A Phase 1/2 Study to Evaluate the Safety and Efficacy of MK-2870 Monotherapy or in Combination With Other Anticancer Agents in Gastrointestinal Cancers

Status

Recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-508703-21-00

Acronym

MK-9999-02A

Enrollment

Registered

2024-07-08

Start date

2024-08-01

Completion date

Unknown

Last updated

2025-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal cancer (CRC), pancreatic ductal adenocarcinoma (PDAC), biliary tract cancer (BTC)

Brief summary

1. Number of Participants Who Experience a Dose-limiting Toxicity (DLT), 2. Number of Participants Who Experience One or More Adverse Events (AEs), 3. Number of Participants Who Discontinue Study Treatment Due to an AE, 4. Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Blinded Independent Central Review (BICR)

Detailed description

1. Duration of Response (DOR) per RECIST 1.1 as Assessed by BICR, 2. Progression-free Survival (PFS) per RECIST 1.1 as Assessed by BICR, 3. Overall Survival (OS)

Interventions

DRUG-

DRUGFLUOROURACIL

DRUGCALCIUM FOLINATE

DRUGPARACETAMOL

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion.

DRUGCISPLATIN

DRUGMK-2870

DRUGCALCIUM LEVOFOLINATE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
1. Number of Participants Who Experience a Dose-limiting Toxicity (DLT), 2. Number of Participants Who Experience One or More Adverse Events (AEs), 3. Number of Participants Who Discontinue Study Treatment Due to an AE, 4. Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Blinded Independent Central Review (BICR)	—

Secondary

Measure	Time frame
1. Duration of Response (DOR) per RECIST 1.1 as Assessed by BICR, 2. Progression-free Survival (PFS) per RECIST 1.1 as Assessed by BICR, 3. Overall Survival (OS)	—

Countries

Italy, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026