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NCT Number: NCT06428409

A Clinical Study of MK-2870 Alone or With Other Treatments to Treat Gastrointestinal Cancers (MK-9999-02A)

Researchers want to learn if sacituzumab tirumotecan (MK-2870) alone or with other treatments can treat certain gastrointestinal (GI) cancers. The GI cancers being studied are either advanced (the cancer has spread to other parts of the body), or unresectable (the cancer cannot be removed with surgery). The goals of this study are to learn:

* About the safety of sacituzumab tirumotecan alone or with other treatments and if people tolerate it * How many people have the cancer respond (get smaller or go away) to treatment

Recruiting

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Key information

Conditions

Colorectal Cancer Biliary Tract Cancer Biliary Tract Diseases Biliary Tract Neoplasms Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Pancreatic Ductal Adenocarcinoma Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Westmead Hospital ( Site 0003), Westmead, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 (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

Treatment and study plan

Sacituzumab tirumotecan

Biological

Given by IV infusion.

Other names: MK-2870, SKB264

Fluorouracil (5-FU)

Drug

5-FU is administered by IV infusion over 46 to 48 hours every 2 weeks.

Leucovorin (LV) or levoleucovorin

Drug

LV or levoleucovorin is administered by IV infusion every 2 weeks.

Rescue medication

Drug

Participants receive the following rescue medications, per approved product label, as premedication to study treatment to prevent hypersensitivity and/or infusion reactions: diphenhydramine (or equivalent histamine-1 [H1] receptor antagonist), H2 receptor antagonist, acetaminophen or equivalent, and dexamethasone or equivalent infusion. A steroid mouthwash (dexamethasone or equivalent) will be given as prophylaxis for stomatitis/oral mucositis.

Supportive care measures

Drug

Participants are allowed to take supportive care measures for the management of adverse events associated with study intervention at the discretion of the investigator. Supportive care measures may include but are not limited to antidiarrheal agents and antiemetic agents. Artificial tear drops or gel may be given as supportive care for Ocular Surface Toxicity.

Cisplatin

Drug

Given by IV infusion.

Other names: PLATINOL®

Pembrolizumab

Biological

Given by IV infusion.

Other names: MK-3475, KEYTRUDA®

Primary outcomes

  1. Number of Participants Who Experience a Dose-limiting Toxicity (DLT)

    Time frame: Up to approximately 4 weeks

    A DLT is a medical problem related to the study medicine that prevents giving participants a higher dose or may prevent giving the participant the same dose. The number of participants who experience a DLT will be reported.

  2. Number of Participants Who Experience One or More Adverse Events (AEs)

    Time frame: Up to approximately 63 months

    An AE is a health problem that happens or worsens during the study. The number of participants who have an AE during the study will be reported.

  3. Number of Participants who Discontinue Study Treatment due to an AE

    Time frame: Up to approximately 63 months

    An AE is a health problem that happens or worsens during a study. The number of participants who stop study treatment will be reported.

  4. Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Blinded Independent Central Review (BICR)

    Time frame: Up to approximately 63 months

    ORR is defined as the percentage of participants with confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.

Secondary outcomes

  1. Duration of Response (DOR) per RECIST 1.1 as Assessed by BICR

    Time frame: Up to approximately 63 months

    For participants who demonstrate a confirmed Complete Response or Partial Response, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by BICR will be presented.

  2. Progression-free Survival (PFS) per RECIST 1.1 as Assessed by BICR

    Time frame: Up to approximately 63 months

    PFS is defined as the time from start of study treatment to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. According to RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by BICR will be presented.

  3. Overall Survival (OS)

    Time frame: Up to approximately 63 months

    OS is the length of time from when the participant starts treatment until death from any cause

Study contacts

Contact information is provided by the study sponsor or research team.

Toll Free Number

CONTACT

[email protected]

1-888-577-8839

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
May 24, 2024
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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