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

NCT07512583 | Recruiting Phase 1

• 1 other identifier: TQB2930-TQB2102-Ib/II-01
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 3

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.

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (2)

• Recommended Phase 2 Dose

  Recommended Phase 2 Dose

  From first dose to 21days after first 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).

  The estimated duration was 23 months from enrollment of the first patient to 6 months after enrollment of the last patient

Secondary Outcomes (12)

• 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

Study Arms (1)

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.

Drug: TQB2930 injection+TQB2102 for injection

Interventions

TQB2930 injection+TQB2102 for injection DRUG

TQB2930 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).

TQB2930 injection+TQB2102 for injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• g/L ； Neutrophil absolute value (NEUT) ≥ 1.5 × 10 9/L; Platelet count (PLT)
• ×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/min (Using the standard Cockcroft Gault formula);
• Urine routine test shows a urine protein concentration of ≤ 1+; If urinary protein is ≥ 2+, it needs to be tested for 24 hours within 7 days Urine protein quantitative testing can only be selected when the 24-hour urine protein is less than 1g;
• Coagulation function: Prothrombin time (PT), activated partial thromboplastin time (APTT) International Normalized Ratio (INR) ≤ 1.5 × ULN;
• Cardiac function: Left ventricular ejection fraction ≥ 50%;

You may not qualify if:

• 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);
• Suffering from major cardiovascular diseases, including any of the following conditions:
• Cardiac insufficiency at or above New York Heart Association (NYHA) class II;
• History of clinically significant ventricular arrhythmias (such as persistent ventricular tachycardia, ventricular fibrillation, and torsade de pointes) or frequent and uncontrollable arrhythmias;
• Unstable angina pectoris, or severe stenosis and occlusion of the coronary artery;
• Suffered from myocardial infarction within 6 months;

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.: lead

Study Sites (3)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150000, China

NOT YET RECRUITING

Tianjin Medical University Cancer Institute&Hospital

Tianjin, Tianjin Municipality, 300060, China

NOT YET RECRUITING

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Binghe Xu, Doctor

CONTACT

13501028690; xubinghe@medmail.com.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2026
• First Posted: April 6, 2026
• Study Start: May 27, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: June 8, 2026

Record last verified: 2025-10

Locations

CN (3)