Tests MK-2870 alone or with other drugs for gastrointestinal cancers
Tests MK-2870 in adults with advanced bowel, pancreas or bile duct cancer.
Key facts
- Who runs it
- Merck Sharp & Dohme LLC
- Where
- Bellinzona and Geneva, SwitzerlandSee the 2 sitesAlso in 12 other countries, 53 sites
- Trial code
- NCT06428409
- EU 2023-508703-21-00
- JRCT2031240178
- U1111-1298-8273
- Registry title
- A Clinical Study of MK-2870 Alone or With Other Treatments to Treat Gastrointestinal Cancers (MK-9999-02A)
- Status
- Recruiting
- Phase
- Phase 1/2
- People taking part
- 220 people, planned
- Started
- 20 Jun 2024
- Expected to end
- 16 Oct 2029
- Type of study
- Interventional, 3 groups
- Treatments tested
- Sacituzumab tirumotecan
- Fluorouracil (5-FU)
- Leucovorin (LV) or levoleucovorin
- Rescue medication
- Supportive care measures
- Cisplatin
- Pembrolizumab
- Record updated
- 29 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with advanced colorectal, pancreatic or biliary tract cancer that cannot be removed by surgery. It tests MK-2870 alone or with other treatments.
- Age
- 18 years or older
- Sex
- Men and women can join
- Disease stage
- Unresectable or metastatic colorectal cancer; advanced or metastatic pancreatic ductal adenocarcinoma (PDAC); advanced and/or unresectable biliary tract cancer (BTC)
- Earlier treatment
- Colorectal cancer and PDAC: must have had earlier cancer treatment. Biliary tract cancer: both people who have and have not had earlier treatment can join. Anyone with earlier treatment must have recovered from its side effects.
Main reasons for not taking part
- History of severe eye disease
- Earlier systemic cancer treatment, including trial drugs, within 4 weeks before starting the study treatment
- History of pneumonitis or interstitial lung disease (ILD) that needed steroids
- Current pneumonitis or ILD
- Suspected pneumonitis or ILD that standard tests at screening cannot rule out
The registry criteria, word for word
Show all 7 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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 severe eye disease
- 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
- The main exclusion criteria include but are not limited to the following:
Where in Switzerland
Also in 12 other countries, 53 sites
- Ospedale Regionale Bellinzona e Valli (Site 0201)Bellinzona, SwitzerlandContact: Study CoordinatorTaking people
- Hôpitaux Universitaires de Genève (HUG) (Site 0202)Geneva, SwitzerlandContact: Study CoordinatorTaking people
About the trial
What the trial wants to find out
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:
Read full original descriptionShow less
* 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
The 3 groups in the trial
- Sacituzumab tirumotecan + ChemotherapyTreatment being tested
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.
Treatment: Sacituzumab tirumotecan, Fluorouracil (5-FU), Leucovorin (LV) or levoleucovorin, Rescue medication, and Supportive care measures
- Sacituzumab tirumotecanTreatment being tested
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.
Treatment: Sacituzumab tirumotecan, Rescue medication, and Supportive care measures
- Sacituzumab tirumotecan + Cisplatin + PembrolizumabTreatment being tested
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.
Treatment: Sacituzumab tirumotecan, Rescue medication, Supportive care measures, Cisplatin, and Pembrolizumab
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official 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
- Plain-language title
- Tests MK-2870 alone or with other drugs for gastrointestinal cancersGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 29 October 2026