NCT03113188

CBP501, Cisplatin and Nivolumab in Advanced Refractory Tumors

Phase 1b Clinical Study of CBP501, Cisplatin and Nivolumab Administered Every 3 Weeks in Patients With Advanced Refractory Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: CanBas Co. Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, open-label, phase 1b study of CBP501/cisplatin/nivolumab combination administered once every 21 days to patients with advanced solid tumors.

Detailed description

Multicenter, open-label, phase 1b study of CBP501/cisplatin/nivolumab combination administered once every 21 days to patients with advanced solid tumors. The study will be conducted in two parts. The first part of the study involves dose-escalation, in which successive cohorts of three patients (expanded up to six patients in the event of a dose-limiting toxicity (DLT) or safety concerns) will receive escalating doses of CBP501 and/or cisplatin until the maximum tolerated dose (MTD) is reached or RP2D defined, based on tolerability observed during the first 21 days of treatment and safety review of all available information by the Safety Monitoring Committee. The second part of the study involves treatment of expansion cohorts of 10 evaluable patients each in pretreated metastatic exocrine pancreatic cancer and in microsatellite stable colorectal cancer to confirm the tolerability of treatment at the RP2D and evaluate preliminary evidence of anti-tumor activity in these indications.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	CBP501	CBP501, CDDP plus Nivolumab

Timeline

• Start date: 2017-10-25
• Primary completion: 2021-02-15
• Completion: 2021-02-15
• First posted: 2017-04-13
• Last updated: 2021-03-10

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study