A Study of TQB2930 for Injection Monotherapy or Combination Therapy in Patients With Recurrent/Metastatic Breast Cancer
A Phase Ib/II Clinical Trial to Evaluate the Safety and Efficacy of TQB2930 for Injection Monotherapy or in Combination for the Treatment of Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Recurrent / Metastatic Breast Cancer
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
154 participants
Apr 13, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria11
- 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 Criteria16
- 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.
Interventions
TQB2930 for injection is a HER2 bispecific antibody.
It is an anti-microtubule chemotherapy drug
TQB3616 capsule is a Cyclin-dependent kinase 4/6 (CDK4/6) inhibitor.
Fulvestrant is a competitive estrogen receptor antagonist with similar affinity to estradiol
Capecitabine is converted to 5-fluorouracil (5-FU) by in vivo enzyme action.
Vinorelbine is an anti-tumor drug of vinca alkaloids.
Eribulin induces G2/M phase cell cycle arrest, mitotic spindle division, and ultimately apoptosis after prolonged mitotic arrest through its tubulin-based anti-mitotic mechanism.
Gemcitabine is a cell cycle specific anti-metabolic anticancer agent
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06202261