Phase 1/2 Study to Investigate CRB-601 in Patients with Advanced Solid Tumours
Research type
Research Study
Full title
A Phase 1/2 Study to Investigate the Safety, Pharmacokinetics and Efficacy of CRB-601, a Monoclonal Antibody against Integrin αvβ8, in Patients with Advanced Solid Tumors
IRAS ID
1010331
Contact name
Ian Hodgson
Contact email
Sponsor organisation
Corbus Pharmaceutical Inc.
Clinicaltrials.gov Identifier
Research summary
This is a phase 1/2 clinical trial designed to evaluate the safety, pharmacokinetics, and efficacy of CRB-601 in participants with advanced solid tumours.
There are 3 parts to the study:
Part A: the dose of CRB-601 will be gradually increased in subsequent small groups of participants, to determine the maximum tolerated dose (MTD). Participants will be treated on 28-day cycles, with CRB-601 dosing every 2 weeks. A Safety Review Committee (SRC) will recommend the optimal dose levels to test in Parts B-C.
Part B: Participants will receive the optimal dose levels of CRB-601 determined in Part A combined with an Anti PD-L1. Depending on the tumour type, some participants will also receive radiation therapy. Based on the analysis of the data, the SRC will determine a selected CRB-601 dose for a further group of participants to receive in Part B. Finally, the SRC will then select the doses of CRB-601 and tumour-types to test in Part C.
Part C: The doses of CRB-601 selected in Part B will be randomly allocated to participants. CRB-601 will be given to participants in combination with an Anti PD-L1, and depending on the tumour type, some participants will also receive radiation therapy. The recommended phase 2 dose of CRB-601 will be determined by SRC review.
For all enrolled participants dosing will continue until intolerable toxicity related to the study intervention, death, withdrawal of consent, pregnancy, start of new anti-cancer therapy, progressive disease, any medical condition that may jeopardise participant safety, or the Investigator’s/Sponsor’s decision that stopping dosing is in the participant's best interest.
The overall study duration is expected to be approximately 28 months, including approximately 6 months for Part A, 14 months for Part B, and 8 months for Part C.
Approximately 156 participants are expected to be enrolled into the study, including 36 participants in Part A, 80 participants in Part B, and 40 participants in Part C.
REC name
London - London Bridge Research Ethics Committee
REC reference
24/LO/0802
Date of REC Opinion
13 Dec 2024
REC opinion
Further Information Favourable Opinion