Fortvita Biologics (USA)Inc.
This is a Phase 1 multicenter, multi-regional, open-label, first-in-human study of IBI3001 in participants with unresectable, locally advanced or metastatic solid tumors. The purpose of this study is to identify the MTD/RP2D of IBI3001, and to explore the preliminary efficacy of IBI3001.
Key Inclusion Criteria: 1. Male or female participants ≥ 18 years old; 2. Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1; 3. Has an anticipated life expectancy of ≥ 12 weeks; 4. Adequate bone marrow and organ function: 5. At least 1 evaluable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. for dose escalation , and 1 measurable lesion for dose expansion. 6. Has a documented (histologically- or cytologically-proven), unresectable, locally advanced or metastatic solid tumor that is refractory to or intolerable with stand…
The provisional dose levels are planned to be evaluated, but it is possible for additional and/or intermediate dose levels to be added during the study. IBI3001 is proposed to be administered by intravenous infusion (IV)