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

NCT06428409 | Recruiting Phase 1 FDA Drug

• 5 other identifiers: 9999-02AMK-9999-02A2023-508703-21-00U1111-1298-8273jRCT2031240178
• Study Type: interventional
• Target: 220
• Locations: 13 countries
• Sites: 55

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

Conditions

Biliary Tract Cancer; Colorectal Cancer; Pancreatic Ductal Adenocarcinoma

Outcome Measures

Primary Outcomes (4)

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

  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.

  Up to approximately 4 weeks

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

  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.

  Up to approximately 63 months

• Number of Participants who Discontinue Study Treatment due to an AE

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

  Up to approximately 63 months

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

  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.

  Up to approximately 63 months

Secondary Outcomes (3)

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

  Up to approximately 63 months

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

  Up to approximately 63 months

• Overall Survival (OS)

  Up to approximately 63 months

Study Arms (3)

Sacituzumab tirumotecan + Chemotherapy

EXPERIMENTAL

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.

Biological: Sacituzumab tirumotecan; Drug: Fluorouracil (5-FU); Drug: Leucovorin (LV) or levoleucovorin; Drug: Rescue medication; Drug: Supportive care measures

Sacituzumab tirumotecan

EXPERIMENTAL

Participants will receive sacituzumab tirumotecan in one of two dose levels 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.

Biological: Sacituzumab tirumotecan; Drug: Rescue medication; Drug: Supportive care measures

Sacituzumab tirumotecan + Cisplatin + Pembrolizumab

EXPERIMENTAL

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.

Biological: Sacituzumab tirumotecan; Drug: Rescue medication; Drug: Supportive care measures; Drug: Cisplatin; Biological: Pembrolizumab

Interventions

Sacituzumab tirumotecan BIOLOGICAL

Given by IV infusion.

Also known as: MK-2870, SKB264

Sacituzumab tirumotecan; Sacituzumab tirumotecan + Chemotherapy; Sacituzumab tirumotecan + Cisplatin + Pembrolizumab

Fluorouracil (5-FU) DRUG

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

Sacituzumab tirumotecan + Chemotherapy

Leucovorin (LV) or levoleucovorin DRUG

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

Sacituzumab tirumotecan + Chemotherapy

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.

Sacituzumab tirumotecan; Sacituzumab tirumotecan + Chemotherapy; Sacituzumab tirumotecan + Cisplatin + Pembrolizumab

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.

Sacituzumab tirumotecan; Sacituzumab tirumotecan + Chemotherapy; Sacituzumab tirumotecan + Cisplatin + Pembrolizumab

Cisplatin DRUG

Given by IV infusion.

Also known as: PLATINOL®

Sacituzumab tirumotecan + Cisplatin + Pembrolizumab

Pembrolizumab BIOLOGICAL

Given by IV infusion.

Also known as: MK-3475, KEYTRUDA®

Sacituzumab tirumotecan + Cisplatin + Pembrolizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (55)

UCLA ( Site 0317)

Los Angeles, California, 90095, United States

RECRUITING

University of Colorado Anschutz Medical Campus ( Site 0299)

Aurora, Colorado, 80045, United States

RECRUITING

University of Colorado Anschutz Medical Campus ( Site 0325)

Aurora, Colorado, 80045, United States

RECRUITING

University of Colorado Anschutz Medical Campus ( Site 0326)

Aurora, Colorado, 80045, United States

RECRUITING

Sibley Memorial Hospital ( Site 0310)

Washington D.C., District of Columbia, 20016, United States

RECRUITING

University of Florida College of Medicine ( Site 0281)

Gainesville, Florida, 32610, United States

RECRUITING

Mount Sinai Cancer Center ( Site 0287)

Miami Beach, Florida, 33140, United States

RECRUITING

Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 0303)

Marietta, Georgia, 30060, United States

COMPLETED

Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0327)

Mineola, New York, 11501, United States

RECRUITING

Laura and Isaac Perlmutter Cancer Center at NYU Langone ( Site 0324)

New York, New York, 10016, United States

RECRUITING

University of Texas MD Anderson Cancer Center ( Site 0316)

Houston, Texas, 77030, United States

RECRUITING

Oncology and Hematology Associates of Southwest Virginia (BRCC) ( Site 0295)

Roanoke, Virginia, 24014, United States

RECRUITING

University Hospital and UW Health Clinics-Carbone Cancer Center ( Site 0293)

Madison, Wisconsin, 53792, United States

RECRUITING

Westmead Hospital ( Site 0003)

Westmead, New South Wales, 2145, Australia

RECRUITING

Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Site 0001)

Brisbane, Queensland, 4029, Australia

RECRUITING

Epworth Freemasons ( Site 0005)

East Melbourne, Victoria, 3002, Australia

RECRUITING

Frankston Hospital-Oncology and Haematology ( Site 0004)

Frankston, Victoria, 3199, Australia

RECRUITING

One Clinical Research ( Site 0002)

Nedlands, Western Australia, 6009, Australia

RECRUITING

The Ottawa Hospital Cancer Centre ( Site 0027)

