MK9999-02A Protocol 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 Cancer
Details
Status
Open: Currently recruiting participants.
Closed: Recruitment either has not started or has paused or completed.
Study Type
Interventional (clinical trials): Test treatments.
Observational: Conduct surveys and interviews, study medical records and otherwise observe people or groups over time.
Interventional
Study Phase
Each study phase tests different aspects of the medication or treatment:
- Phase I: safety and dosing
- Phase II: effectiveness and side effects
- Phase III: efficacy compared to standard treatments
- Phase IV: long-term safety after approval for use
I
Location(s)
Johns Hopkins study sites. Additional study locations may be found on ClinicalTrials.gov.
Sibley Memorial Hospital
5255 Loughboro Road, N.W., Washington, D.C., 20016
Contact Us
(410) 955-8964Brief Summary
Researchers want to learn if sacituzumab tirumotecan (MK-2870) alone or with chemotherapy 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 and how well people tolerate sacituzumab tirumotecan alone or with chemotherapy
- How many people have the cancer respond (get smaller or go away) to treatment
Eligibility
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
- Advanced or metastatic pancreatic ductal adenocarcinoma (PDAC)
- Advanced and/or unresectable biliary tract cancer (BTC)
Has received prior therapy for the 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
- Received prior systemic anticancer therapy including investigational agents within 4 weeks before starting study intervention
- History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease