Recruiting

Phase 1

Phase 2

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

Sponsor:

Corbus Pharmaceuticals Inc.

Code:

NCT06265727

Conditions

Solid Tumor, Adult

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CRB-701

Anti-PD-1

Study Details

Brief summary:

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.

Conditions

Solid Tumor, Adult

Study ID

NCT06265727

Start date

Apr 1, 2024

Status verified date

Jan, 2026

Completion date

Jan 27, 2027

Anticipated

Primary completion date

Jan 16, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Confirmed diagnosis of select advanced or metastatic nectin-4 expressing solid tumors that have progressed having exhausted all appropriate lines of therapy or have no other standard therapy with proven clinical benefit. In Part C, HNSCC participants may enroll as first-line therapy.

Exclusion Criteria:

Active of uncontrolled CNS metastases
History of solid tumors other than the diseases under study
History of and/or current cardiovascular events or conditions in the previous 6 months
Pre-existing >/= Grade 2 neuropathy
Hemoglobin A1C (HbA1C) >/= 8%, uncontrolled diabetes mellitus or know diabetic neuropathy
Active ocular disease at baseline
Chronic severe liver disease or live cirrhosis
Interstitial lung disease or pneumonitis within 6 months on initiating treatment on study
Other significant cormorbidities.

Study Design

Enrollment

348 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

CRB-701

Nectin-4 targeted Antibody Drug Conjugate (ADC)

Anti-PD-1

checkpoint inhibitor

Primary outcome measure

Part A: To confirm the safety and tolerability and determine MTD and PADR for CRB-701 [ Time Frame: 21 days ]
Part B & C: To evaluate efficacy in terms of Objective Response Rate (ORR) [ Time Frame: Up to 6 months ]

Central Contacts and Locations

Central contacts

Ian Hodgson, PhD

+1 (617) 963-0105 Clinical@Corbuspharma.com

Rodney Carter, BSc

Clinical@Corbuspharma.com

Locations

O'Neal Comprehensive Cancer Center at University of Alabama-Birmingham

Recruiting

Birmingham, Alabama, United States, 35294

Contacts

Rodney Carter

clinical@corbuspharma.com

City of Hope Cancer Center

Recruiting

Duarte, California, United States, 91010

Contacts

Rodney Carter

Clinical@corbuspharma.com

Moores Cancer Centre at UC San Diego Health

Recruiting

San Diego, California, United States, 92037

Contacts

Rodney Carter

Clinical@corbuspharma.com

Helen Diller Family Comprehensive Cancer Center - UCSF

Recruiting

San Francisco, California, United States, 94115

Contacts

Rodney Carter

clinical@corbuspharma.com

Yale Cancer Center

Recruiting

New Haven, Connecticut, United States, 06510

Contacts

Rodney Carter

Clinical@corbuspharma.com

Florida Cancer Specialists

Recruiting

Orlando, Florida, United States, 32806

Contacts

Rodney Carter

clinical@corbuspharma.com

University of Chicago

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Rodney Carter

Clinical@corbuspharma.com

Dana-Faber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Texas Oncology

Recruiting

Tyler, Texas, United States, 75702

Contacts

Rodney Carter

Clinical@corbuspharma.com

Fred Hutchinson Cancer Center at University of Washington

Recruiting

Seattle, Washington, United States, 98195

More Information

Sponsor

Corbus Pharmaceuticals Inc.

Last update posted

Jan 8, 2026

Last verified

Jan, 2026

Keywords

nectin-4

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Corbus Pharmaceuticals Inc. on 2026-01-08.