RecruitingPhase 1Phase 2NCT06202261

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


Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Enrollment

154 participants

Start Date

Apr 13, 2023

Study Type

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial tests a new antibody-drug conjugate called TQB2930 — a treatment that delivers chemotherapy directly to cancer cells — alone or in combination, for people with breast cancer that has spread (metastatic) and has come back or stopped responding to prior therapy. **You may be eligible if...** - You have advanced or metastatic breast cancer that is HER2-positive and hormone receptor (HR)-negative - You have not yet received treatment for your metastatic disease (or no more than 2 lines of hormonal therapy) - You are between 18 and 75 years old - You have at least one measurable tumor on imaging - Your general health is adequate (ECOG 0–1) **You may NOT be eligible if...** - You have had another cancer in the last 3 years - You have cancer spread to the brain (active or untreated) - You have had major surgery, a blood clot, or significant injury in the last 28 days - You have serious heart disease - You are pregnant or breastfeeding - You received chemotherapy, radiation, or immunotherapy within 4 weeks of enrollment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTQB2930 for injection

TQB2930 for injection is a HER2 bispecific antibody.

DRUGPaclitaxel for injection (albumin-bound)

It is an anti-microtubule chemotherapy drug

DRUGTQB3616 capsule

TQB3616 capsule is a Cyclin-dependent kinase 4/6 (CDK4/6) inhibitor.

DRUGFulvestrant injection

Fulvestrant is a competitive estrogen receptor antagonist with similar affinity to estradiol

DRUGCapecitabine tablets

Capecitabine is converted to 5-fluorouracil (5-FU) by in vivo enzyme action.

DRUGVinorelbine tartrate injection

Vinorelbine is an anti-tumor drug of vinca alkaloids.

DRUGEribulin 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.

DRUGgemcitabine hydrochloride for injection

Gemcitabine is a cell cycle specific anti-metabolic anticancer agent


Locations(2)

Affiliated Cancer Hospital of Chongqing University

Chongqing, Chongqing Municipality, China

Affiliated cancer hospital of harbin medical university

Harbin, Heilongjiang, China

View Full Details on ClinicalTrials.gov

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NCT06202261


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