Treatment with TQB2930 for advanced 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

This study is testing a new treatment called TQB2930 for people with advanced breast cancer to see if it is safe and effective, both on its own and when combined with other chemotherapy drugs.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 154 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy, doxorubicin
• Locations: 2 sites (Chongqing, Chongqing Municipality and 1 other locations)
• Trial ID: NCT06202261 on ClinicalTrials.gov

What this trial studies

This exploratory phase Ib/II study investigates the safety and efficacy of TQB2930, both as a monotherapy and in combination with other treatments, for patients with recurrent or metastatic breast cancer. The phase Ib portion focuses on determining the maximum tolerated dose (MTD) and includes dose expansion for monotherapy. The phase II portion evaluates TQB2930 combined with albumin-paclitaxel or other chemotherapy options. The study aims to provide insights into effective treatment options for patients who have not responded to standard therapies.

Who should consider this trial

Good fit: Ideal candidates are women aged 18-75 with hormone receptor-negative, HER2-positive breast cancer that has recurred or metastasized and who have not received systemic antitumor therapy for the metastatic stage.

Not a fit: Patients with early-stage breast cancer or those who have not yet received standard treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with advanced breast cancer who have limited treatment choices.

How similar studies have performed: Other studies have shown promise with similar approaches in targeting advanced breast cancer, indicating potential for success in this trial.

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

  1. Advanced malignancies confirmed by cytology / histopathology, priority given to subjects with HER2 expression or amplification;
  2. Subjects with malignant tumors who have failed standard treatment or lack effective treatment;
  3. Confirmed presence of at least one evaluable lesion according to RECIST 1.1 criteria
* Phase II

  1. 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:
  2. Have not received systemic antitumor therapy for metastatic stage; Systemic use of endocrine therapy is permitted, but not exceed 2 lines;
  3. 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.

Where this trial is running

Chongqing, Chongqing Municipality and 1 other locations

• Affiliated Cancer Hospital of Chongqing University — Chongqing, Chongqing Municipality, China (Recruiting)
• Affiliated cancer hospital of harbin medical university — Harbin, Heilongjiang, China (Recruiting)

Study contacts

• Study coordinator: Qingyuan Zhang, Doctor

Conditions Metastatic Breast Cancer; Recurrent Breast Cancer; Advanced Malignancies