OncoMatch/Clinical Trials/NCT06115902
A Study of TQB2102 for Injection in Patients With Recurrent/Metastatic Breast Cancer
Is NCT06115902 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies TQB2102 for for breast cancer.
Treatment: TQB2102 for — TQB2102 is an antibody-drug conjugate comprised of a humanised antibody against Human Epidermal Growth Factor Receptor 2 (HER2), an enzyme-cleavable linker, and a topoisomerase I inhibitor payload, which combine the ability of antibodies to specifically target tumour cells with the highly potent killing activity of drugs with payloads too toxic for systemic administration. This is a Phase 1/Phase 2 study to evaluate the effectiveness, safety, pharmacokinetics (PK) and anti-drug antibody (ADA) of TQB2102 for injection in subjects with HER2-expressing relapsed/metastatic breast cancer.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) expression
Breast cancer patients diagnosed with HER2 expression by pathological examination
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Must have received: any prior antitumor therapy
Disease progression or intolerance during or after the most recent treatment period must be present before participating in clinical trials
Cannot have received: chemotherapy
Patients who have been treated with other antitumor drug, such as chemotherapy, radical radiotherapy, or immunotherapy, within 4 weeks prior to the first dose, or who are still within 5 half-lives of the drug
Cannot have received: radical radiotherapy
Patients who have been treated with other antitumor drug, such as chemotherapy, radical radiotherapy, or immunotherapy, within 4 weeks prior to the first dose, or who are still within 5 half-lives of the drug
Cannot have received: immunotherapy
Patients who have been treated with other antitumor drug, such as chemotherapy, radical radiotherapy, or immunotherapy, within 4 weeks prior to the first dose, or who are still within 5 half-lives of the drug
Cannot have received: Chinese patent drugs with anti-tumor indications
Received Chinese patent drugs with anti-tumor indications specified in the National Medical Products Administration (NMPA) approved drug instructions within 2 week before the study treatment
Cannot have received: other anti-tumor clinical trial therapy
Patients who participated in and used other anti-tumor clinical trials within 4 weeks before the first medication
Lab requirements
Blood counts
Kidney function
Liver function
The main organs function are normally
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT06115902 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior chemotherapy, radical radiotherapy, immunotherapy disqualifies patients from enrollment.
Does this trial require ERBB2?
Yes, ERBB2 expression is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages