A Phase 1/2 Study to Investigate the Safety, Pharmacokinetics, and Efficacy of CRB-701, an Antibody-drug Conjugate Targeting Nectin-4, in Patients With Advanced Solid Tumors
Corbus Pharmaceuticals Inc.
Summary
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? 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. They will have blood tests, CT or MRI Scans, and other assessments to measure whether CRB-701 has an effect on tumors.
Description
This is a three-part open-label, Phase 1/2 clinical trial designed to evaluate the safety, PK, and efficacy of CRB-701 in participants with advanced solid tumors expressing nectin-4. Part A will include solid tumor types known to express nectin-4. Dose escalation will be guided by the Bayesian optimal interval (BOIN) design to determine the Maximum Tolerated Dose (MTD) of CRB-701. Four (4) dose groups are pre-determined. Dose escalation/de-escalation decisions are made based on the occurrence of DLT. Part B will evaluate two dose levels of CRB-701 alone and in combination with anti-PD-1 by u…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Confirmed diagnosis of select advanced or metastatic nectin-4 expressing solid tumors that have progressed having exhausted all appropriate lines of therapy or have no other standard therapy with proven clinical benefit. In Part C, HNSCC participants may enroll as first-line therapy. Exclusion Criteria: * Active of uncontrolled CNS metastases * History of solid tumors other than the diseases under study * History of and/or current cardiovascular events or conditions in the previous 6 months * Pre-existing \>/= Grade 2 neuropathy * Hemoglobin A1C (HbA1C) \>/= 8%, uncont…
Interventions
- DrugCRB-701
Nectin-4 targeted Antibody Drug Conjugate (ADC)
- DrugAnti-PD-1
checkpoint inhibitor
Locations (41)
- O'Neal Comprehensive Cancer Center at University of Alabama-BirminghamBirmingham, Alabama
- City of Hope Cancer CenterDuarte, California
- Moores Cancer Centre at UC San Diego HealthSan Diego, California
- Helen Diller Family Comprehensive Cancer Center - UCSFSan Francisco, California
- Rocky Mountain Cancer CentresDenver, Colorado
- Yale Cancer CenterNew Haven, Connecticut