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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Level 1~ Dose Level 5 | Experimental | Participants who meet the inclusion criteria and do not meet the exclusion criteria will be sequentially enrolled into five pre-specified doses for dose groups 1-5. |
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| Cohort 1~ Cohort 4 | Experimental | Cohort 1: Cohort 1 is planned to be conducted in patients with ovarian cancer. Cohort 2: FRα-positive endometrial cancer. Cohort 3: FRα-positive lung cancer. Cohort 4: FRα-positive triple negative breast cancer. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GenSci140 for Injection | Drug | Participants 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 3 weeks |
| maximal tolerance dose (MTD) | To determine the MTD (if any) of GenSci140 in participants with advanced solid tumors | up to 3 months |
| recommended dose of expansion (RDE) | To determine the RDE of GenSci140 in participants with advanced solid tumors | up to 3 months |
| objective response rate(ORR) | To evaluate the preliminary efficacy of GenSci140 in participants with advanced solid tumors | up to 5 months |
| duration of response(DOR) | To evaluate the preliminary efficacy of GenSci140 in participants with advanced solid tumors | up to 5 months |
| disease control rate(DCR) | To evaluate the preliminary efficacy of GenSci140 in participants with advanced solid tumors | up to 5 months |
| Incidence and severity of adverse event (AEs) | To evaluate the safety and tolerability of GenSci140 at specific doses in participants with specific advanced solid tumors. | up to 5 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wen Xu | Contact | +8618861095711 | xuwen01@genscigroup.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Hospital of China Medical University | Recruiting | Shenyang | Liaoning | 110001 | China |
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|
| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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