Ottawa, Ontario, K1H 8L6, Canada

RECRUITING

Centre Hospitalier de l'Université de Montréal-Unit for Innovative Therapies ( Site 0022)

Montreal, Quebec, H2X 0A9, Canada

RECRUITING

McGill University Health Centre ( Site 0023)

Montreal, Quebec, H4A 3J1, Canada

RECRUITING

FALP-UIDO ( Site 0041)

Providencia, Region M. de Santiago, 7500921, Chile

RECRUITING

Clínica UC San Carlos de Apoquindo ( Site 0043)

Santiago, Region M. de Santiago, 7620002, Chile

RECRUITING

Bradfordhill-Clinical Area ( Site 0047)

Santiago, Region M. de Santiago, 8420383, Chile

RECRUITING

James Lind Centro de Investigacion del Cancer ( Site 0048)

Temuco, Región de la Araucanía, 4800827, Chile

RECRUITING

Beijing Cancer hospital-Digestive Oncology ( Site 0061)

Beijing, Beijing Municipality, 100142, China

RECRUITING

The 900th Hospital of the Joint Logistics Support Force of the Chinese People's Liberation Army ( Site 0063)

Fuzhou, Fujian, 350025, China

RECRUITING

Wuhan Union Hospital Cancer Center. ( Site 0064)

Wuhan, Hubei, 430024, China

RECRUITING

Hunan Cancer Hospital-intervention department ( Site 0066)

Changsha, Hunan, 410013, China

RECRUITING

Renji Hospital Shanghai Jiao Tong University School of Medicine-Oncology Department ( Site 0067)

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

West China Hospital, Sichuan University ( Site 0068)

Chengdu, Sichuan, 610041, China

RECRUITING

Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 0101)

Milan, Lombardy, 20133, Italy

RECRUITING

ASST Grande Ospedale Metropolitano Niguarda ( Site 0102)

Milan, Lombardy, 20162, Italy

RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 0103)

Roma, 00168, Italy

RECRUITING

National Cancer Center Hospital East ( Site 0121)

Kashiwa, Chiba, 277-8577, Japan

RECRUITING

Kanagawa Cancer Center ( Site 0122)

Yokohama, Kanagawa, 241-8515, Japan

RECRUITING

Seoul National University Hospital ( Site 0161)

Seoul, 03080, South Korea

RECRUITING

Severance Hospital, Yonsei University Health System ( Site 0164)

Seoul, 03722, South Korea

RECRUITING

Asan Medical Center ( Site 0163)

Seoul, 05505, South Korea

RECRUITING

Samsung Medical Center ( Site 0162)

Seoul, 06351, South Korea

RECRUITING

HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-ONCOLOGY ( Site 0183)

Madrid, Madrid, Comunidad de, 28009, Spain

RECRUITING

Hospital Universitario Central de Asturias-Medical Oncology ( Site 0182)

Oviedo, Principality of Asturias, 33011, Spain

RECRUITING

Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 0181)

Barcelona, 08035, Spain

RECRUITING

Hôpitaux Universitaires de Genève (HUG) ( Site 0202)

Geneva, Canton of Geneva, 1211, Switzerland

RECRUITING

Ospedale Regionale Bellinzona e Valli ( Site 0201)

Bellinzona, Canton Ticino, 6500, Switzerland

RECRUITING

China Medical University Hospital ( Site 0223)

Taichung, 404332, Taiwan

RECRUITING

National Cheng Kung University Hospital-Clinical Trial Center ( Site 0224)

Tainan, 704, Taiwan

RECRUITING

National Taiwan University Hospital-Oncology ( Site 0225)

Taipei, 10002, Taiwan

RECRUITING

Taipei Veterans General Hospital ( Site 0221)

Taipei, 112, Taiwan

RECRUITING

Chang Gung Medical Foundation-Linkou Branch ( Site 0222)

Taoyuan District, 33305, Taiwan

RECRUITING

Hacettepe Universite Hastaneleri-oncology hospital ( Site 0241)

Ankara, 06230, Turkey (Türkiye)

COMPLETED

Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 0242)

Ankara, 06800, Turkey (Türkiye)

COMPLETED

Barts Health NHS Trust ( Site 0263)

London, England, E1 1RD, United Kingdom

RECRUITING

Royal Free Hospital ( Site 0262)

London, England, NW3 2QG, United Kingdom

RECRUITING

University Hospital Coventry & Warwickshire ( Site 0266)

Coventry, CV2 2DX, United Kingdom

RECRUITING

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Conditions

Colorectal Neoplasms; Biliary Tract Neoplasms

Interventions

Fluorouracil; Leucovorin; Levoleucovorin; Cisplatin; pembrolizumab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Biliary Tract Diseases

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Central Study Contacts

Toll Free Number

CONTACT

1-888-577-8839; Trialsites@msd.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2024
• First Posted: May 24, 2024
• Study Start: June 20, 2024
• Primary Completion (Estimated): October 16, 2029
• Study Completion (Estimated): October 16, 2029
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

TW (5); US (13); CL (4); CN (6); CA (3); IT (3); ES (3); TU (2); CH (2); GB (3); AU (5); JP (2); KR (4)