CRB-601 Combination Therapy for Cancer

Recruiting at 25 trial locations

Overseen By Ian Hodgson, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Corbus Pharmaceuticals Inc.

Disqualifiers: Cardiovascular events, Liver disease, Autoimmune, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

156 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to determine the safety, blood concentrations and treatment effect of CRB-601 in combination with immunotherapy or immune-priming radiotherapy in patients who have advanced solid tumors (cancer) and have exhausted other therapeutic options.CRB-601 targets a protein called avb8 integrin which is expressed by some cancers and not others. This study will focus on tumor types which are know to highly or moderately express this protein. Researchers will evaluate the side effects caused by treatment, levels of CRB-601 in the blood, and the effect on the participant cancer. This will help researchers understand the right dose of CRB-601 to use for treatment and whether it is an effective treatment to combine with standard of care treatments such as immunotherapy. It will also help the researchers understand whether combining CRB-601 with standard-of-care immunotherapy and immune-priming radiotherapy is a safe and effective approach to treat cancer. Participants in the study will receive CRB-601 via an infusion every two weeks either alone or in combination with immunotherapy and immune-priming radiotherapy. For patients receiving the immune-priming radiotherapy they will receive three doses of radiotherapy focused on a single tumor. There will be assessments to check on the participants general health status (including blood tests) and adverse effects. Participants will also receive regular CT or MRI scans to evaluate the effect of CRB-601 on their cancer. Participants will continue to visit the clinic every two weeks while they are receiving benefit from treatment. If their cancer progresses, participants will be asked to continue to be followed-up by the researchers to understand long-term outcomes, even if they receive other treatments.

Research Team

Jeff Clarke, MD

Principal Investigator

Duke University, NC, USA

Christian Ottensmeier, MD

Principal Investigator

Liverpool University, UK

Dominic Smethurst, MD

Principal Investigator

Corbus Pharmaceuticals Inc.

Eligibility Criteria

This trial is for patients with advanced solid tumors who have tried all other treatments. It's aimed at those whose cancers express a specific protein, avb8 integrin. Participants will receive the experimental drug CRB-601, alone or with immunotherapy and targeted radiotherapy.

Inclusion Criteria

Measurable disease on imaging as assessed by RECIST 1.1

My physical ability is limited but I can still take care of myself.

Life expectancy of more than 12 weeks

Exclusion Criteria

Other conditions that in the opinion of the Investigator would compromise the outcomes of the study

Systemic autoimmune disease

I have not had interstitial lung disease in the last 6 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Part A: Dose Escalation

Evaluate the safety, tolerability, and determine the MTD of CRB-601 administered as monotherapy

28 days per cycle

Visits every 2 weeks

Part B: Combination Safety Lead-in and Signal Seeking

Assess the safety and tolerability of CRB-601 combined with anti-PD(L)-1 therapy, with or without SBRT

6 months

Visits every 2 weeks

Part C: Dose Optimization

Determine the recommended Phase 2 dose by evaluating the efficacy of CRB-601 in combination with anti-PD(L)-1, with or without SBRT

6 months

Visits every 2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

Treatment Details

Interventions

• Anti-PD-1 monoclonal antibody
• CRB-601
• Immune-priming single lesion SBRT

Trial Overview Researchers are testing CRB-601, an antibody targeting avb8 integrin in cancer cells, combined with anti-PD-1 immunotherapy and focused radiotherapy. They want to find the right dose of CRB-601 and see if it's safe and effective when used with these standard treatments.

Participant Groups

Group I: Part C - Low dose CRB-601, anti-PD(L)-1 with or without SBRT Experimental Treatment 3 Interventions

Participants will received a low dose of CRB-601(defined in Part A \& B), standard of care dose of anti-PD(L)-1 therapy with or without 3 x 8gy doses of immune priming SBRT focused on a single lesion (as determined in Part B).

Group II: Part C - High dose CRB-601, anti-PD(L)-1 with or without SBRT Experimental Treatment 3 Interventions

Participants will received a high dose of CRB-601(defined in Part A \& B), standard of care dose of anti-PD(L)-1 therapy with or without 3 x 8gy doses of immune priming SBRT focused on a single lesion (as determined in Part B).

Group III: Part B/Cohort 2 low dose CRB-601, anti-PD(L)-1 therapy and SBRT Experimental Treatment 3 Interventions

Participants will received a low dose of CRB-601(defined in Part A), standard of care dose of anti-PD(L)-1 therapy and 3 x 8gy doses of immune priming SBRT focused on a single lesion.

Group IV: Part B/Cohort 2 high dose CRB-601, anti-PD(L)-1 therapy and SBRT Experimental Treatment 3 Interventions

Participants will received a high dose of CRB-601(defined in Part A), standard of care dose of anti-PD(L)-1 therapy and 3 x 8gy doses of immune priming SBRT focused on a single lesion.

Group V: Part B/Cohort 1: Dose level (low) CRB-601 monotherapy in combination with anti-PD(L)-1 Experimental Treatment 2 Interventions

Dose (defined in Part A) of CRB-601 administered intravenously in combination with anti-PD(L)-1 therapy dosed as per label.

Group VI: Part B/Cohort 1: Dose level (high) CRB-601 monotherapy in combination with anti-PD(L)-1 Experimental Treatment 2 Interventions

High dose CRB-601 (defined in Part A) of CRB-601 administered intravenously in combination with anti-PD(L)-1 therapy dosed per label.

Group VII: Part A: Dose 3 of CRB-601 monotherapy Experimental Treatment 1 Intervention

Dose 3 of CRB-601 (30mg/Kg) administered intravenously every two weeks

Group VIII: Part A: Dose 2 of CRB-601 monotherapy Experimental Treatment 1 Intervention

Dose 2 of CRB-601 (10mg/Kg) administered intravenously every two weeks

Group IX: Part A: Dose 1 CRB-601 monotherapy Experimental Treatment 1 Intervention

Dose 1 of CRB-601 (3mg/Kg) administered intravenously every two weeks

Who Is Running the Clinical Trial?

Corbus Pharmaceuticals Inc.

Lead Sponsor

Trials

9

Recruited

1,800+