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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A Phase 1/2 Study to Investigate CRB-701 in Solid Tumors
At a glance
Conditions
Where it's being run
41 sites across 18 statesStudy leadership
- David Pinato, MD · PRINCIPAL_INVESTIGATOR · Imperial College London
- Ian Hodgson, PhD · STUDY_DIRECTOR · Corbus International Ltd
- Ari Rosenberg, MD · PRINCIPAL_INVESTIGATOR · University of Chicago
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- 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