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grapiprant

Phase 1

Microsatellite Stable Colorectal Cancer | Small molecule | Oncology |Merck & Company, Inc.|Last Updated: Oct 24, 2023

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDBiomarker
Total Trials1
Total Enrollment54

FDA Designations

No designations recorded

Clinical trial landscape

grapiprant · 1 trial · 1 indication

Phase 1 1
NCT03658772Grapiprant and Pembrolizumab in Patients With Advanced or Progressive MSS Colorectal CancerMicrosatellite Stable Colorectal Cancer
COMPLETED54 Analytics
PHASE1COMPLETED
Grapiprant and Pembrolizumab in Patients With Advanced or Progressive MSS Colorectal Cancer
Microsatellite Stable Colorectal CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety and tolerability of grapiprant alone and in combination with pembrolizumab
Up to 90 days after the end of treatment (average of 7 months)

Number of incidence, severity, and duration of treatment emergent adverse events using CTCAE v5.0

Define the recommended phase 2 dose (RP2D) of grapiprant combined with pembrolizumab
Through Cycle 1 (21 days)

Number, incidence and severity of treatment related adverse events as assessed by CTCAE 5.0

Secondary Endpoints

Overall Response Rate (ORR)
7 months
Duration of Response (DOR)
7 months
Progression -free survival (PFS)
Up to 12 months
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cohort 1EXPERIMENTALSingle Agent run-in with grapiprant and then combination treatment of grapiprant and pembrolizumab.
Cohort 2EXPERIMENTALParticipants will be treated with grapiprant in combination with pembrolizumab.

Interventions

NameTypeDescription
grapiprantDRUGCohort 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.
grapiprant and pembrolizumabDRUGCohort 2 will be administered 21-day combination treatment cycles of oral grapiprant in combination with IV pembrolizumab.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites4

Key Inclusion Criteria: * Male and female adult patients 18 years of age or older on day of signing informed consent. * Patients must have a histologically confirmed advanced, metastatic, or progressive Microsatellite Stable (MSS) Colorectal Cancer (CRC) per institutional standards. * Patient has r...

Countries:United States
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Frequently asked questions about grapiprant

What is grapiprant used for in microsatellite stable colorectal cancer?

Grapiprant is an investigational small molecule being studied for the treatment of microsatellite stable colorectal cancer. It is being evaluated in combination with pembrolizumab in patients with advanced or progressive MSS colorectal cancer. The drug is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.

What does grapiprant target?

Grapiprant is a small molecule that targets the EP4 receptor, a subtype of the prostaglandin E2 receptor. By inhibiting this receptor, grapiprant may modulate the tumor microenvironment and enhance anti-tumor immune responses. This mechanism is being explored in the context of microsatellite stable colorectal cancer, where it is combined with pembrolizumab.

Who makes grapiprant?

Grapiprant is being developed by Merck & Company, Inc., a global pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. Merck is conducting clinical research to evaluate grapiprant's safety and efficacy in patients with microsatellite stable colorectal cancer.

What phase is grapiprant in?

Grapiprant is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies for any use. The ongoing research is focused on assessing its safety, tolerability, and preliminary efficacy in patients with advanced or progressive microsatellite stable colorectal cancer.

What clinical trials is grapiprant in?

Grapiprant has been studied in one completed Phase 1 clinical trial, identified as NCT03658772. This trial, titled "Grapiprant and Pembrolizumab in Patients With Advanced or Progressive MSS Colorectal Cancer," enrolled 54 participants in the United States. The study was controlled but not randomized or double-blinded, and it included biomarker-selected patients.

Is grapiprant the same as any other drug?

Grapiprant is not known to have alternative names. It is a distinct investigational compound developed by Merck & Company, Inc. In clinical trials, it is being studied as a combination therapy with pembrolizumab, an immune checkpoint inhibitor, for the treatment of microsatellite stable colorectal cancer.