Phase Ib Study of CBP-1019 in Combination With FOLFOX +/- Bevacizumab, Pembrolizumab, or Enzalutamide for Metastatic TRPV6-overexpressing Solid Tumors of Epithelial Origin
M.D. Anderson Cancer Center
Summary
An open-label, Phase Ib dose escalation and dose expansion clinical trial evaluating the safety and efficacy of CBP-1019 combinations in patients with solid tumors of epithelial origin.
Description
Primary Objectives: To determine the safety and tolerability of CBP-1019 combinations (Regimen A: CBP-1019 plus FOLFOX; Regimen B: CBP-1019 plus FOLFOX with bevacizumab; Regimen C: CBP-1019 plus pembrolizumab; and Regimen D: CBP-1019 plus enzalutamide) in metastatic solid tumors of epithelial origin. To determine the ORR of CBP-1019 combinations in selected metastatic solid tumors of epithelial origin. Secondary Objective: To evaluate other indicators of the antitumor activity of CBP-1019 combinations. Exploratory Objectives: To explore potential biomarkers associated with response/resis…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria 1. Patients must have histologically or cytologically confirmed malignancy of epithelial origin other than ovarian cancer that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective. Patients must have received at least one prior line of systemic standard therapy, and have either disease progression or intolerable toxicity after standard treatment. 2. In the dose expansion, Regimen A will enroll patients with metastatic pancreatic cancer with concurrent oxaliplatin and irinotecan-free interval ≥4 months (…
Interventions
- DrugCBP-1019
Given by vein (IV)
- DrugOxaliplatin
Given by vein (IV)
- DrugLeucovorin
Given by vein (IV)
- Drug5-FLUOROURACIL
Given by vein (IV)
- DrugBevacizumab
Given by vein (IV)
- DrugPembrolizumab
Given by vein (IV)
- DrugEnzalutamide
Given by mouth
Location
- MD Anderson Cancer CenterHouston, Texas