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Gemcitabine

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Hormone Antagonists

TQB2930 for injection,10 mg/kg, quaque week (QW), 21 day as a treatment cycle; TQB2930 for injection, 20 mg/kg, quaque 2 weeks (Q2W), 28 day as a treatment cycle; TQB2930 for injection,30 mg/kg, quaque 3 weeks (Q3W), 21 day as a treatment cycle.

TQB2930 for injection 30mg/kg combined with paclitaxel (albumin-bound) for injection, 21 days for one treatment cycle

TQB2930 for injection 20mg/kg combined with TQB3616 capsule 120mg or 150mg or 180mg, and fulvestrant injection. Q2W, 28 days a cycle.

TQB2930 for injection 30mg/kg combined with capecitabine tablets or vinorelbine tartrate injection or eribulin mesylate injection or gemcitabine hydrochloride for injection, 21 days a cycle.

TQB2930 for injection is a HER2 bispecific antibody.

TQB2930 for injection

It is an anti-microtubule chemotherapy drug

Paclitaxel for injection (albumin-bound)

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

TQB3616 capsule

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

Fulvestrant injection

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

Capecitabine tablets

Vinorelbine is an anti-tumor drug of vinca alkaloids.

Vinorelbine tartrate 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.

Eribulin mesylate injection

Gemcitabine is a cell cycle specific anti-metabolic anticancer agent

gemcitabine hydrochloride for injection

Qingyuan Zhang, Doctor

Xiaohua Zeng, Doctor

Xiaohua Zeng

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).

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

The highest dose when dose-limiting toxicity (DLT) occurs in less than 33% of subjects.

Optimal tolerated dose determined after the end of phase 1

The proportion of subjects with complete response (CR) and partial response (PR) whose tumor volume reduced to a predetermined value and maintained the minimum time limit.

The maximum serum concentration after administration

From randomization to the time of death from any cause.

The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).

The time between the first medication and disease progression (PD) or death before PD.

The ratio of disease control cases (partial remission, complete response, stable disease) to total cases.

The time from the first evaluation of the tumor as a complete or partial response to the first evaluation as tumor progression or death.

The ratio of disease control cases (partial remission, complete response, stable disease ≥ 6 month) to total cases.

The maximum serum concentration after administration in arm 2

The maximum serum concentration after administration in arm 3 and 4.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study of TQB2930 for Injection Monotherapy or Combination Therapy in Patients With Recurrent/Metastatic Breast Cancer	NCT06202261	Metastatic Brea... Recurrent Breas... Advanced Malign...	TQB2930 for inj... Paclitaxel for ... TQB3616 capsule Fulvestrant inj... Capecitabine ta... Vinorelbine tar... Eribulin mesyla... gemcitabine hyd...	18 Years - 75 Years	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
A Study of TQB2930 for Injection Monotherapy or Combination Therapy in Patients With Recurrent/Metastatic Breast Cancer	NCT06202261	Metastatic Brea... Recurrent Breas... Advanced Malign...	TQB2930 for inj... Paclitaxel for ... TQB3616 capsule Fulvestrant inj... Capecitabine ta... Vinorelbine tar... Eribulin mesyla... gemcitabine hyd...	18 Years - 75 Years	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Spots Global Cancer Trial Database for tqb2930 for injection