Clinical Studies of TQB2930 Injection for the Treatment of Advanced Solid Tumors (NCT07512583) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
Clinical Studies of TQB2930 Injection for the Treatment of Advanced Solid Tumors
178 participantsStarted 2026-04
Plain-language summary
This is a multicenter, open-label, multi-cohort phase Ib/II clinical study to evaluate the efficacy and safety of TQB2930 in combination with TQB2102 in patients with HER2-expressing advanced solid tumors.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* The subjects voluntarily joined this study, signed an informed consent form, and had good compliance;
* Age between 18 and 75 years old (calculated based on the date of signing the informed consent form);
* Eastern Cooperative Oncology Group (ECOG) score from 0 to 1;
* Expected survival is greater than 12 weeks;
* Advanced solid tumors with HER2 expression confirmed by histopathological/cytological examination. HER2 expression includes HER2 positive (including Immunohistochemistry (IHC) 3+, IHC 2+and Fish positive), HER2 low expression (including IHC 1+ IHC 2+and Fish negative, HC 0 but with HER2 expression);
* Confirm the presence of at least one measurable lesion according to RECIST 1.1 criteria;
* The laboratory inspection meets the following standards:
* Blood routine: Hemoglobin (HGB) levels in the past 14 days without the use of growth factors or blood transfusions
* 90g/L ; Neutrophil absolute value (NEUT) ≥ 1.5 × 10 9/L; Platelet count (PLT)
* 100×10 9 /L ;
* Liver function: For patients without liver metastasis, total bilirubin (TBIL) is ≤ 1.5 times the upper limit of normal (ULN), For patients with liver metastasis, total bilirubin (TBIL) ≤ 3.0 times the upper limit of normal (ULN); Alanine group Transferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN. If accompanied by liver transformation Move, then ALT and AST ≤ 5 × ULN;
* Renal function: Serum creatinine (CR) ≤ 1.5 × ULN or creatinine clearance rate (CCr) ≥ 60 ml…
What they're measuring
1
Recommended Phase 2 Dose
Timeframe: From first dose to 21days after first dose
2
Overall response rate (ORR)
Timeframe: The estimated duration was 23 months from enrollment of the first patient to 6 months after enrollment of the last patient
Trial details
NCT IDNCT07512583
SponsorChia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.