At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Sacituzumab tirumotecan (biological), Fluorouracil (5-FU) (drug), Leucovorin (LV) or levoleucovorin (drug), Rescue medication (drug)
- How long the study runs
- Study runs about 64 months (dates as stated)
- About the drug or intervention
- Sacituzumab tirumotecan — biological: Given by IV infusion. · 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. · 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. · Cisplatin — drug: Given by IV infusion. · Pembrolizumab — biological: Given by IV infusion.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 220
- Started
- 2024-06-20
- Last checked
- 2026-10
Plain English Summary
What is this study?
- • Testing a new treatment for colorectal cancer
- • Phase1/Phase2 - 220 participants
- • Researchers want to learn if sacituzumab tirumotecan (MK-2870) alone or with other treatments can treat certain gastrointestinal (GI) cancers
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with colorectal cancer
Where?
- • London - Barts Health NHS Trust ( Site 0263)
- • London - Royal Free Hospital ( Site 0262)
- • Coventry - University Hospital Coventry & Warwickshire ( Site 0266)
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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
Colorectal CancerPancreatic Ductal AdenocarcinomaBiliary Tract Cancer
How this trial compares with your answers
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What we know so far
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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓The main inclusion criteria include but are not limited to the following:
- ✓Has one of the following cancers:
- ✓Unresectable or that has spread colorectal cancer and has received prior therapy for the cancer
- ✓Advanced or that has spread 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
Who cannot take part
- ✗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...
See the full criteria
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
Where Is This Study? (3 UK sites)
Barts Health NHS Trust ( Site 0263)
London E1 1RD, United Kingdom
Site contact (verified)
Study Coordinator07918804584
Royal Free Hospital ( Site 0262)
London NW3 2QG, United Kingdom
Site contact (verified)
Study Coordinator02077940500 ext38682
University Hospital Coventry & Warwickshire ( Site 0266)
Coventry CV2 2DX, United Kingdom
Site contact (verified)
Study Coordinator02476967485
How to Get in Touch
Toll Free Number
Sponsor contactCONTACT
1-888-577-8839 Trialsites@msd.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-10