NCT07099547 Study of ZG005 in Combination With Platinum-Based Chemotherapy in Participants With Advanced Biliary Tract Carcinoma
| NCT ID | NCT07099547 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Suzhou Zelgen Biopharmaceuticals Co.,Ltd |
| Condition | Biliary Tract Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-12-02 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 60 participants in total. It began in 2025-12-02 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a randomized, open-label, phase II study evaluating first-line treatment for advanced gallbladder cancer. It aims to assess the efficacy, safety, pharmacokinetics, and immunogenicity of the ZG005 in Combination with gemcitabine and cisplatin as first-line therapy in Participants with advanced gallbladder cancer.
Eligibility Criteria
Inclusion Criteria: * Fully understand the study and voluntarily sign the informed consent form. * Subjects with a histopathological or cytologically diagnosis of Gallbladder cancer. * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. * Life expectancy of at least 3 months. Exclusion Criteria: * Participants were deemed unsuitable for participating in the study by the investigator for any reasons.
Contact & Investigator
Jason Wu
STUDY CHAIR
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Frequently Asked Questions
Who can join the NCT07099547 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Biliary Tract Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07099547 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07099547 currently recruiting?
Yes, NCT07099547 is actively recruiting participants. Contact the research team at liub@zelgen.com for enrollment information.
Where is the NCT07099547 trial being conducted?
This trial is being conducted at Hefei, China.
Who is sponsoring the NCT07099547 clinical trial?
NCT07099547 is sponsored by Suzhou Zelgen Biopharmaceuticals Co.,Ltd. The principal investigator is Jason Wu at Suzhou Zelgen Biopharmaceuticals Co.,Ltd. The trial plans to enroll 60 participants.