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Investigating CRB-701 for treating solid tumors

A Phase 1/2 Study to Investigate the Safety, Pharmacokinetics, and Efficacy of CRB-701, an Antibody-drug Conjugate Targeting Nectin-4, in Patients With Advanced Solid Tumors

Phase1; Phase2 Interventional Corbus Pharmaceuticals Inc. · NCT06265727

This study is testing a new treatment called CRB-701 to see if it can safely help people with advanced solid tumors that have a specific protein called nectin-4.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment348 (estimated)
Ages18 Years and up
SexAll
SponsorCorbus Pharmaceuticals Inc. Industry-sponsored
Locations41 sites (Birmingham, Alabama and 40 other locations)
Trial IDNCT06265727 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the safety and effectiveness of CRB-701 in patients with advanced solid tumors that express the protein nectin-4. It consists of three parts: Part A focuses on determining the maximum tolerated dose (MTD) through dose escalation, Part B assesses the recommended Phase 2 dose (RP2D) using a Bayesian design, and Part C evaluates the RP2D in multiple expansion cohorts. Participants will receive intravenous infusions of CRB-701 and undergo various assessments, including blood tests and imaging scans, to monitor treatment effects.

Who should consider this trial

Good fit: Ideal candidates include adults with advanced or metastatic solid tumors that have progressed after at least one line of therapy and express nectin-4.

Not a fit: Patients with active or uncontrolled CNS metastases or significant comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors expressing nectin-4.

How similar studies have performed: While this approach is novel in targeting nectin-4, similar studies targeting specific tumor markers have shown promise in the past.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Birmingham, Alabama and 40 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Solid Tumor, Adultnectin-4
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.