Investigating CRB-701 for treating solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• O'Neal Comprehensive Cancer Center at University of Alabama-Birmingham
  Birmingham, Alabama, United States Recruiting
• City of Hope Cancer Center
  Duarte, California, United States Recruiting
• Moores Cancer Centre at UC San Diego Health
  San Diego, California, United States Recruiting
• Helen Diller Family Comprehensive Cancer Center - UCSF
  San Francisco, California, United States Recruiting
• Yale Cancer Center
  New Haven, Connecticut, United States Recruiting
• Florida Cancer Specialists
  Orlando, Florida, United States Recruiting

Study contacts

• Principal investigator: David Pinato, MD — Imperial College London
• Study coordinator: Ian Hodgson, PhD
• Email: Clinical@Corbuspharma.com
• Phone: +1 (617) 963-0105

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.