GenSci139 in Patients With Advanced Solid Tumors

NCT07230977 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: GenSci139-101
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

Brief Summary

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

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (6)

• Part 1 and Part2: Incidence of adverse events

  Percentage of patients with adverse events by system organ class and preferred term

  From time of informed consent to 30 days post last dose of GenSci139

• Dose limiting toxicities (DLTs)

  DLTs are assessed during the DLT observation period and defined as any toxicity in DLT definition in the Clinical Study Protocol

  from time of first dose of GenSci139 to end of DLT observation period(approximately 21 days)

• Part1: Maximum Tolerated Dose (MTD) and Recommended Doses for Expansion (RDEs)

  To determine the maximum tolerated dose (MTD), if any, and recommend dose of expansion (RDE) for GenSci139

  from time of first dose of GenSci139 up to 18 months

• Part2: Objective response rate(ORR)

  To evaluate the preliminary anti-tumor activities of GenSci139 as measured by ORR using RECIST criteria v1.1.

  approximately 12 months

• Part2: disease control rate (DCR)

  To evaluate the preliminary anti-tumor activities of GenSci139 as measured by DCR using RECIST criteria v1.1.

  approximately 12 months

• Part2: Duration of response (DoR)

  To evaluate the preliminary anti-tumor activities of GenSci139 as measured by DoR using RECIST criteria 1.1.

  approximately 24 months

Secondary Outcomes (25)

• Cmax of GenSci139

  approximately 24 months

• Part1: Cmax of total antibody

  approximately 24 months

• Part1: Cmax of free payload

  approximately 24 months

• Part1: Tmax of GenSci139

  approximately 24 months

• Part1: Tmax of total antibody

  approximately 24 months

Study Arms (3)

Part1 dose escalation

EXPERIMENTAL

dose escalation cohorts of GenSci139 in sequential ascending order

Drug: GenSci139

Part 1 backfill

EXPERIMENTAL

backfill study at dose levels proved safety and efficacy during dose escalation

Drug: GenSci139

Part 2 dose expansion

EXPERIMENTAL

Dose expansion at RDE dose levels with selected advanced cancers.

Drug: GenSci139

Interventions

GenSci139 DRUG

GenSci139 is a bispecific antibody drug conjugate targeting EGFR and HER2.

Part 1 backfill; Part 2 dose expansion; Part1 dose escalation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Changchun GeneScience Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Shandong First Medical University Affiliated Cancer Hospital

Jinan, Shandong, 250117, China

RECRUITING

Central Study Contacts

Jinming Yu, MD

CONTACT

0531-67626971; sdyujinming@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2025
• First Posted: November 17, 2025
• Study Start: November 19, 2025
• Primary Completion (Estimated): July 7, 2028
• Study Completion (Estimated): January 8, 2029
• Last Updated: December 24, 2025

Record last verified: 2025-09

Locations

CN (1)