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Clinical Trials List

Protocol NumberMK-9999-02A
NCT Number(ClinicalTrials.gov Identfier)NCT06428409
Active

2024-05-17 - 2030-12-31

Phase I/II

Recruiting5

ICD-10C18.8

Malignant neoplasm of overlapping sites of colon

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9153.8

Malignant neoplasm of other specified sites of large intestine

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

  • Trial Applicant

    Merck Sharp & Dohme (I.A.) LLC

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/06/17

Investigators and Locations

Principal Investigator Ming-Huang Chen Division of Hematology & Oncology
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chih-Hung Hsu Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Jen-Shi Chen Division of Hematology & Oncology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Li-Yuan Bai Division of Hematology & Oncology
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chia-Jui Yen
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Colorectal Cancer

Objectives

Primary Objectives: 1. To evaluate the safety and tolerability of MK-2870 as monotherapy or in combination with other anticancer drugs. 2. To evaluate the objective response rate (ORR) confirmed by blinded independent central review (BICR) according to the RECIST 1.1 criteria for response to solid tumors, version 1.1. Secondary Objectives: 1. To evaluate the duration of response (DOR) as assessed by BICR according to RECIST 1.1. 2. To evaluate progression-free survival (PFS) as assessed by BICR according to RECIST 1.1. 3. To evaluate overall survival (OS).

Test Drug

Injectables

Injectables

Injectables

Injectables

Injectables

Active Ingredient

Recombinant humanized IgG1 anti-TROP2 monoclonal antibody conjugated to KL610023
calcium folinate hydrate
fluorouracil
Pembrolizumab
CISPLATIN

Dosage Form

270
270
270
270
270

Dosage

200 mg/ vial
100 mg/ml
50 mg/ml

Endpoints

-

Inclution Criteria

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

Has one of the following cancers:

Unresectable or metastatic colorectal cancer and has received prior therapy for the cancer
Advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) and has received prior therapy for the cancer
Advanced and/or unresectable biliary tract cancer (BTC) and has received prior therapy for the cancer
Advanced and/or unresectable BTC and has not received prior therapy for the cancer
For participants who have received prior therapy for cancer: Has recovered from any side effects due to previous cancer treatment

Exclusion Criteria

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

History of severe eye disease
For participants who have received prior therapy for cancer: Received prior systemic anticancer therapy including investigational agents within 4 weeks before starting study intervention
History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease

The Estimated Number of Participants

  • Taiwan

    40 participants

  • Global

    180 participants

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