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.
Male or female participants ≥ 18 years old;
Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1;
Has an anticipated life expectancy of ≥ 12 weeks;
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.
Progressed or refractory to an ADC that consists of an Exatecan derivative that is a topoisomerase I inhibitor or intolerable with an ADC that consists of Exatecan;
Plan to receive other antitumor therapy during the study excluding palliative radiotherapy for the purpose of symptom (like pain) relief that must also not have an impact on tumor assessment throughout the study;
Pyloric obstruction and/or persistent recurrent vomiting (≥ 3 times in 24 hours);
Gastrointestinal perforation and/or fistula within 6 months prior to first administration of the study drug, and not recovered after surgical treatment;
Single group
IBI3001
DrugThe 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)
Number of subjects with adverse events
Occurrence and severity of adverse events (AEs), with severity determined by NCI CTCAE v5.0 criteria
Number of subjects with clinically significant changes in physical examination results
Clinically significant abnormal physical examination findings reported by the investigator.
Number of subjects with clinically significant changes in vital signs
Vital signs including body temperature, pulse, respiratory rate, SpO2 and blood pressure
MTD or RP2D of IBI3001 Number of subjects with dose-limiting toxicities (DLTs)
Dose limiting toxicity (DLT) to establish MTD or RP2D
Plasma concentration (Cmax) of IBI3001
Plasma concentration of IBI3001 for single and multiple doses.
Area under the curve (AUC) of IBI3001
AUC of IBI3001 for single and multiple doses
Time to maximum concentration (Tmax) of IBI3001
Tmax of IBI3001 for single and multiple doses.
Clearance (CL) of IBI3001
Clearance of IBI3001 from the plasma
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Fortvita Biologics (USA)Inc.
Lead sponsor
Innovent Biologics (Suzhou) Co. Ltd.
Collaborator
