This Phase 2 study will be conducted in different countries around the world with up to about 160 participants. The purpose of this study is to evaluate how well Rina-S works against GI cancers. The medication in this study is Rina-S monotherapy (by itself; no other cancer treatments). All participants will receive active drug; no one will be given placebo. Participation in the study will require visits to the study site(s). During site visits, there will be various tests (such as blood draws) and procedures (such as recording of heart activity, imaging/X-rays) to monitor whether the study treatment is safe and effective. The duration of the study will be different for every participant, but an average study duration of 22 months is expected for participants. This will include a treatment period (expected to last an average of 12 months), plus data collection periods before and after treatment. Participants will be asked to attend 1 to 5 visits at the study clinic for each cycle (duration of an individual cycle is 21 days). If a participant's cancer stays the same or gets better, and there are not any serious problems, participants can keep getting study treatment for as long as the study is open.
This is a Phase 2, open-label, multicenter, multi-cohort trial to evaluate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics of Rina-S as monotherapy in participants with GI cancers who have progressed on or after prior standard of care (SoC) therapies.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
160
Intravenous (IV) administration.
START Midwest
Grand Rapids, Michigan, United States
RECRUITINGSTART San Antonio
San Antonio, Texas, United States
RECRUITINGNational Cancer Center Hospital East
Kashiwa, Chiba, Japan
RECRUITINGKanagawa Cancer Center
Yokohama, Kanagawa, Japan
RECRUITINGThe University of Osaka Hospital
Suita, Osaka, Japan
RECRUITINGCancer Institute Hospital of JFCR
Kōtoku, Tokyo-To, Japan
RECRUITINGConfirmed Objective Response Rate (ORR)
Time frame: Up to approximately 22 months
Duration of Response (DOR)
Time frame: Up to approximately 22 months
Disease Control Rate (DCR)
Time frame: Up to approximately 22 months
Progression-free Survival (PFS)
Time frame: Up to approximately 22 months
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to approximately 22 months
Maximum Concentration (Cmax) of Rina-S Related Analytes
Time frame: Up to approximately 12 months
Area Under the Concentration-time Curve (AUC) of Rina-S Related Analytes
Time frame: Up to approximately 12 months
Time to Reach Cmax (Tmax) of Rina-S Related Analytes
Time frame: Up to approximately 12 months
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