A Phase I Study of Safety, Tolerability, Pharmacokinetics and Preliminary Anti-Tumor Activity of the Oral KIF18A Inhibitor GenSci122 in Participants With Advanced Solid Tumors

Changchun GeneScience Pharmaceutical Co., Ltd.9 sites in 1 country163 target enrollmentJanuary 8, 2025

ConditionsAdvanced Solid Tumor

InterventionsGenSci122 tablet 50mg GenSci122 tablet 250mg

DrugsGenSci122 tablet 50mg GenSci122 tablet 250mg

Overview

Phase: Phase 1
Intervention: GenSci122 tablet 50mg
Conditions: Advanced Solid Tumor
Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.
Enrollment: 163
Locations: 9
Primary Endpoint: Dose escalation: Incidence of dose-limiting toxicities (DLTs).
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a first-in-human (FIH), multicenter, open-label, phase I study to evaluate the safety, tolerability, PK and preliminary efficacy of GenSci122 in participants with advanced solid tumors. The study consists of 2 parts: Part 1- dose-escalation and Part 2- dose expansion. The primary endpoint of Dose escalation is To assess the safety and tolerability of GenSci122. The primary endpoint of Dose expansion is to evaluate the preliminary anti-tumor activity of GenSci122 in participants with advanced solid tumors.

Registry

clinicaltrials.gov

Start Date

January 8, 2025

End Date

March 2031

Last Updated

last year

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Changchun GeneScience Pharmaceutical Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Provide informed consent and sign the informed consent form (ICF).
•Male or female participants ≥18 years old at the time of consent.
•Meeting the requirements of tumor types shown below:
•Dose escalation:
•Participants with a histological or cytological diagnosis of recurrent or metastatic advanced solid tumors who have failed or are intolerant to standard treatment, or have no standard therapy.
•Dose expansion:
•Participants with a histological or cytological diagnosis of recurrent or metastatic advanced solid tumors who have failed or are intolerant to standard treatment, or have no standard therapy.
•Participants agree to provide fresh or archived tumor tissue as well as corresponding pathological report.
•Survival expectations are ≥ 12 weeks.
•Eastern Cooperative Oncology Group performance status (ECOG PS) 0 to 1 (Appendix 1).

Exclusion Criteria

•Investigational agent or anticancer therapy within 5 half-lives or 4 weeks (whichever is shorter) before the first dose of GenSci
•In addition, no concurrent investigational anti-cancer therapy is permitted.
•Major surgery (excluding placement of vascular access) within 4 weeks before the first dose of GenSci
•Radiotherapy within 4 weeks before the first dose of GenSci
•Or participants have not yet recovered from acute effects of radiotherapy to baseline before the first dose of GenSci
•Symptomatic primary central nervous system (CNS) tumor, metastases, leptomeningeal carcinomatosis, or untreated spinal cord compression.
•Clinically significant active cardiovascular disease or history of myocardial infarction within 6 months before the first dose of GenSci
•Active uncontrolled systemic bacterial, viral, or fungal infection, or serious ongoing intercurrent illness, such as hypertension or diabetes, despite optimal treatment. Screening for chronic conditions is not required.
•Inability to swallow pills or clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal absorption of GenSci
•Pregnancy or lactation.

Arms & Interventions

Single arm

Intervention: GenSci122 tablet 50mg

Single arm

Intervention: GenSci122 tablet 250mg

Outcomes

Primary Outcomes

Dose escalation: Incidence of dose-limiting toxicities (DLTs).

Time Frame: 2 years

Dose expansion: Objective response rate (ORR) evaluated by investigator based on response evaluation criteria in solid tumors version 1.1 (RECIST v1.1).

Time Frame: 3 Years

Secondary Outcomes

Incidence and severity of TEAEs.(3 years)
Maximum Plasma Concentration (Cmax) of Gensci122(3 years)
Duration of Response (DOR)(3 years)
Progression-free Survival (PFS)(3 years)
Overall Survival (OS)(3 years)
Time to Maximum Plasma Concentration (Tmax) of Gensci122(3 years)
Area Under the Plasma Concentration-time Curve (AUC) Over the Dosing Interval for Gensci122(3 years)