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A Study of TQB2102 for Injection in the Treatment of HER2-positive Biliary Tract Cancer

StatusRecruiting
PhasePhase 1/2
Started2024-07-22
View on ClinicalTrials.gov ↗

Amendment history

2026-04-02
Study Status, Study Design, Eligibility v4
Enrollment target103→102
Eligibility criteria+65 characters
Inclusion Criteria: 18 years ≤ age ≤75 years; Eastern Cooperative Oncology Group (ECOG) score 0 to 1; TestSubjects subjectsmust withprovide sufficient tumor tissue sample and confirm HER2 expressionpositivity orby amplificationcentral orlaboratory mutationprior requireto first dose, defined as immunohistochemistry of HER2(IHC) 3+ or HER2IHC 2+ and positive forwith in situ hybridization (ISH) positive; The main organs function well; Meet the criteria for advan [...] efficacy of solid tumors (RECIST) 1.1 criteria; Failure of previous1-2 standardprior treatment.lines of systemic therapy Women of reprod [...]
2025-12-12
Study Status, Contacts/Locations v3
Study sites23→43
2025-12-01
Study Status v2
Primary completion date2025-05→2027-05
Completion date2025-12→2029-12
Start dateestimated 2024-07→confirmed 2024-07-22
2024-07-26
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Study sites22→23
2024-05-22
Original filing
To evaluate the efficacy and safety TQB2102 for injection in the treatment of patients with Her2-positive biliary tract cancer.
Trial Details
NCT Number NCT06431490
Lead Sponsor Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
Conditions Biliary Tract Cancer
Enrollment 102 participants
Start Date 2024-07-22
Primary Completion 2027-05 (estimated)
Study Completion 2029-12 (estimated)
Updated on ClinicalTrials.gov 2026-04-08