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Treatment for advanced gastrointestinal cancers using MK-2870 with or without chemotherapy

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

Phase1; Phase2 Interventional Merck Sharp & Dohme LLC · NCT06428409

This study is testing whether a new drug called MK-2870, alone or with chemotherapy, can help people with advanced gastrointestinal cancers like colorectal, pancreatic, or biliary tract cancer feel better and improve their treatment outcomes.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment220 (estimated)
Ages18 Years and up
SexAll
SponsorMerck Sharp & Dohme LLC Industry-sponsored
Drugs / interventionssacituzumab
Locations55 sites (Los Angeles, California and 54 other locations)
Trial IDNCT06428409 on ClinicalTrials.gov

What this trial studies

This clinical study investigates the effectiveness of sacituzumab tirumotecan (MK-2870) alone or in combination with chemotherapy for patients with advanced or unresectable gastrointestinal cancers, specifically colorectal cancer, pancreatic ductal adenocarcinoma, and biliary tract cancer. The study aims to assess the safety and tolerability of the treatment, as well as the response rate of the cancer to the intervention. Participants will have previously received therapy for their cancer and must have recovered from any side effects before joining the study.

Who should consider this trial

Good fit: Ideal candidates include individuals with unresectable or metastatic colorectal cancer, advanced pancreatic ductal adenocarcinoma, or advanced biliary tract cancer who have previously undergone treatment.

Not a fit: Patients with severe eye disease or those who have had recent systemic anticancer therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat gastrointestinal cancers.

How similar studies have performed: Other studies have shown promise with similar approaches, but the specific combination of MK-2870 with chemotherapy is being explored in this novel context.

Eligibility criteria

Show full inclusion / exclusion 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:

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

Where this trial is running

Los Angeles, California and 54 other locations

+5 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Colorectal CancerPancreatic Ductal AdenocarcinomaBiliary Tract Cancer
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.