NCT06603844 First-in-human Study of CRB-601-01 to Treat Patients With Advanced Solid Tumor.
| NCT ID | NCT06603844 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Corbus Pharmaceuticals Inc. |
| Condition | Solid Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 156 participants |
| Start Date | 2024-12-04 |
| Primary Completion | 2026-11-01 |
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 156 participants in total. It began in 2024-12-04 with a primary completion date of 2026-11-01.
⚠ 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 purpose of this study is to determine the safety, blood concentrations and treatment effect of CRB-601 in combination with immunotherapy 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. 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.
Eligibility Criteria
Inclusion Criteria: * Confirmed diagnosis of select locally advanced or metastatic solid tumors that have progressed after at least one line of therapy or have no other standard therapy with proven clinical benefit available. * Measurable disease on imaging as assessed by RECIST 1.1 Eastern Cooperative Oncology Group (ECOG) performance status (PS) greater or equal to 2. * Life expectancy of more than 12 weeks. * Adequate hematologic and end-organ function. Exclusion Criteria: * History of solid tumor malignancies other than the disease under study within 3 years of study enrollment * History of and/or current cardiovascular events or conditions * Chronic severe liver disease or liver cirrhosis * Systemic autoimmune disease * Active thrombophlebitis, thromboembolism or hypercoagulability states or uncontrolled bleeding or diabetes. * Interstitial lung disease within 6 months of study enrollment. * Active or persistent infection * Other conditions that in the opinion of the Investigator would compromise the outcomes of the study.
Contact & Investigator
Jeff Clarke, MD
PRINCIPAL INVESTIGATOR
Duke University, NC, USA
Frequently Asked Questions
Who can join the NCT06603844 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Solid Tumor. 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 NCT06603844 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 NCT06603844 currently recruiting?
Yes, NCT06603844 is actively recruiting participants. Contact the research team at Ian.Hodgson@corbuspharma.com for enrollment information.
Where is the NCT06603844 trial being conducted?
This trial is being conducted at Birmingham, United States, Tucson, United States, Tucson, United States, La Jolla, United States and 11 additional locations.
Who is sponsoring the NCT06603844 clinical trial?
NCT06603844 is sponsored by Corbus Pharmaceuticals Inc.. The principal investigator is Jeff Clarke, MD at Duke University, NC, USA. The trial plans to enroll 156 participants.