NCT06265727 A Phase 1/2 Study to Investigate CRB-701 in Solid Tumors
| NCT ID | NCT06265727 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Corbus Pharmaceuticals Inc. |
| Condition | Solid Tumor, Adult |
| Study Type | INTERVENTIONAL |
| Enrollment | 348 participants |
| Start Date | 2024-04-01 |
| Primary Completion | 2027-01-16 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 348 participants in total. It began in 2024-04-01 with a primary completion date of 2027-01-16.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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%, uncontrolled diabetes mellitus or know diabetic neuropathy * Active ocular disease at baseline * Chronic severe liver disease or live cirrhosis * Interstitial lung disease or pneumonitis within 6 months on initiating treatment on study * Other significant cormorbidities.
Contact & Investigator
David Pinato, MD
PRINCIPAL INVESTIGATOR
Imperial College London
Frequently Asked Questions
Who can join the NCT06265727 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Solid Tumor, Adult. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06265727 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06265727 currently recruiting?
Yes, NCT06265727 is actively recruiting participants. Contact the research team at Clinical@Corbuspharma.com for enrollment information.
Where is the NCT06265727 trial being conducted?
This trial is being conducted at Birmingham, United States, Duarte, United States, San Diego, United States, San Francisco, United States and 11 additional locations.
Who is sponsoring the NCT06265727 clinical trial?
NCT06265727 is sponsored by Corbus Pharmaceuticals Inc.. The principal investigator is David Pinato, MD at Imperial College London. The trial plans to enroll 348 participants.