What is the Purpose of this Study?
Primary Objective: Part A: To evaluate the safety and tolerability and determine the MTD and PADR for CRB-601 administered as a monotherapy in patients with select relapsed/refractory solid tumors who have progressed after at least one line of therapy. Part B: To characterize the safety of CRB-601 in combination with cemiplimab with or without single-lesion, immune-priming SBRT. Part C: To evaluate the efficacy of CRB-601 (in terms of ORR) when administered within the PADR in combination with cemiplimab, with or without single-lesion, immune-priming SBRT. Secondary Objectives: Part A: 1. To further characterize the safety profile of CRB-601 at the MTD or PADR. 2. To characterize the PK profile of CRB-601 administered as a monotherapy. 3. To evaluate the immunogenicity of CRB-601, assessed by the incidence and persistence of ADAs following exposure to CRB-601, and its impact on the PK profile of CRB-601. 4. To evaluate the preliminary anti-tumor activity of CRB--601. Part B: 1. To characterize the PK profile of CRB-601 administered in combination with cemiplimab, with or without single-lesion, immune-priming SBRT. 2. To evaluate the immunogenicity of CRB-601 when used in combination with cemiplimab, with or without single-lesion, immune-priming SBRT, assessed by the incidence and persistence of ADAs following exposure to CRB-601, and its impact on the PK profile of CRB-601. 3. To evaluate the preliminary anti-tumor activity of CRB-601 administered in combination with cemiplimab, with or without single-lesion, immune-priming SBRT. Part C: 1. To evaluate the safety of CRB-601 administered in combination with cemiplimab, with or without single-lesion, immune-priming SBRT. To evaluate the immunogenicity of CRB-601, assessed by the presence of ADAs following exposure to CRB-601. 2. To evaluate the efficacy of CRB-601, administered in combination with cemiplimab, with or without single-lesion, immune-priming SBRT. 3. To evaluate the immunogenicity of CRB-601, assessed by the presence of ADAs following exposure to CRB--601. 4. To evaluate the PK profile of CRB-601 when administered in combination with cemiplimab, with or without single-lesion, immune-priming SBRT.
Eligibility
- * 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.
Where can I participate?
- CS Cancer at Cedars-Sinai Medical Center : Shannon Cyhan
- CS Cancer at The Angeles Clinic and Research Institute : Shannon Cyhan
More about this Clinical Trial
What is the full name of this clinical trial?
CRB-601-01: A Phase 1/2 Study to Investigate the Safety, Pharmacokinetics and Efficacy of CRB-601, a Monoclonal Antibody against Integrin av B8, in Patients with Advanced Solid Tumors