Trials / Completed
CompletedNCT03658772
Grapiprant and Pembrolizumab in Patients With Advanced or Progressive MSS Colorectal Cancer
An Open-label, Single-arm, Phase 1b Study to Evaluate the Safety and Efficacy of Grapiprant (ARY-007) in Combination With Pembolizumab in Patients With Advanced or Progressive Microsatellite Stable (MSS) Colorectal Cancer (CRC)
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 54 (actual)
- Sponsor
- Arrys Therapeutics · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study will be conducted in adult participants diagnosed with any form of an advanced or progressive MSS CRC for which 1st and 2nd line standard therapy (at least one of which contained fluorouracil) is no longer effective or is intolerable. This is a phase 1b, multi-center, open label study designed to assess safety and tolerability of grapiprant in combination with pembrolizumab, to determine the recommended phase 2 dose (RP2D) with pembrolizumab, and to evaluate and characterize the PK of grapiprant alone and in combination with pembrolizumab. Disease response, pharmacodynamics, and response biomarkers will also be assessed.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | grapiprant | Cohort 1 will be treated for 1 week with oral grapiprant as a single agent, followed by 21-day combination treatment cycles of oral grapiprant in combination with IV pembrolizumab. |
| DRUG | grapiprant and pembrolizumab | Cohort 2 will be administered 21-day combination treatment cycles of oral grapiprant in combination with IV pembrolizumab. |
Timeline
- Start date
- 2018-09-20
- Primary completion
- 2023-03-07
- Completion
- 2023-03-07
- First posted
- 2018-09-05
- Last updated
- 2023-10-24
Locations
4 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03658772. Inclusion in this directory is not an endorsement.