What is CRB-701 studying for advanced solid tumors?

CRB-701 is being studied to find a safe and effective dose for treating advanced solid tumors that express nectin-4. The study aims to understand how CRB-701 works alone or with another drug called anti-PD-1. This research is sponsored by Corbus Pharmaceuticals Inc. and seeks to improve treatment options for patients with these cancers.

Who may be eligible for this solid tumor clinical trial?

Adults 18 years and older with advanced or metastatic solid tumors expressing nectin-4 may be eligible. Participants must have exhausted standard therapies or have no other options. Both men and women can join. Participants should not have active brain metastases or recent serious heart conditions. Please review eligibility criteria for more details.

Is there any cost to participate in this solid tumor clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel and other expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any out-of-pocket costs.

Actively Recruiting

Phase 1

Phase 2

Age: 18Years +

All Genders

ID06265727

A Phase 12 Study to Investigate the Safety, Pharmacokinetics, and Efficacy of CRB-701, an Antibody-drug Conjugate Targeting Nectin-4, in Patients With Advanced Solid Tumors

Led by Corbus Pharmaceuticals Inc. · Updated on 2026-01-08

348

Participants Needed

Research Sites

1 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are investigating CRB-701, an antibody-drug conjugate targeting nectin-4, in adult patients with advanced solid tumors that express this protein. This three-part, open-label Phase 12 trial aims to determine a safe and effective dose of CRB-701 and to understand which cancers might respond to this treatment. The study explores safety, pharmacokinetics, and efficacy to guide future cancer therapies. Participants will receive CRB-701 through intravenous infusion over 30 minutes. The trial includes several dosing groups that range from dose escalation to dose optimization, sometimes combined with an anti-PD-1 drug. Part A focuses on escalating doses to find the maximum tolerated dose, Part B tests dose levels alone or with anti-PD-1 to optimize treatment, and Part C explores the recommended dose in multiple tumor cohorts. During the study, participants will attend clinic visits for infusions and undergo blood tests, CT or MRI scans, and other assessments to monitor tumor response and safety. Researchers will measure the safety, tolerability, and objective response rate to evaluate the treatments effect on tumors over periods ranging from 21 days to up to 6 months. The total study duration and monitoring will capture data on efficacy and side effects to support further research.

CONDITIONS

Brief Title

A Phase 1/2 Study to Investigate CRB-701 in Solid Tumors

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Confirmed diagnosis of select advanced or metastatic nectin-4 expressing solid tumors
Disease progressed after all appropriate therapies or no standard therapy with proven benefit remains
Participants with head and neck squamous cell carcinoma (HNSCC) may enroll as first-line therapy in Part C
Adults aged 18 years and older

You will not qualify if you...

Active or uncontrolled central nervous system metastases
History of solid tumors other than those under study
Cardiovascular events or conditions within the previous 6 months
Pre-existing neuropathy of grade 2 or higher
Hemoglobin A1C ≥ 8%, uncontrolled diabetes, or known diabetic neuropathy
Active ocular disease at baseline
Chronic severe liver disease or liver cirrhosis
Interstitial lung disease or pneumonitis within 6 months prior to treatment
Other significant comorbidities

Research Team

Ian Hodgson, PhD

Rodney Carter, BSc

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