Recruiting NCT07230977
GenSci139 in Patients With Advanced Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: GenSci139.
- Who it may be relevant to
- Registry conditions: Advanced Solid Tumors. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- Drug GenSci139
GenSci139 is a bispecific antibody drug conjugate targeting EGFR and HER2.
Primary outcome measures
- Part 1 and Part2: Incidence of adverse events [Time frame: From time of informed consent to 30 days post last dose of GenSci139]
- Dose limiting toxicities (DLTs) [Time frame: 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) [Time frame: from time of first dose of GenSci139 up to 18 months]
- Part2: Objective response rate(ORR) [Time frame: approximately 12 months]
- Part2: disease control rate (DCR) [Time frame: approximately 12 months]
- Part2: Duration of response (DoR) [Time frame: approximately 24 months]
Secondary outcome measures (12)
- Cmax of GenSci139 [Time frame: approximately 24 months]
- Part1: Cmax of total antibody [Time frame: approximately 24 months]
- Part1: Cmax of free payload [Time frame: approximately 24 months]
- Part1: Tmax of GenSci139 [Time frame: approximately 24 months]
- Part1: Tmax of total antibody [Time frame: approximately 24 months]
- Part1: Tmax of free payload [Time frame: approximately 24 months]
- Part1: AUC of GenSci139 [Time frame: approximately 24 months]
- Part1: AUC of total antibody [Time frame: approximately 24 months]
- Part1: AUC of free payload [Time frame: approximately 24 months]
- Part1: Objective response rate(ORR) [Time frame: approximately 12 months]
- Part1: disease control rate (DCR) [Time frame: approximately 12 months]
- Part1: Duration of response (DoR) [Time frame: approximately 24 months]
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.
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Shandong First Medical University Affiliated Cancer Hospital — Jinan
Identifiers
NCT: NCT07230977 · GenSci139-101