Recruiting NCT06202261
A Study of TQB2930 for Injection Monotherapy or Combination Therapy in Patients With Recurrent/Metastatic Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: TQB2930 for injection, Paclitaxel for injection (albumin-bound), TQB3616 capsule, Fulvestrant injection.
- Who it may be relevant to
- Registry conditions: Metastatic Breast Cancer, Recurrent Breast Cancer, Advanced Malignancies. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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).
Interventions
- Drug TQB2930 for injection
TQB2930 for injection is a HER2 bispecific antibody. - Drug Paclitaxel for injection (albumin-bound)
It is an anti-microtubule chemotherapy drug - Drug TQB3616 capsule
TQB3616 capsule is a Cyclin-dependent kinase 4/6 (CDK4/6) inhibitor. - Drug Fulvestrant injection
Fulvestrant is a competitive estrogen receptor antagonist with similar affinity to estradiol - Drug Capecitabine tablets
Capecitabine is converted to 5-fluorouracil (5-FU) by in vivo enzyme action. - Drug Vinorelbine tartrate injection
Vinorelbine is an anti-tumor drug of vinca alkaloids. - Drug Eribulin mesylate injection
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. - Drug gemcitabine hydrochloride for injection
Gemcitabine is a cell cycle specific anti-metabolic anticancer agent
Primary outcome measures
- Maximum tolerated dose (MTD) [Time frame: Baseline up to 4 months]
- Phase II recommended dose (P2RD) [Time frame: Baseline up to 1 year]
- Investigators assessed Objective remission rate (ORR) based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 [Time frame: Baseline up to 2 year]
Secondary outcome measures (12)
- Immunogenicity [Time frame: Pre-dose on Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, Cycle 7 Day 1, Cycle 12 Day 1, each cycle is 21 or 28 days.]
- Peak concentration (Cmax), QW [Time frame: Pre-dose, 30 minuets, 4, 8, 24, 48, 72 hours after dose on Cycle 1 Day 1, Cycle 2 Day 1; Pre-dose on Cycle 1 Day 8, Cycle 1 Day 15, Cycle 2 Day 8, each cycle is 21 days.]
- Peak concentration (Cmax), Q2W [Time frame: Pre-dose, 30 minuets, 4, 8, 24, 48, 72, 168, 240 hours after dose on Cycle 1 Day 1, Cycle 2 Day 1; Pre-dose on Cycle 1 Day 15, Cycle 2 Day 15, each cycle is 28 days.]
- Peak concentration (Cmax), Q3W [Time frame: Pre-dose, 30 minuets, 4, 8, 24, 48, 72, 168, 240, 336 hours after dose on Cycle 1 Day 1, Cycle 2 Day 1; Pre-dose on Cycle 3 Day 1, each cycle is 21 days.]
- Overall survival (OS) [Time frame: Baseline up to 4 years]
- Adverse event rate [Time frame: Baseline up to 2 years]
- Progression-free survival (PFS) [Time frame: Baseline up to 1 year]
- Disease control rate (DCR) [Time frame: Baseline up to 2 years]
- Duration of remission (DOR) [Time frame: Baseline up to 2 years]
- Clinical benefit rate (CBR) [Time frame: Baseline up to 2 years]
- Peak concentration (Cmax), arm 2 [Time frame: Pre-dose, 30 minuets after dose of Cycle 1 Day 1,Cycle 2 Day 1, Cycle 4 Day 1,Cycle 7 Day 1,Cycle 12 Day 1,Cycle 17 Day 1. each cycle is 28 days.]
- Peak concentration (Cmax), arm 3 and 4 [Time frame: Pre-dose, 30 minuets after dose of Cycle 1 Day 1,Cycle 2 Day 1, Cycle 4 Day 1,Cycle 7 Day 1,Cycle 12 Day 1,Cycle 17 Day 1. each cycle is 21 days.]
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
- 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 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 2 centers
- Affiliated Cancer Hospital of Chongqing University — Chongqing
- Affiliated cancer hospital of harbin medical university — Harbin
Identifiers
NCT: NCT06202261 · TQB2930-Ib/II-01