Recruiting nowPhase 2
| Registry number | NCT06428409 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 2 |
| Design | not randomised, open label |
| Taking part | 220 people (planned) |
| Who can join | aged 18 Years and over |
| Run by | Merck Sharp & Dohme LLC |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Biological Sacituzumab tirumotecan
- Drug Fluorouracil (5-FU)
- Drug Leucovorin (LV) or levoleucovorin
- Drug Rescue medication
- Drug Supportive care measures
- Drug Cisplatin
- Biological Pembrolizumab
What it is measuring
Number of Participants Who Experience a Dose-limiting Toxicity (DLT)
This is the trial's main question — the one it is designed and sized to answer. Anything else it reports is a secondary finding, and secondary findings are far more likely to be chance.
Phase 2. Tests whether the treatment works well enough to be worth a larger trial. Usually too small to prove it changes survival.
How the researchers describe it
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 treatmentWritten by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
- Metastatic
Read automatically from the criteria below, to make the list searchable. It is a summary of what the text mentions, not a decision about whether you qualify — and where the two disagree, the criteria are right and this is wrong.
Who the trial is looking for
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
This is an extract. Whether you qualify is decided by the trial team against the full criteria, not by reading this page. Read the full eligibility criteria
Where it is running
Running at 55 sites. Listed in: Australia, Canada, Chile, China, Italy, Japan, South Korea, Spain, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom, United States.
Individual hospitals, and whether each is currently open, are listed on the registry record. Sites open and close throughout a trial.
Worth asking your oncology team
Being listed here is not a recommendation, and no one page can tell you whether a trial is right for you. These are the questions it raises.
- Is this trial open at a hospital I could realistically travel to?
- Given my stage, my previous treatment and my tumour's molecular profile, would I be eligible?
- What would I be giving up by joining — is the comparison arm the treatment I would otherwise be having?
- What is already known about the safety of what is being tested?
The source
Registry record NCT06428409, registered by Merck Sharp & Dohme LLC on ClinicalTrials.gov, a public database run by the US National Library of Medicine. The details on this page come from that record and are only ever as current as the sponsor has kept it.
This is a listing of a registered clinical trial, reproduced for information. It is not a recommendation, this site has no connection to the trial or its sponsor, and being listed here says nothing about whether the treatment works. Talk to your own oncology team before pursuing any trial.
This article summarises published research for general information. It is not medical advice, and it is not a substitute for a conversation with your own oncology team, who know your case. Do not start, stop, or change any treatment or supplement on the basis of what you read here.