NCT03525795

ORIOn-E: A Study Evaluating CPI-1205 in Patients With Advanced Solid Tumors

A Phase 1 Study of CPI-1205 With Ipilimumab in Patients With Advanced Solid Tumors Followed by a Phase 2 Basket Study of CPI-1205 With Ipilimumab in Selected Tumor Types Previously Treated With PD-1 or PD-L1 Inhibitors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Constellation Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1/2, multi-center, open-label study of CPI-1205 + ipilimumab in patients with histologically or cytologically confirmed advanced solid tumors. This study is designed to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of CPI-1205 + ipilimumab in patients with advanced solid tumors. Patients in Phase 2 will be treated at the RP2D of CPI-1205 + ipilimumab. This study was stopped prior to proceeding to Phase 2; no patients were enrolled in Phase 2.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	CPI-1205	Administered orally
DRUG	ipilimumab	Administered intravenously

Timeline

• Start date: 2017-12-14
• Primary completion: 2019-06-12
• Completion: 2019-06-12
• First posted: 2018-05-16
• Last updated: 2022-05-18

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study