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.
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;
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.
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
Single group
TQB2930 injection+TQB2102 for injection
DrugTQB2930 Injection is a Human Epidermal Growth Factor Receptor 2 (HER2) bispecific antibody. TQB2102 for injection is a HER2 - targeted dual epitope Antibody-Drug Conjugate (ADC).
Recommended Phase 2 Dose
Recommended Phase 2 Dose
Overall response rate (ORR)
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).
Progression-free survival (PFS)
Defined as the time from first dose to first occurrence of disease progression or death due to any cause.
Duration of response (DOR)
Patient from the date of first documentation of objective remission of the tumor to the date of first documentation of objective progression of the tumor or the date of death due to any cause.
Disease control rate (DCR)
Proportion of participants with complete response, partial response, and stable disease as rated by RECIST v1.1 criteria for best overall efficacy after enrollment of all patients..
Overall survival (OS)
The time from enrollment to death due to any cause.
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