NCT06428409Recruiting
A Clinical Study of MK-2870 Alone or With Other Treatments to Treat Gastrointestinal Cancers (MK-9999-02A)
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
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
Contacts
The trial team's contact details are shown on request.
See the official trial record- Status
- Recruiting
- Phase
- Phase 1 · Phase 2
- Study type
- Interventional
- Countries
- Switzerland, Italy, United States, Australia, Canada, Chile, China, Japan, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom
- Sponsor
- Merck Sharp & Dohme LLC(Industry)
- Protocol no.
- 9999-02A
- Conditions
- Colorectal Cancer, Pancreatic Ductal Adenocarcinoma, Biliary Tract Cancer
- Interventions
- Biological, Drug
Treatments studied
- Sacituzumab tirumotecan
- Fluorouracil (5-FU)
- Leucovorin (LV) or levoleucovorin
- Rescue medication
- Supportive care measures
- Cisplatin
- Pembrolizumab
Locations · 36
- Geneva, SwitzerlandHôpitaux Universitaires de Genève (HUG) ( Site 0202)Recruiting at this site
- Bellinzona, SwitzerlandOspedale Regionale Bellinzona e Valli ( Site 0201)Recruiting at this site
- Milan, ItalyFondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 0101)Recruiting at this site
- Milan, ItalyASST Grande Ospedale Metropolitano Niguarda ( Site 0102)Recruiting at this site
- Roma, ItalyFondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 0103)Recruiting at this site
- Los Angeles, United StatesUCLA ( Site 0317)Recruiting at this site
- Aurora, United StatesUniversity of Colorado Anschutz Medical Campus ( Site 0299)Recruiting at this site
- Aurora, United StatesUniversity of Colorado Anschutz Medical Campus ( Site 0325)Recruiting at this site
- Aurora, United StatesUniversity of Colorado Anschutz Medical Campus ( Site 0326)Recruiting at this site
- Washington D.C., United StatesSibley Memorial Hospital ( Site 0310)Recruiting at this site
- Gainesville, United StatesUniversity of Florida College of Medicine ( Site 0281)Recruiting at this site
- Mineola, United StatesPerlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0327)Recruiting at this site
- New York, United StatesLaura and Isaac Perlmutter Cancer Center at NYU Langone ( Site 0324)Recruiting at this site
- Houston, United StatesUniversity of Texas MD Anderson Cancer Center ( Site 0316)Recruiting at this site
- Roanoke, United StatesOncology and Hematology Associates of Southwest Virginia (BRCC) ( Site 0295)Recruiting at this site
- Madison, United StatesUniversity Hospital and UW Health Clinics-Carbone Cancer Center ( Site 0293)Recruiting at this site
- Ottawa, CanadaThe Ottawa Hospital Cancer Centre ( Site 0027)Recruiting at this site
- Montreal, CanadaCentre Hospitalier de l'Université de Montréal-Unit for Innovative Therapies ( Site 0022)Recruiting at this site
- Temuco, ChileJames Lind Centro de Investigacion del Cancer ( Site 0048)Recruiting at this site
- Providencia, ChileFALP-UIDO ( Site 0041)Recruiting at this site
- Santiago, ChileClínica UC San Carlos de Apoquindo ( Site 0043)Recruiting at this site
- Santiago, ChileBradfordhill-Clinical Area ( Site 0047)Recruiting at this site
- Beijing, ChinaBeijing Cancer hospital-Digestive Oncology ( Site 0061)Recruiting at this site
- Fuzhou, ChinaThe 900th Hospital of the Joint Logistics Support Force of the Chinese People's Liberation Army ( Site 0063)Recruiting at this site
- Chengdu, ChinaWest China Hospital, Sichuan University ( Site 0068)Recruiting at this site
- Kashiwa, JapanNational Cancer Center Hospital East ( Site 0121)Recruiting at this site
- Yokohama, JapanKanagawa Cancer Center ( Site 0122)Recruiting at this site
- Seoul, South KoreaSeoul National University Hospital ( Site 0161)Recruiting at this site
- Seoul, South KoreaSeverance Hospital, Yonsei University Health System ( Site 0164)Recruiting at this site
- Seoul, South KoreaAsan Medical Center ( Site 0163)Recruiting at this site
In total, worldwide, 36 of the 55 sites listed in the registry are recruiting; the other 19 are not currently recruiting.
Site status per the ClinicalTrials.gov registry (last update posted: October 20, 2026).
This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.
+ 6 more locations
Other identifiers
- MK-9999-02A · other identifier
- 2023-508703-21-00 · other registry
- U1111-1298-8273 · other registry
- jRCT2031240178 · other registry
- 2023 · NIH grant
See also
Other versions
These results are indicative and do not replace medical advice — discuss them with your doctor.