Actively Recruiting
A Phase Ib/II Trial Evaluating Safety and Efficacy of TQB2930 Injection Alone or Combined for HER2-Positive Recurrent or Metastatic Breast Cancer
Led by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Updated on 2024-03-12
154
Participants Needed
2
Research Sites
43 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of TQB2930 for injection, a HER2 bispecific antibody, given alone or combined with other treatments in patients with recurrent or metastatic breast cancer expressing HER2. This phase Ib/II trial includes advanced malignancies, focusing on patients with a limited life expectancy and prior treatment failures. The study aims to find the best dose and observe the treatment's impact on tumor response and patient survival. The trial has multiple treatment groups. Phase Ib involves dose escalation and expansion of TQB2930 alone or in combination with drugs like paclitaxel (albumin-bound), TQB3616 capsule plus fulvestrant, or chemotherapy agents such as capecitabine, vinorelbine, eribulin, or gemcitabine. Dosages and treatment cycles vary: TQB2930 is given at 10, 20, or 30 mg/kg on weekly or biweekly schedules with cycles lasting 21 or 28 days. Phase II further assesses safety and efficacy using combinations determined from earlier results. Participants undergo regular evaluations including tumor imaging to measure remission rates, blood tests for drug levels and immune response, and monitoring for side effects over periods ranging from months to years. The primary outcomes include maximum tolerated dose, objective remission rate, and recommended phase II dose. Secondary outcomes monitor survival, disease control, adverse events, and drug concentration. The study runs until 2027, with ongoing safety and efficacy assessments throughout.
CONDITIONS
Brief Title
A Study of TQB2930 for Injection Monotherapy or Combination Therapy in Patients With Recurrent/Metastatic Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years old
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1
- Expected survival of more than 3 months
- For Phase Ib: Advanced malignancies confirmed by cytology or histopathology, priority to HER2 expression or amplification
- For Phase Ib: Patients who failed standard treatment or have no effective treatment options
- For Phase Ib: At least one evaluable lesion based on RECIST 1.1 criteria
- For Phase II: Hormone receptor-negative, HER2-positive breast cancer confirmed by cytology or histopathology with local recurrence or distant metastasis, unsuitable for curative surgery or radiotherapy
- For Phase II: No prior systemic antitumor therapy for metastatic stage; endocrine therapy allowed but not exceeding two lines
- For Phase II: At least one measurable lesion meeting RECIST 1.1 criteria
- Normal functioning of major organs
- Female participants of reproductive age agree to use contraception during the study and for 6 months after
- Negative pregnancy test within 7 days before enrollment and not lactating
- Male participants agree to use contraception during the study and for 6 months after
You will not qualify if you...
- Other malignant tumors diagnosed within 3 years prior to first dose
- Unresolved toxicity above CTCAE grade 1 from prior treatment
- Major surgery, open biopsy, or significant injury within 28 days before first dose
- Long-term unhealed wounds or fractures
- Arterial or venous thrombosis events within 6 months before first dose
- History of psychotropic drug abuse or ongoing mental disorders
- Severe or uncontrolled diseases
- Antitumor treatments such as chemotherapy, radiotherapy, or immunotherapy within 4 weeks prior to first dose
- Use of traditional Chinese medicine with antitumor effects within 2 weeks before first dose
- Severe bone injury due to bone metastasis
- Untreated active brain metastases, meningeal metastases, or cancerous meningitis
- Left Ventricular Ejection Fraction (LVEF) below 50% or decrease over 15% during prior HER2-targeted therapy
- Cumulative anthracycline dose exceeding 360 mg/m2
- Uncontrolled or symptomatic hypercalcemia requiring bisphosphonate therapy
- Severe hypersensitivity after monoclonal antibody use
- Participation in other antitumor clinical trials within 4 weeks prior to first dose
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years or until disease progression or discontinuation
Participants receive TQB2930 injection alone or in combination with other drugs as treatment for HER2-positive recurrent or metastatic breast cancer. Treatment cycles vary by regimen, including weekly, biweekly, or every three weeks dosing schedules with cycles lasting 21 or 28 days.
Weekly, biweekly, or every 3 weeks visits depending on treatment arm and cycle schedule
Duration - Up to 4 years
Participants are monitored for long-term outcomes including survival, disease progression, and safety after treatment ends.
Periodic visits for assessments during follow-up
Trial Site Locations
Total: 2 locations
1
Affiliated Cancer Hospital of Chongqing University
Chongqing, Chongqing Municipality, China, 400000
Actively Recruiting
2
Affiliated cancer hospital of harbin medical university
Harbin, Heilongjiang, China, 150001
Actively Recruiting
Research Team
Q
Qingyuan Zhang, Doctor
X
Xiaohua Zeng, Doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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