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New treatment option for Metastatic Breast Cancer
Official title A Study of TQB2930 for Injection Monotherapy or Combination Therapy in Patients With Recurrent/Metastatic Breast Cancer
ClinicalTrials.gov ID: NCT06202261
What this study is testing
What is TQB2930 for injection?
TQB2930 for injection is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for metastatic breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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 people with HER2 expression or amplification;
- people 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
You likely can't join if
- 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;
See the full eligibility 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 people with HER2 expression or amplification;
- people 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 people 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...
- 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;
- people 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;
- people 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 \ 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.
The study team makes the final eligibility decision.
Where it's taking place
- Chongqing, Chongqing Municipality, China
- Harbin, Heilongjiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chongqing, Chongqing Municipality, China; Harbin, Heilongjiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.