CRB-701 for Cancer

Recruiting at 46 trial locations

Overseen By Ian Hodgson, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Corbus Pharmaceuticals Inc.

Disqualifiers: CNS metastases, Cardiovascular events, Diabetes, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

348 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the purpose of this trial?

The goal of this clinical trial is to define a safe and effective dose of CRB-701 for participants with solid tumors that are expressing a protein called nectin-4. The main questions it aims to answer are: What is the the safe and effective dose of CRB-701 when used alone? What cancers can be treated effectively with CRB-701? Participants will be asked to attend clinic and be given a intravenous infusion of CRB-701 on its own. They will have blood tests and other assessments to measure whether CRB-701 will have CT or MRI scans to measure the effect on tumors.

Research Team

Ari Rosenberg, MD

Principal Investigator

University of Chicago

David Pinato, MD

Principal Investigator

Imperial College London

Ian Hodgson, PhD

Principal Investigator

Corbus International Ltd

Eligibility Criteria

This trial is for individuals with solid tumors that have a protein called nectin-4. Participants will need to visit the clinic for intravenous infusions and undergo blood tests, CT or MRI scans to monitor effects on their tumors.

Inclusion Criteria

My cancer expresses nectin-4 and has worsened after treatment or has no other treatment options.

Exclusion Criteria

I have brain metastases that are not currently under control.

I have had cancer types other than the one currently being studied.

I have moderate to severe nerve damage.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Part A involves dose escalation to determine the maximum tolerated dose (MTD) of CRB-701 using the Bayesian optimal interval design.

21 days

Multiple visits for dose administration and monitoring

Dose Optimization

Part B involves determining the recommended Phase 2 dose (RP2D) of CRB-701 by evaluating two dose levels in separate cohorts.

Up to 6 months

Regular visits for dose administration and assessments

Dose Expansion

Part C involves evaluating the RP2D dose of CRB-701 in five planned expansion cohorts using Simon's optimal two-stage design.

Up to 6 months

Regular visits for dose administration and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• CRB-701

Trial Overview The study is testing CRB-701 in patients with solid tumors. It aims to determine the safe and effective dosage of CRB-701 when administered alone and its effectiveness against various cancers.

Participant Groups

Group I: Part C Dose Expansion - Cohort 7 Experimental Treatment 2 Interventions

Recommended Phase 2 dose and schedule of CRB-701, intravenous infusion over 30 mins followed by infusion with anti-PD-1

Group II: Part C Dose Expansion - Cohort 6 Experimental Treatment 1 Intervention

Recommended Phase 2 dose and schedule of CRB-701, intravenous infusion over 30 mins

Group III: Part C Dose Expansion - Cohort 5 Experimental Treatment 2 Interventions

Recommended Phase 2 dose and schedule of CRB-701, intravenous infusion over 30 mins followed by infusion with anti-PD-1

Group IV: Part C Dose Expansion - Cohort 4 Experimental Treatment 1 Intervention

Recommended Phase 2 dose of CRB-701 and schedule, intravenous infusion over 30 mins

Group V: Part C Dose Expansion - Cohort 3 Experimental Treatment 2 Interventions

Recommended Phase 2 dose and schedule of CRB-701, intravenous infusion over 30 mins followed by infusion with anti-PD-1

Group VI: Part C Dose Expansion - Cohort 2 Experimental Treatment 1 Intervention

Recommended Phase 2 dose and schedule of CRB-701, intravenous infusion over 30 mins

Group VII: Part C Dose Expansion - Cohort 1 Experimental Treatment 2 Interventions

Recommended Phase 2 dose and schedule of CRB-701, intravenous infusion over 30 mins followed by infusion with anti-PD-1

Group VIII: Part B Dose Optimization: CRB-701 low dose combined with anti-PD-1 Experimental Treatment 2 Interventions

Selected low dose of CRB-701, intravenous infusion over 30 mins followed by infusion with anti-PD-1

Group IX: Part B Dose Optimization: CRB-701 low dose Experimental Treatment 1 Intervention

Selected Low dose of CRB-701, intravenous infusion over 30 mins

Group X: Part B Dose Optimization: CRB-701 high dose combined with anti-PD-1 Experimental Treatment 2 Interventions

Selected high dose of CRB-701, intravenous infusion over 30 mins followed by infusion with anti-PD-1

Group XI: Part B Dose Optimization: CRB-701 High dose Experimental Treatment 1 Intervention

Selected high dose of CRB-701, intravenous infusion over 30 mins, dose schedule 1

Group XII: Part A Dose Escalation - CRB-701 Dose Level 4 Experimental Treatment 1 Intervention

CRB-701 Dose Level 4, intravenous infusion over 30 mins, dose schedule 1

Group XIII: Part A Dose Escalation - CRB-701 Dose Level 3 Experimental Treatment 1 Intervention

CRB-701 Dose Level 3, intravenous infusion over 30 mins, dose schedule 1

Group XIV: Part A Dose Escalation - CRB-701 Dose Level 2 Experimental Treatment 1 Intervention

CRB-701 Dose Level 2, intravenous infusion over 30 mins, Dose schedule 1

Group XV: Part A Dose Escalation - CRB-701 Dose Level 1 Experimental Treatment 1 Intervention

CRB-701 Dose level 1, intravenous infusion over 30 mins, Dose schedule 1

CRB-701 is already approved in United States for the following indications:

Approved in United States as CRB-701 for:

• Relapsed/Refractory Metastatic Cervical Cancer

Who Is Running the Clinical Trial?

Corbus Pharmaceuticals Inc.

Lead Sponsor

Trials

9

Recruited

1,800+

CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.

Industry Sponsor

Trials

19

Recruited

2,500+