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New treatment option for Advanced Solid Tumors
Official title GenSci139 in Patients With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT07230977
What this study is testing
What is GenSci139?
GenSci139 is an investigational medicine, being studied as a potential treatment for advanced solid tumors.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- 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...
- Is able to provide tumor tissues. Fresh biopsy specimens or archival tumor tissue samples obtained after last treatment are strongly preferred, and...
- Has at least one measurable lesion by RECIST v1.1.
You likely can't join if
- Any active malignancy within 3 years before initiation dose of GenSci139 except for the cancer under investigation in this study and any locally...
- 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...
- 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.
See the full eligibility 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Jinan, Shandong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jinan, Shandong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.