A Study of TQB2102 for Injection in Patients With Recurrent/Metastatic Breast Cancer (NCT06115902) | Clinical Trial Compass
CompletedPhase 1
A Study of TQB2102 for Injection in Patients With Recurrent/Metastatic Breast Cancer
China153 participantsStarted 2023-11-17
Plain-language summary
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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Exclusion criteria
. Has diagnosed and/or treated additional malignancy within 3 years prior to first administration of study drug;
. Adverse effects due to any prior treatment have not been restored according to CommonTerminology Criteria for Adverse Events (CTCAE) 5.0 ≤ level 1 (Excluding hair loss);
. Major surgical treatment, incision biopsy, or significant traumatic injury received within 28 days prior to study treatment;
. Long-term unhealed wounds or fractures;
. Patients who have a prior history of interstitial lung disease/pneumonia requiring steroid intervention, or who are present with interstitial lung disease/pneumonia, or who are suspected of having interstitial lung disease/pneumonia on screening imaging and cannot be ruled out;
. Arterial/venous thrombosis events, such as cerebrovascular accident, deep vein thrombosis, and pulmonary embolism, occurred within 6 months before the first medication;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Overall Response Rate (ORR)
Timeframe: Baseline up to 10 months.
Trial details
NCT IDNCT06115902
SponsorChia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.