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A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of GenSci140 in Participants With Advanced Solid Tumors

NCT07251166 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2025-12-24

No results posted yet for this study

Summary

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).

Conditions

Interventions

DRUG

GenSci140 for Injection

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).

Sponsors & Collaborators

  • Changchun GeneScience Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-10
Primary Completion
2028-03-31
Completion
2028-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07251166 on ClinicalTrials.gov