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
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
220
Given by IV infusion.
5-FU is administered by IV infusion over 46 to 48 hours every 2 weeks.
LV or levoleucovorin is administered by IV infusion every 2 weeks.
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. A steroid mouthwash (dexamethasone or equivalent) will be given as prophylaxis for stomatitis/oral mucositis.
Participants are allowed to take supportive care measures for the management of adverse events associated with study intervention at the discretion of the investigator. Supportive care measures may include but are not limited to antidiarrheal agents and antiemetic agents. Artificial tear drops or gel may be given as supportive care for Ocular Surface Toxicity.
Given by IV infusion.
Given by IV infusion.
UCLA ( Site 0317)
Los Angeles, California, United States
RECRUITINGUniversity of Colorado Anschutz Medical Campus ( Site 0299)
Aurora, Colorado, United States
RECRUITINGUniversity of Colorado Anschutz Medical Campus ( Site 0325)
Aurora, Colorado, United States
RECRUITINGUniversity of Colorado Anschutz Medical Campus ( Site 0326)
Aurora, Colorado, United States
Number of Participants Who Experience a Dose-limiting Toxicity (DLT)
A DLT is a medical problem related to the study medicine that prevents giving participants a higher dose or may prevent giving the participant the same dose. The number of participants who experience a DLT will be reported.
Time frame: Up to approximately 4 weeks
Number of Participants Who Experience One or More Adverse Events (AEs)
An AE is a health problem that happens or worsens during the study. The number of participants who have an AE during the study will be reported.
Time frame: Up to approximately 63 months
Number of Participants who Discontinue Study Treatment due to an AE
An AE is a health problem that happens or worsens during a study. The number of participants who stop study treatment will be reported.
Time frame: Up to approximately 63 months
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Blinded Independent Central Review (BICR)
ORR is defined as the percentage of participants with confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.
Time frame: Up to approximately 63 months
Duration of Response (DOR) per RECIST 1.1 as Assessed by BICR
For participants who demonstrate a confirmed Complete Response or Partial Response, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by BICR will be presented.
Time frame: Up to approximately 63 months
Progression-free Survival (PFS) per RECIST 1.1 as Assessed by BICR
PFS is defined as the time from start of study treatment to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. According to RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by BICR will be presented.
Time frame: Up to approximately 63 months
Overall Survival (OS)
OS is the length of time from when the participant starts treatment until death from any cause
Time frame: Up to approximately 63 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Sibley Memorial Hospital ( Site 0310)
Washington D.C., District of Columbia, United States
RECRUITINGUniversity of Florida College of Medicine ( Site 0281)
Gainesville, Florida, United States
RECRUITINGMount Sinai Cancer Center ( Site 0287)
Miami Beach, Florida, United States
RECRUITINGNorthwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 0303)
Marietta, Georgia, United States
COMPLETEDPerlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0327)
Mineola, New York, United States
RECRUITINGLaura and Isaac Perlmutter Cancer Center at NYU Langone ( Site 0324)
New York, New York, United States
RECRUITING...and 45 more locations