Phase 1/2 Study of CRB-701 for Solid Tumors

This study is testing a new treatment called CRB-701 for adults with certain advanced solid tumors that have a protein called nectin-4. CRB-701 is an antibody-drug conjugate (ADC), which means it's designed to deliver a drug directly to cancer cells. Researchers want to find a safe and effective dose of CRB-701, sometimes in combination with another drug called anti-PD-1 (a checkpoint inhibitor). The study will look at how safe CRB-701 is and how well it shrinks tumors. You might be able to join if your cancer expresses nectin-4 and has progressed after other treatments, or if there are no other standard treatments available. For some head and neck cancers (HNSCC), you might be able to join as a first-line therapy. The study plans to enroll 348 participants.

Study design
This is an open-label, Phase 1/2 study with three parts, designed to find the best dose of CRB-701 alone and in combination with anti-PD-1.
What's involved
You will receive CRB-701 through an intravenous infusion. You will also have blood tests, CT or MRI scans, and other assessments to monitor the treatment's effects.
Compensation
Not stated in the trial record.
Follow-up
The study will evaluate how well the treatment works in terms of Objective Response Rate (ORR) for up to 6 months.

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NCT06265727

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Corbus Pharmaceuticals Inc.
~348 participants
Updated 2026-01-08 on ClinicalTrials.gov
What's tested:CRB-701Anti-PD-1

At a glance

Recruiting sites
35 of 41 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part A: To confirm the safety and tolerability and determine MTD and PADR for CRB-701
Measured over 21 days
+1 more outcome measured
Solid Tumor, Adult
41 sites across 18 states
United Kingdom9
France4
Italy4
Romania4
Spain4
California3
Illinois2
Alabama1
  • David Pinato, MD · PRINCIPAL_INVESTIGATOR · Imperial College London
  • Ian Hodgson, PhD · STUDY_DIRECTOR · Corbus International Ltd
  • Ari Rosenberg, MD · PRINCIPAL_INVESTIGATOR · University of Chicago

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Eligibility criteria

Inclusion

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

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.
  • Part A: To confirm the safety and tolerability and determine MTD and PADR for CRB-70121 days

    Occurrence of Dose Limiting Toxicities as defined in the protocol

  • Part B & C: To evaluate efficacy in terms of Objective Response Rate (ORR)Up to 6 months

    ORR is the percentage of participants that achieve a response (CR + PR) using RECIST 1.1