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

Phase 1

Recruiting

• Conditions: Colorectal Cancer; Biliary Tract Cancer; Pancreatic Ductal Adenocarcinoma
• Interventions: Biological: Sacituzumab tirumotecan; Drug: Fluorouracil (5-FU); Drug: Cisplatin; Drug: Leucovorin (LV) or levoleucovorin; Biological: Pembrolizumab; Drug: Rescue medication; Drug: Supportive care measures

• Registration Number: NCT06428409
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-05-20
• Study First Submitted QC: 2024-05-20
• Study First Posted: 2024-05-24
• Study Start: 2024-06-20
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-18
• Last Update Posted: 2025-07-20
• Primary Completion: 2029-10-16
• Study Completion: 2029-10-16

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sacituzumab tirumotecan + Chemotherapy	Sacituzumab tirumotecan	Participants will receive sacituzumab tirumotecan in one of two dose levels and chemotherapy every 2 weeks (Day 1 and Day 15 of every 4-week cycle). Participants will continue to receive the treatment until the cancer gets worse or they don't tolerate treatment.
Sacituzumab tirumotecan + Chemotherapy	Fluorouracil (5-FU)	Participants will receive sacituzumab tirumotecan in one of two dose levels and chemotherapy every 2 weeks (Day 1 and Day 15 of every 4-week cycle). Participants will continue to receive the treatment until the cancer gets worse or they don't tolerate treatment.
Sacituzumab tirumotecan + Chemotherapy	Leucovorin (LV) or levoleucovorin	Participants will receive sacituzumab tirumotecan in one of two dose levels and chemotherapy every 2 weeks (Day 1 and Day 15 of every 4-week cycle). Participants will continue to receive the treatment until the cancer gets worse or they don't tolerate treatment.
Sacituzumab tirumotecan + Chemotherapy	Rescue medication	Participants will receive sacituzumab tirumotecan in one of two dose levels and chemotherapy every 2 weeks (Day 1 and Day 15 of every 4-week cycle). Participants will continue to receive the treatment until the cancer gets worse or they don't tolerate treatment.
Sacituzumab tirumotecan + Chemotherapy	Supportive care measures	Participants will receive sacituzumab tirumotecan in one of two dose levels and chemotherapy every 2 weeks (Day 1 and Day 15 of every 4-week cycle). Participants will continue to receive the treatment until the cancer gets worse or they don't tolerate treatment.
Sacituzumab tirumotecan	Sacituzumab tirumotecan	Participants will receive sacituzumab tirumotecan every 2 weeks (Day 1 and Day 15 of every 4-week cycle). Participants will continue to receive the treatment until the cancer gets worse or they don't tolerate treatment.
Sacituzumab tirumotecan	Rescue medication	Participants will receive sacituzumab tirumotecan every 2 weeks (Day 1 and Day 15 of every 4-week cycle). Participants will continue to receive the treatment until the cancer gets worse or they don't tolerate treatment.
Sacituzumab tirumotecan	Supportive care measures	Participants will receive sacituzumab tirumotecan every 2 weeks (Day 1 and Day 15 of every 4-week cycle). Participants will continue to receive the treatment until the cancer gets worse or they don't tolerate treatment.
Sacituzumab tirumotecan + Cisplatin + Pembrolizumab	Sacituzumab tirumotecan	Participants will receive sacituzumab tirumotecan in one of two dose levels on Day 1 and Day 8 of every 3-week cycle until the cancer gets worse or they don't tolerate treatment, cisplatin on Day 1 and Day 8 of each 3-week cycle for up to 8 cycles (up to approximately 6 months), and pembrolizumab on Day 1 of each 3-week cycle for up to approximately 2 years.
Sacituzumab tirumotecan + Cisplatin + Pembrolizumab	Cisplatin	Participants will receive sacituzumab tirumotecan in one of two dose levels on Day 1 and Day 8 of every 3-week cycle until the cancer gets worse or they don't tolerate treatment, cisplatin on Day 1 and Day 8 of each 3-week cycle for up to 8 cycles (up to approximately 6 months), and pembrolizumab on Day 1 of each 3-week cycle for up to approximately 2 years.
Sacituzumab tirumotecan + Cisplatin + Pembrolizumab	Pembrolizumab	Participants will receive sacituzumab tirumotecan in one of two dose levels on Day 1 and Day 8 of every 3-week cycle until the cancer gets worse or they don't tolerate treatment, cisplatin on Day 1 and Day 8 of each 3-week cycle for up to 8 cycles (up to approximately 6 months), and pembrolizumab on Day 1 of each 3-week cycle for up to approximately 2 years.

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Experience a Dose-limiting Toxicity (DLT)	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.
Number of Participants Who Experience One or More Adverse Events (AEs)	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.
Number of Participants who Discontinue Study Treatment due to an AE	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.
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Blinded Independent Central Review (BICR)	Up to approximately 63 months	ORR is defined as the percentage of participants with 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 Outcome Measures

Name	Time	Method
Duration of Response (DOR) per RECIST 1.1 as Assessed by BICR	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.
Progression-free Survival (PFS) per RECIST 1.1 as Assessed by BICR	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.
Overall Survival (OS)	Up to approximately 63 months	OS is the length of time from when the participant starts treatment until death from any cause

Trial Locations

Locations (55)

UCLA ( Site 0317); 🇺🇸 Los Angeles, California, United States

University of Colorado Anschutz Medical Campus ( Site 0299); 🇺🇸 Aurora, Colorado, United States

UCHealth Cherry Creek Medical Center ( Site 0326); 🇺🇸 Denver, Colorado, United States

UCHealth Highlands Ranch Hospital ( Site 0325); 🇺🇸 Highlands Ranch, Colorado, United States

Sibley Memorial Hospital ( Site 0310); 🇺🇸 Washington, District of Columbia, United States

University of Florida College of Medicine ( Site 0281); 🇺🇸 Gainesville, Florida, United States

Mount Sinai Cancer Center ( Site 0287); 🇺🇸 Miami Beach, Florida, United States

Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 0303); 🇺🇸 Marietta, Georgia, United States

Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0327); 🇺🇸 Mineola, New York, United States

Laura and Isaac Perlmutter Cancer Center at NYU Langone ( Site 0324); 🇺🇸 New York, New York, United States

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