GenSci139 for adults with advanced solid tumors

A Phase I, Two-Part, Multicenter, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activities of GenSci139 in Patients With Locally Advanced or Metastatic Solid Tumors

This study will try GenSci139 in adults with locally advanced or metastatic solid tumors to see if it is safe and can slow or shrink tumors.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 280 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Jinan, Shandong)
• Trial ID: NCT07230977 on ClinicalTrials.gov

What this trial studies

This is a first-in-human, two-part Phase 1 trial that begins with dose-escalation to define the maximum tolerated dose (if any) and recommended dose for expansion while measuring safety, pharmacokinetics, immunogenicity, and biomarkers. Part 1 enrolls adults with locally advanced or metastatic solid tumors and requires measurable disease and adequate organ function. Part 2 expands at the recommended dose to further characterize preliminary anti-tumor activity, safety, PK, immunogenicity and biomarker signals in selected tumor types. The study requires tumor tissue (fresh or archival preferred) and serial blood sampling for PK and immunogenicity testing.

Who should consider this trial

Good fit: Adults (≥18) with locally advanced or metastatic solid tumors who have at least one measurable lesion, ECOG 0–1, adequate organ and heart function (LVEF ≥50%), and who can provide tumor tissue and attend study visits are ideal candidates.

Not a fit: Patients with poor performance status (ECOG ≥2), very limited life expectancy, or significant organ dysfunction are unlikely to benefit and may be ineligible.

Why it matters

Potential benefit: If successful, GenSci139 could provide a new treatment option that controls or reduces tumor growth for some patients with advanced solid tumors.

How similar studies have performed: This is first-in-human; while related targeted or immune-oncology agents have shown activity in some solid tumors, GenSci139 itself has not yet been tested in humans.

Eligibility criteria

Inclusion Criteria:

* Has the ability to understand and the willingness to sign a written informed consent document (prior to the initiation dose of GenSci139 and any study procedures).
* Is willing and able to comply with the scheduled visits, treatment plan, laboratory tests and other specified study procedures.
* Adult participants (≥18 years of age or acceptable age according to local regulations, whichever is older) at the time of voluntarily signing informed consent.
* Is able to provide tumor tissues. Fresh biopsy specimens or archival tumor tissue samples obtained after last treatment are strongly preferred, and if not available, providing other archival tumor tissue specimens or not may be enrolled after discussion with sponsor.
* Has at least one measurable lesion by RECIST v1.1.
* Has an eastern cancer collaboration group (ECOG) status of 0 or 1.
* Left ventricular ejection fraction (LVEF) ≥50%.
* Has a life expectancy of ≥ 3 months.
* Has adequate hematologic and organ function prior to initiation dose of GenSci139.
* Women of childbearing potential (WOCBP) must be willing to use adequate contraception while receiving GenSci139, and within 6 months after the last dose of GenSci139 and have a negative serum human chorionic gonadotropin (HCG) test.
* Nonsterile males must be willing to use adequate contraception for the duration of receiving GenSci139 and within 6 months after the last dose of GenSci139.
* Has histologically or cytologically confirmed locally advanced or metastatic UC, HNSCC, TNBC, NSCLC, BTC, ESCC, GC, CRC, OC, NPC, PDAC etc. and have progressed following standard therapy, or for whom, in the opinion of the investigator, no available and effective standard therapy exists.

Key Exclusion Criteria:

* Any active malignancy within 3 years before initiation dose of GenSci139 except for the cancer under investigation in this study and any locally recurring cancer that has been treated curatively (e.g., resected basal or squamous cell skin cancer, non-muscle invasive bladder cancer (NMIBC), carcinoma in situ of the cervix or breast).
* Has diagnosed as primary central nervous system (CNS) tumor.
* Has CNS metastases, unless asymptomatic, neurologically stable and not requiring steroids treatment for at least 4 weeks prior to initiation dose of GenSci139.
* Has a history of leptomeningeal disease or spinal cord compression.
* Has stroke or transient ischemic attack within 6 months prior to initiation dose of GenSci139.
* Active autoimmune diseases and inflammatory diseases.
* Has a history of (non-infectious) interstitial lung disease (ILD) / pneumonitis that required steroids, has current ILD / pneumonitis, or where suspected ILD / pneumonitis cannot be ruled out by imaging at screening.
* Unstable thrombotic events within 6 months prior to initiation dose of GenSci139.
* Has severe chronic or active infection
* Uncontrolled hypertension
* Has clinically significant cardiovascular disease
* Known severe hypersensitivity to GenSci139 and/or any of its excipients.
* Has a history of severe hypersensitivity reactions to other monoclonal antibodies
* With enough washout period to some therapies specified in protocol.
* Known HIV infection, active HBV or HCV infection.
* Has unresolved toxicities from previous anticancer therapy
* Had received HER2 or EGFR monoclonal antibodies, or using TOPO I inhibitor as payload, targeted to HER2 or EGFR ADC, and could not be intolerance of those treatment.
* Women who are pregnant or lactating or are planning to become pregnant.
* Uncontrollable pleural effusion, pericardial effusion, or abdominal and pelvic effusion requiring drainage and/or diuretics within 14 days prior to GenSci139 infusion.
* The other conditions of participation in this clinical trial were not considered appropriate by the investigators.

Where this trial is running

Jinan, Shandong

• Shandong First Medical University Affiliated Cancer Hospital — Jinan, Shandong, China (Recruiting)

Study contacts

• Study coordinator: Jinming Yu, MD

Conditions Advanced Solid Tumors