Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT07230977

GenSci139 in Patients With Advanced Solid Tumors

Led by Changchun GeneScience Pharmaceutical Co., Ltd. · Updated on 2025-12-24

280

Participants Needed

1

Research Sites

163 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is a phase I, two-part, multicenter, first-in-human study. The Part 1 study will assess the safety, tolerability, preliminary anti-tumor activities, PK profile, immunogenicity and biomarker of GenSci139 in participants with locally advanced or metastatic solid tumors, as well as identity MTD (if any) and RDE. The Part 2 study is to further evaluate the preliminary anti-tumor activities, safety, PK profile, immunogenicity and biomarker of GenSci139 at RDE dose levels with selected advanced cancers.

CONDITIONS

Official Title

GenSci139 in Patients With Advanced Solid Tumors

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Ability and willingness to sign a written informed consent document before starting GenSci139 and any study procedures
  • Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
  • Adults aged 18 years or older (or acceptable age per local regulations) at time of informed consent
  • Ability to provide tumor tissue; fresh biopsy or archival tumor samples obtained after last treatment are preferred
  • At least one measurable lesion by RECIST v1.1 criteria
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Left ventricular ejection fraction (LVEF) of 50% or higher
  • Life expectancy of at least 3 months
  • Adequate hematologic and organ function before starting GenSci139
  • Women of childbearing potential must agree to use effective contraception during treatment and for 6 months after last dose, and have a negative serum human chorionic gonadotropin (HCG) test
  • Nonsterile males must agree to use effective contraception during treatment and for 6 months after last dose
  • Histologically or cytologically confirmed locally advanced or metastatic cancers including UC, HNSCC, TNBC, NSCLC, BTC, ESCC, GC, CRC, OC, NPC, PDAC, etc., who have progressed after standard therapy or have no effective standard treatment options
Not Eligible

You will not qualify if you...

  • Active malignancy within 3 years before starting GenSci139, except the cancer under study or locally recurring cancers treated curatively
  • Diagnosis of primary central nervous system (CNS) tumor
  • CNS metastases unless asymptomatic, neurologically stable, and off steroids for at least 4 weeks before starting GenSci139
  • History of leptomeningeal disease or spinal cord compression
  • Stroke or transient ischemic attack within 6 months prior to starting GenSci139
  • Active autoimmune or inflammatory diseases
  • History or current interstitial lung disease (ILD) or pneumonitis requiring steroids or suspected ILD/pneumonitis not ruled out by imaging
  • Unstable thrombotic events within 6 months prior to starting GenSci139
  • Severe chronic or active infection
  • Uncontrolled hypertension
  • Clinically significant cardiovascular disease
  • Known severe hypersensitivity to GenSci139 or its components
  • History of severe hypersensitivity reactions to other monoclonal antibodies
  • Insufficient washout period from certain therapies as specified in protocol
  • Known HIV infection, active hepatitis B or C infection
  • Unresolved toxicities from prior anticancer therapy
  • Prior treatment with HER2 or EGFR monoclonal antibodies or use of TOPO I inhibitor as payload targeted to HER2 or EGFR ADC with intolerance
  • Pregnancy, lactation, or planning pregnancy
  • Uncontrollable pleural, pericardial, abdominal, or pelvic effusions requiring drainage or diuretics within 14 days before GenSci139 infusion
  • Other conditions deemed inappropriate for participation by investigators

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Shandong First Medical University Affiliated Cancer Hospital

Jinan, Shandong, China, 250117

Actively Recruiting

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Research Team

J

Jinming Yu, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

3

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