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

JRCT ID: jRCT2031240178

Registered date:21/06/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Colorectal Cancer, Pancreatic Ductal Carcinoma, Biliary Tract Cancer
• Date of first enrollment: 01/08/2024
• Target sample size: 10
• Countries of recruitment: Australia,Japan,South Korea,Japan,Taiwan,Japan,China,Japan,Italy,Japan,Spain,Japan,Turkey,Japan,Switzerland,Japan,United Kingdom,Japan,Chile,Japan,Canada,Japan,USA,Japan
• Study type: Interventional

Intervention(s)

Combination arm: MK-2870 in one of two dose levels and chemotherapy (Fluorouracil (5-FU) and Leucovorin (LV) or levoleucovorin) by intravenous (IV) infusion, every 2 weeks.
Monotherapy arm: MK-2870 every 2 weeks via IV infusion.

Outcome(s)

Primary Outcome

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

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Has one of the following cancers:
-Unresectable or metastatic colorectal cancer
-Advanced or metastatic pancreatic ductal adenocarcinoma
-Advanced and/or unresectable biliary tract cancer
Has received prior therapy for the cancer
Has recovered from any side effects due to previous cancer treatment

Exclude criteria

History of severe eye disease
Received prior systemic anticancer therapy including investigational agents within 4 weeks before starting study intervention.

Related Information

• Primary Sponsor: Fujita Tomoko
• Secondary ID(s): NCT06428409