Phase 1/2 Basket Study of MK-2870 in GI Cancers

Phase 1

Recruiting

Conditions: Colorectal cancer (CRC), pancreatic ductal adenocarcinoma (PDAC), biliary tract cancer (BTC)
MedDRA version: 20.0Level: LLTClassification code: 10028982Term: Neoplasm biliary tract Class: 10029104
MedDRA version: 20.0Level: PTClassification code: 10073364Term: Ductal adenocarcinoma of pancreas Class: 100000004864
MedDRA version: 21.0Level: LLTClassification code: 10010029Term: Colorectal cancer NOS Class: 10029104
Therapeutic area: Diseases [C] - Neoplasms [C04]

Registration Number: CTIS2023-508703-21-00

Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 139

Inclusion Criteria

1.Has one of the following cancers: •Unresectable or metastatic colorectal cancer •Advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) •Advanced and/or unresectable biliary tract cancer (BTC), 2.Has received one previous treatment for the cancer (colorectal cancer, PDAC); has received one or two previous treatments for BTC, 3.Has recovered from any side effects due to previous cancer treatment

Exclusion Criteria

1.History of severe eye disease, 2.Received prior treatment with a trophoblast cell surface antigen 2 (TROP2)-targeted antibody-drug conjugate (ADC)., 3.Received prior systemic anticancer therapy including investigational agents within 4 weeks before starting study intervention.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 1. To evaluate the safety and tolerability of MK-2870 monotherapy or in combination with other anticancer agents<br>2. To evaluate the confirmed ORR per RECIST 1.1 as assessed by BICR;Secondary Objective: 1.To evaluate the DOR per RECIST 1.1 as assessed by BICR, 2.To evaluate PFS per RECIST 1.1 as assessed by BICR, 3.To evaluate OS;Primary end point(s): 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 Adverse Event (AE):

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):1.Duration of Response (DOR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Blinded Independent Central Review (BICR);Secondary end point(s):2.Progression-free Survival (PFS) per RECIST 1.1 as Assessed by BICR;Secondary end point(s):3.Overall Survival (OS)