A Phase 1b/2 Study of BMS-813160 in Combination With Chemotherapy or Nivolumab in Patients With Advanced Solid Tumors
Description
Brief Summary
The purpose of this study is to evaluate the safety profile, tolerability, drug levels, drug
effects, and preliminary efficacy of BMS-813160 alone or in combination with either
chemotherapy or nivolumab or chemotherapy plus nivolumab in participants with metastatic
colorectal and pancreatic cancers.
Phase
N/AInclusion and Exclusion Criteria
- Must have metastatic colorectal or pancreatic cancer
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤1
- Ability to swallow pills or capsules
- Required to undergo mandatory pre and on-treatment biopsies
- Adequate marrow function
- Adequate other organ functions
- Ability to comply with study visits, treatment, procedures, pharmacokinetic (PK) and pharmacodynamic (PD) sample collection, and required study follow-up
- Histology other than adenocarcinoma (neuroendocrine or acinar cell)
- Suspected, known, or central nervous system (CNS) metastases (Imaging required only if participants are symptomatic)
- Active, known or suspected autoimmune disease
- Condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study treatment administration
- Interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected treatment-related pulmonary toxicity
- Prior treatment with cysteine-cysteine chemokine receptor 2 (CCR2) and/or cysteine-cysteine chemokine receptor 5 (CCR5) inhibitors, programmed death-1 receptor (PD-1), programmed death-ligand 1 [PD(L)-1] or cytotoxic T-lymphocyte antigen-4 (CTLA-4) antibodies
- History of allergy to study treatments or any of its components of the study arm that participant is enrolling Other protocol-defined inclusion/exclusion criteria apply
Sites
Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.
Presentado por
SC CTSI