This is a phase I, multi-center, open-label, dose-escalation (Part 1) and dose-expansion (Part 2) first-in-human study in China to evaluate the safety, tolerability, PK profile and efficacy of GenSci140 in participants with advanced solid tumors, and to determine the MTD (if any) and RDE. The dose-expansion study aims to evaluate the efficacy, safety and PK profile of GenSci140 in the treatment of ovarian cancer or other FRα-positive advanced solid tumors at different dose levels, and to select an appropriate RP2D (if applicable).
Those who are able to understand and willing to sign written Informed Consent Form.
Aged between 18 and 75 years (inclusive) when signing the ICF
Participants with advanced solid tumors
The participant agrees to provide fresh biopsy or archived tumor tissues for testing by the central laboratory.
Past history of cancers.
Symptomatic primary central nervous system (CNS) tumors, metastases, leptomeningeal carcinomatosis, or therapy naive spinal cord compression.
Use of an investigational medicinal product (IMP) or antitumor therapy (including chemotherapy, biologic therapy, immunotherapy) within 5 half-lives or 4 weeks before the first dose of GenSci140. Concomitant anti-tumor therapy is not permitted
Major surgery within 4 weeks prior to the first dose of GenSci140.
Single group
GenSci140 for Injection
DrugParticipants will receive GenSci140 on Day 1 of each 21-day cycle. GenSci140 will be administered until unacceptable toxicity, disease progression, withdrawal of informed consent, death, loss to follow-up, or initiation of new anti-tumor therapy (whichever occurs first).
Incidence and severity of adverse event (AEs), and incidence of dose limiting toxicities（DLTs）
To determine the MTD (if any) of GenSci140 in participants with advanced solid tumors
maximal tolerance dose （MTD）
To determine the MTD (if any) of GenSci140 in participants with advanced solid tumors
recommended dose of expansion （RDE）
To determine the RDE of GenSci140 in participants with advanced solid tumors
objective response rate（ORR）
To evaluate the preliminary efficacy of GenSci140 in participants with advanced solid tumors
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