First-in-Human Study of CRB-601-01 for Treating Advanced Solid Tumors

Program Overview

The study aims to find out if CRB-601, a new drug targeting a protein called avb8 integrin, is safe and effective for treating advanced solid tumors. Researchers will look at how the drug affects cancer, its side effects, and how much of it is in the blood. Participants will receive CRB-601 through an infusion every two weeks, either alone or with immunotherapy and radiation. Regular health checks and scans will monitor the treatment's impact. If the cancer progresses, participants will still be followed to understand long-term outcomes.

Description

This study is divided into three parts to test CRB-601, a new drug for advanced solid tumors:

Part A: Dose Escalation

• This part will find the safest dose of CRB-601 when given alone to patients whose cancer has returned or not responded to other treatments. Participants will receive increasing doses to find the best amount that can be safely given.

Part B: Combination Safety and Efficacy

• This part will test CRB-601 with immunotherapy, with or without targeted radiation. It will start with a safety phase to find the right dose and then expand to see how well it works in different cancers.

Part C: Dose Optimization

• This part will determine the best dose of CRB-601 when combined with immunotherapy and possibly radiation, based on results from earlier parts. Participants will be randomly assigned to different dose levels to see which works best.

Throughout the study, participants will have regular health checks, blood tests, and scans to monitor their response to the treatment. The study will continue until participants experience intolerable side effects, their cancer worsens, or they choose to stop. Researchers will also collect tissue and blood samples to study the drug's effects on the body.

Eligibility Criteria

Locations