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A Study of TQB2930 for Injection Monotherapy or Combination Therapy in Patients With Recurrent/Metastatic Breast Cancer

NCT06202261 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 154

Last updated 2024-03-12

No results posted yet for this study

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).

Conditions

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

Sponsors & Collaborators

  • Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-13
Primary Completion
2026-12-31
Completion
2027-10-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06202261 on ClinicalTrials.gov