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Monoclonal Antibodies

MK-2870 + Chemotherapy for Gastrointestinal Cancer

Phase 1 & 2
Recruiting
Research Sponsored by Merck Sharp & Dohme LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Unresectable or metastatic colorectal cancer
Advanced or metastatic pancreatic ductal adenocarcinoma (PDAC)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 53 months
Awards & highlights

Summary

This trial aims to see if a drug called sacituzumab tirumotecan (MK-2870) alone or in combination with chemotherapy can effectively treat specific gastrointestinal (GI) cancers.

Who is the study for?
This trial is for adults with advanced or inoperable gastrointestinal cancers, including colorectal, biliary tract, and pancreatic cancers. Participants must have had prior cancer therapy and recovered from its side effects.
What is being tested?
The study tests sacituzumab tirumotecan (MK-2870) alone or combined with chemotherapy (5-FU and leucovorin). It aims to assess the treatment's safety, tolerability, and effectiveness in shrinking or eliminating tumors.
What are the potential side effects?
Potential side effects may include reactions at the infusion site, nausea, diarrhea, low blood counts leading to increased infection risk or bleeding tendencies, fatigue, and liver function changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My colorectal cancer cannot be removed by surgery or has spread.
Select...
My cancer is advanced pancreatic cancer.
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My biliary tract cancer cannot be removed by surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 53 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 53 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants Who Experience One or More Adverse Events (AEs)
Number of Participants Who Experience a Dose-limiting Toxicity (DLT)
Number of Participants who Discontinue Study Medication due to an AE
+1 more
Secondary study objectives
Duration of Response (DOR) per RECIST 1.1 as Assessed by BICR
Overall Survival (OS)
Progression-free Survival (PFS) per RECIST 1.1 as Assessed by BICR

Trial Design

2Treatment groups
Experimental Treatment
Group I: Sacituzumab tirumotecan + ChemotherapyExperimental Treatment5 Interventions
Participants will receive sacituzumab tirumotecan in one of two dose levels and chemotherapy by intravenous (IV) infusion, every 2 weeks. Participants will continue to receive the treatment until the cancer gets worse or they don't tolerate treatment.
Group II: Sacituzumab tirumotecanExperimental Treatment3 Interventions
Participants will receive sacituzumab tirumotecan every 2 weeks via IV infusion. Participants will continue to receive the treatment until the cancer gets worse or they don't tolerate the treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rescue medication
2012
Completed Phase 3
~3860
Fluorouracil (5-FU)
2014
Completed Phase 2
~300

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Who is running the clinical trial?

Merck Sharp & Dohme LLCLead Sponsor
3,950 Previous Clinical Trials
5,174,853 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,834 Previous Clinical Trials
8,079,650 Total Patients Enrolled
~87 spots leftby Dec 2028
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