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FG-M108 and FG-B901 in Claudin 18.2 Positive Solid Tumors
NCT07704866Phase 2
Key facts
- Status
- Not yet recruiting
- Start
- Jul 2026
- Primary completion
- Aug 2028
- Countries
- 1
- Conditions
- solid tumor
01
Overview
Phase 2, open-label trial of FG-B901 and M108 in solid tumor (2 cohorts), sponsored by Beijing Mingzhi Zhishan Biotechnology. Primary endpoints: Safety assessed by Adverse Events (AEs) up to 24 months, Objective Response Rate up to 24 months and 1 more. Planned start Jul 2026; status: not yet recruiting.
02
Design
2 arms- Study design
- Non-randomizedOpen-label
Dose Escalation Cohort
Eight dose levels of FG-B901 combined with fixed-dosed FG-M108 tested according to an accelerated titration method followed by an adaptive BOIN design.
Dose Expansion Cohort
1-2 expansion cohorts to evaluate the efficacy and safety of the selected dose of FG-B901 combined with fixed-dosed FG-M108.
03
Who it enrols
Patients aged 18-75 with CLDN18.2-positive unresectable locally advanced or metastatic solid tumors who have failed or are intolerant to standard therapy, with ECOG 0-1 and measurable disease.
04
Endpoints
Primary
Safety assessed by Adverse Events (AEs)
Objective Response Rate
Disease Control Rate
Secondary
Progression Free Survival
Duration Of Response
Overall Survival
Time to Progression
Maximum measured plasma concentration
Time to maximum plasma concentration
Half-life
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