Clinical Studies of TQB2930 Injection for the Treatment of Advanced Solid Tumors

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorChia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

About this trial

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.

Eligibility criteria

Qualifiers

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;

Disqualifiers

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

Trial design

Treatments tested in this trial

  • TQB2930 injection+TQB2102 for injection

Treatment groups

178 Participants
are divided into 1 treatment group