Status:
RECRUITING
A Study of TQB2930 for Injection Monotherapy or Combination Therapy in Patients With Recurrent/Metastatic Breast Cancer
Lead Sponsor:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Conditions:
Metastatic Breast Cancer
Recurrent Breast Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
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 ma...
Eligibility Criteria
Inclusion
- 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
- Advanced malignancies confirmed by cytology / histopathology, priority given to subjects with HER2 expression or amplification;
- Subjects with malignant tumors who have failed standard treatment or lack effective treatment;
- Confirmed presence of at least one evaluable lesion according to RECIST 1.1 criteria
- Phase II
- 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:
- Have not received systemic antitumor therapy for metastatic stage; Systemic use of endocrine therapy is permitted, but not exceed 2 lines;
- 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
- 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.
Key Trial Info
Start Date :
April 13 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
154 Patients enrolled
Trial Details
Trial ID
NCT06202261
Start Date
April 13 2023
End Date
October 1 2027
Last Update
March 12 2024
Active Locations (2)
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1
Affiliated Cancer Hospital of Chongqing University
Chongqing, Chongqing Municipality, China, 400000
2
Affiliated cancer hospital of harbin medical university
Harbin, Heilongjiang, China, 150001