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

Part of paid clinical trials in Grand Rapids, Michigan.

Sponsor
Constellation Pharmaceuticals
Study ID
NCT03525795
Phase
PHASE1
Status
Completed

Conditions

  • Advanced Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CPI-1205 — DRUG
    Administered orally
  • ipilimumab — DRUG
    Administered intravenously

Study Details

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.

Key Dates

Start date
Dec 14, 2017
Status verified
May 2022
Primary completion
Jun 12, 2019
Completion
Jun 12, 2019

Study Design

Enrollment
24 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: CPI-1205 Combination with ipilimumab

Primary Outcome Measure

Phase 1: Frequency of Dose-limiting toxicities (DLTs) [ Time Frame: 1 year ]

Locations (3)

FacilityCityStateZIPSite coordinators
START MidwestGrand RapidsMichigan49546-
The University of Texas - MD Anderson Cancer CenterHoustonTexas77030-
South Texas Oncology & HematologySan AntonioTexas78229-

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