NCT06202261 A Study of TQB2930 for Injection Monotherapy or Combination Therapy in Patients With Recurrent/Metastatic Breast Cancer
| NCT ID | NCT06202261 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. |
| Condition | Metastatic Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 154 participants |
| Start Date | 2023-04-13 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 154 participants in total. It began in 2023-04-13 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a phase Ib/II exploratory study. Phase Ib includes the dose escalation and expansion study of monotherapy, as well as the dose escalation study of combination therapy. After determining the maximum tolerated dose (MTD), a dose expansion study is conducted to observe the safety and efficacy in monotherapy. Phase II study is to further observe the safety and efficacy of TQB2930 combined with albumin-paclitaxel (cohort 3), or chemotherapy selected by investigators (cohort 4).
Eligibility Criteria
Inclusion Criteria: * Age: 18-75 years old; Eastern Cooperative Oncology Group Performance Status (ECOG PS) score: 0\~1; The expected survival is over 3 months. * Phase Ib 1. Advanced malignancies confirmed by cytology / histopathology, priority given to subjects with HER2 expression or amplification; 2. Subjects with malignant tumors who have failed standard treatment or lack effective treatment; 3. Confirmed presence of at least one evaluable lesion according to RECIST 1.1 criteria * Phase II 1. Hormone receptor (HR)-negative, HER2-positive breast cancer confirmed by cytology / histopathology, with evidence of local recurrence or distant metastasis, unsuitable for surgery or radiotherapy for curative purposes: 2. Have not received systemic antitumor therapy for metastatic stage; Systemic use of endocrine therapy is permitted, but not exceed 2 lines; 3. at least one measurable lesion that meets the RECIST 1.1 criteria. * Major organs are functioning normally. * Female subjects of reproductive age should agree to use contraceptive methods during the study period and until 6 months after the end of the study; Negative serum pregnancy / urine pregnancy test within 7 days prior to study enrollment and must be non-lactating subjects; Male subjects should agree to use contraception during the study and until six months after the end of the study. Exclusion Criteria: * Have occured other malignant tumors within 3 years prior to first dose. * Unalleviated toxicity above Common Terminology Criteria for Adverse Events (CTCAE) grade 1 due to any prior treatment; * Received major surgical treatment, open biopsy, or significant traumatic injury within 28 days prior to the first dose; * Long-term unhealed wounds or fractures; * Arterial/venous thrombosis events occurred within 6 months before the first dose; * Have a history of psychotropic drug abuse and can't get rid of it or have mental disorders; * Subject with any severe and/or uncontrolled disease; * Subjects who have been treated with other antitumor agents such as chemotherapy, radiotherapy, or immunotherapy within 4 weeks prior to the first dose, within 5 half-lives of the drug; * Have used traditional chinese medicine with anti-tumor indications approved by National Medical Products Administration (NMPA) within 2 weeks before the first dose; * Severe bone injury due to bone metastasis; * Subjects with untreated active brain metastases or meningeal metastases or cancerous meningitis; * In the course of previous HER2-targeted therapy, Left Ventricular Ejection Fractions (LVEF) decreased to \<50% or absolute LVEF decreased \>15%; * Cumulative doses of anthracyclines exceeded doxorubicin or doxorubicin liposomes \>360 mg/m2; * Uncontrolled hypercalcemia or symptomatic hypercalcemia requires continued bisphosphonate therapy * Patients with severe hypersensitivity after the use of monoclonal antibodies; * Has participated in other antitumor clinical trials within 4 weeks prior to the first dose.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06202261 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Metastatic Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06202261 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06202261 currently recruiting?
Yes, NCT06202261 is actively recruiting participants. Contact the research team at sy86298276@163.com for enrollment information.
Where is the NCT06202261 trial being conducted?
This trial is being conducted at Chongqing, China, Harbin, China.
Who is sponsoring the NCT06202261 clinical trial?
NCT06202261 is sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.. The trial plans to enroll 154 participants.
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