A Clinical Study of MK-2870 Alone or With Other Treatments to Treat Gastrointestinal Cancers (MK-9999-02A)
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMerck Sharp & Dohme LLC
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
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Sacituzumab tirumotecan
- Fluorouracil (5-FU)
- Leucovorin (LV) or levoleucovorin
- Rescue medication
- Supportive care measures
- Cisplatin
- Pembrolizumab
Treatment groups
220 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov