Actively Recruiting
A Study of TQB2930 for Injection Monotherapy or Combination Therapy in Patients With Recurrent/Metastatic Breast Cancer
Led by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Updated on 2024-03-12
154
Participants Needed
2
Research Sites
233 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official 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 with ECOG Performance Status 0 or 1 and expected survival over 3 months
- For phase Ib: Advanced malignancies confirmed by cytology or histopathology, especially with HER2 expression or amplification
- For phase Ib: Malignant tumors with failed standard treatment or lacking effective options
- For phase Ib: At least one measurable lesion by RECIST 1.1 criteria
- For phase II: Hormone receptor-negative, HER2-positive breast cancer with local recurrence or distant metastasis not suitable for curative surgery or radiotherapy
- For phase II: No prior systemic antitumor therapy for metastatic stage; endocrine therapy allowed up to 2 lines
- For phase II: At least one measurable lesion by RECIST 1.1 criteria
- Normal major organ function
- Female participants of reproductive age must agree to use contraception during and 6 months after the study and have a negative pregnancy test within 7 days before enrollment; must not be lactating
- Male participants must agree to use contraception during and 6 months after the study
You will not qualify if you...
- Other malignant tumors within 3 years before first dose
- Unresolved toxicity above CTCAE grade 1 from prior treatments
- Major surgery, open biopsy, or serious injury within 28 days before first dose
- Long-term unhealed wounds or fractures
- Arterial or venous thrombosis within 6 months before first dose
- History of psychotropic drug abuse or uncontrolled mental disorders
- Severe or uncontrolled diseases
- Antitumor treatments (chemotherapy, radiotherapy, immunotherapy) within 4 weeks or within 5 half-lives of the drug before first dose
- Use of traditional Chinese medicine with antitumor effects within 2 weeks before first dose
- Severe bone injury from bone metastasis
- Untreated active brain metastases, meningeal metastases, or cancerous meningitis
- Heart function with Left Ventricular Ejection Fraction below 50% or decreased by more than 15% during previous HER2 therapy
- Cumulative anthracycline dose above 360 mg/m2
- Uncontrolled or symptomatic hypercalcemia requiring bisphosphonate therapy
- Severe hypersensitivity to monoclonal antibodies
- Participation in other antitumor clinical trials within 4 weeks before first dose
AI-Screening
AI-Powered Screening
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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
CONTACT
X
Xiaohua Zeng, Doctor
CONTACT
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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