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RecruitingLast updated: 7 July 2026

MK-9999-02A: Testing whether targeted treatment with sacituzumab tirumotecan, given alone or with other treatments, can treat advanced bowel cancer, pancreatic cancer, or biliary tract cancerA 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 purpose

Medical clipboardCancer treatment

Tumor type

Multi-Cancer Multi-Cancer

Age

People18+

Trial acronym

MK-9999-02A

Clinical summary

Summary

Researchers are studying whether a targeted medicine called sacituzumab tirumotecan (also known as MK-2870), used alone or with other treatments, can treat certain gastrointestinal (GI) cancers.

The cancers being studied are either advanced or metastatic (have spread to other parts of the body) or unresectable (cancer cannot be removed with surgery).

The goals of this study are to learn:

  • How safe the treatment is and how well people tolerate it
  • How many people have their cancer respond to treatment (shrink or go away)

You may be eligible if you have one of the following cancers:

  • Unresectable or metastatic colorectal cancer, and have received prior treatment
  • Advanced or metastatic pancreatic cancer and have received prior treatment
  • Advanced and/or unresectable biliary tract cancer (you may or may not have received prior treatment)

Eligible participants will be allocated to one of three treatment groups.

  • Arm 1: Sacituzumab tirumotecan + chemotherapy
  • Arm 2: Sacituzumab tirumotecan alone
  • Arm 3: Sacituzumab tirumotecan + cisplatin chemotherapy + pembrolizumab immunotherapy

 

In all arms, participants will continue to receive the treatment until the cancer gets worse or they don't tolerate treatment.

Conditions

This trial is treating people with advanced or metastatic colorectal cancer, pancreatic ductal adenocarcinoma, or biliary tract cancer

Eligibility

Inclusion

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

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 (ILD) that required steroids, has current pneumonitis/ILD, or has suspected ILD or pneumonitis that cannot be ruled out by standard diagnostic assessments at Screening

Inclusion

  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
  • Your cancer has not spread to other parts of the body, but it is not possible to perform surgery to remove it (unresectable).

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov, EU Clinical Trials Register *. View further details about this trial on the registry via the links below:

  • NCT06428409 *
  • 2023-508703-21 *
  • MK-9999-U02; U1111-1298-8273; JRCT2031240178; 9999-02A

Trial sponsor

Merck Sharp & Dohme LLC

Scientific Title

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

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