NCT07512583
Not yet recruiting
Phase 1
Phase Ib/II Clinical Trial of TQB2930 Injection in Combination With TQB2102 for Injection in Patients With HER2-Expressing Advanced Solid Tumors
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.0 sites178 target enrollmentStarted: April 1, 2026Last updated:
ConditionsAdvanced Solid Tumor
InterventionsTQB2930 injection+TQB2102 for injection
Overview
- Phase
- Phase 1
- Status
- Not yet recruiting
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
- Enrollment
- 178
- Primary Endpoint
- Recommended Phase 2 Dose
Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 ；
Exclusion Criteria
- •Patients with known spinal cord compression or active central nervous system metastasis (defined as untreated or symptomatic metastasis, or requiring corticosteroids or anticonvulsants to control related symptoms) are excluded, unless they have been stable for at least 4 weeks after treatment (no new or expanding imaging evidence of brain metastasis) and have not used corticosteroids and anticonvulsants within 2 weeks before randomization.
- •Subjects with only cutaneous and/or intracranial lesions as target lesions.
- •Concurrent diseases and medical history:
- •Have had or currently have other malignant tumors within 5 years, except for the following conditions: cured carcinoma in situ of the cervix, non-melanoma skin cancer, and superficial bladder tumors \[Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor invades the basement membrane)\], differentiated thyroid cancer, and colorectal intra-mucosal cancer;
- •The adverse reactions from previous treatments have not recovered to a Common Terminology Criteria for Adverse Events Version (CTCAEv5.0) score of ≤1, except for Grade 2 alopecia, Grade 2 peripheral neurotoxicity, Grade 2 anemia, non-clinically significant and asymptomatic laboratory abnormalities, and stable hypothyroidism treated with hormone replacement therapy, which the investigator deems to pose
- •Those who have undergone major surgical treatment, significant traumatic injury, or are expected to undergo major surgery during the study treatment period (excluding surgeries specified in the protocol) within 4 weeks before the first dose, or have long-term unhealed wounds or fractures (excluding pathological fractures, but if there is severe bone damage in bone metastases and it may affect survival, it needs to be excluded). (Major surgery is defined as surgeries at or above level 3 in the National Surgical Classification Catalogue 2022 edition);
- •There are diseases that affect intravenous injection and venous blood sampling;
- •Subjects with congenital bleeding or coagulation dysfunction, or those who have experienced bleeding or coagulopathy within 28 days prior to the commencement of study treatment, or who have taken aspirin \>325 mg/day (the maximum antiplatelet dose) within 7 days prior to the commencement of study treatment;
- •Cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction, except for asymptomatic and non-treatment-required lacunar cerebral infarction) or pulmonary embolism occurred within 6 months before the first dose; currently, there is deep venous thrombosis requiring therapeutic intervention;
- •Poor blood pressure control (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg);
Arms & Interventions
TQB2930 injection+TQB2102 for injection
Experimental
TQB2930 injection: Intravenous infusion, administered once on Day 1 of each treatment cycle, 21 days as a treatment cycle.
TQB2102 for injection: Intravenous infusion, administered once on day 1 of each treatment cycle, 21 days as a treatment cycle.
Intervention: TQB2930 injection+TQB2102 for injection (Drug)
Outcomes
Primary Outcomes
Recommended Phase 2 Dose
Time Frame: From first dose to 21days after first dose
Recommended Phase 2 Dose
Overall response rate (ORR)
Time Frame: The estimated duration was 23 months from enrollment of the first patient to 6 months after enrollment of the last patient
After enrollment of all patients, the proportion of participants with the best overall efficacy rated as complete response or partial response according to criteria (RECIST1.1).
Secondary Outcomes
- Progression-free survival (PFS)(The estimated time from randomization to patient disease progression was 10 months)
- Duration of response (DOR)(The estimated duration was 27 months from enrollment of the first patient to 10 months after enrollment of the last patient)
- Disease control rate (DCR)(The estimated duration was 27 months from enrollment of the first patient to 10 months after enrollment of the last patient)
- Overall survival (OS)(From enrollment until patient death, it is expected to be evaluated up to 5 years)
- Number of patients with adverse events (AEs) and serious adverse events (SAEs)(Baseline up to 30 days after the last dose)
- AE/SAE severity(Baseline up to 30 days after the last dose)
- Complete response rate(The estimated duration was 23 months from enrollment of the first patient to 6 months after enrollment of the last patient)
- Cmax(60 minutes before and 15 minutes post TQB2102; 4, 8, 24, 48, 96, 168, 336, and 504 hours post TQB2930; cycles 4 and 6: 60 minutes before and 15 minutes post TQB2102, and 15 minutes post TQB2930; cycle 12: 60 minutes before TQB2102 (21 days a cycle))
- clearance rate (CL)(60 minutes before and 15 minutes post TQB2102; 4, 8, 24, 48, 96, 168, 336, and 504 hours post TQB2930; cycles 4 and 6: 60 minutes before and 15 minutes post TQB2102, and 15 minutes post TQB2930; cycle 12: 60 minutes before TQB2102 (21 days a cycle))
- T1/2(60 minutes before and 15 minutes post TQB2102; 4, 8, 24, 48, 96, 168, 336, and 504 hours post TQB2930; cycles 4 and 6: 60 minutes before and 15 minutes post TQB2102, and 15 minutes post TQB2930; cycle 12: 60 minutes before TQB2102 (21 days a cycle))
- Vz(60 minutes before and 15 minutes post TQB2102; 4, 8, 24, 48, 96, 168, 336, and 504 hours post TQB2930; cycles 4 and 6: 60 minutes before and 15 minutes post TQB2102, and 15 minutes post TQB2930; cycle 12: 60 minutes before TQB2102 (21 days a cycle))
- Area under the blood drug concentration time curve(60 minutes before and 15 minutes post TQB2102; 4, 8, 24, 48, 96, 168, 336, and 504 hours post TQB2930; cycles 4 and 6: 60 minutes before and 15 minutes post TQB2102, and 15 minutes post TQB2930; cycle 12: 60 minutes before TQB2102 (21 days a cycle))
Investigators
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