebraska68506-
Carolina BioOncology InstituteHuntersvilleNorth Carolina28078-
Texas OncologyTylerTexas75702
Rodney Carter
[email protected]
Virginia Cancer SpecialistsFairfaxVirginia22031-
Fred Hutchinson Cancer Center at University of WashingtonSeattleWashington98195-

Find similar trials in Birmingham, AL

By research site
O'Neal Comprehensive Cancer Center at University of Alabama-Birmingham· Birmingham, ALCity of Hope Cancer Center· Duarte, CAMoores Cancer Centre at UC San Diego Health· San Diego, CAHelen Diller Family Comprehensive Cancer Center - UCSF· San Francisco, CARocky Mountain Cancer Centres· Denver, COYale Cancer Center· New Haven, CT

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