Symptoms and General Pathology

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Recurrence

Breast Neoplasms

Breast Diseases

Skin Diseases

Disease Attributes

Antineoplastic Agents

All Drugs and Chemicals

Reproductive Control Agents

Gemcitabine

Paclitaxel

Albumin-Bound Paclitaxel

Estradiol

Fluorouracil

Antibodies

Capecitabine

Vinorelbine

Fulvestrant

Estrogens

Antibodies, Bispecific

Immunoglobulins

Estradiol 17 beta-cypionate

Estradiol 3-benzoate

Polyestradiol phosphate

Mitogens

Vinca Alkaloids

Antimitotic Agents

Estrogen Antagonists

Estrogen Receptor Antagonists

Tubulin Modulators

Antimetabolites

Antineoplastic Agents, Hormonal

Hormones

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.

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

TQB3616 capsule:

180mg was given orally with meals or within 2 hours after meals, once a day， every 28 days for a cycle.

Fulvestrant injection:

500mg intramuscular injection was administered on day 1, every 28 days for a cycle, for the first cycle, was administered on day 1 and day 15

Placebo capsules:

0mg was given orally with meals or within 2 hours after meals, once a day, every 28 days for a cycle.

Fulvestrant injection:

500mg intramuscular injection was administered on day 1, every 28 days for a cycle, for the first cycle, was administered on day 1 and day 15

TQB3616 capsule is a CDK (cyclin-dependent kinases) 4/6 kinase inhibitor, which can selectively inhibit THE activity of CDK4/6 kinase, make it form a complex with Cyclin D, reduce the phosphorylation level of retinoblastoma protein (Rb) in cancer cells, and prevent cells from entering S phase from G1 phase

Placebo

Fulvestrant is a competitive estrogen receptor antagonist, and its mechanism is related to the down-regulation of estrogen receptor (ER) protein level

A randomized, double-blind, parallel-controlled, multicenter trial design was used in this study. Subjects who meet the criteria will be randomly divided into 2:1 groups to receive TBQ3616 capsule combined with Fulvestrant injection (experimental group) or placebo capsule combined with fulvestrant (control group). A total of 428 subjects were required.

To Evaluate the Efficacy and Safety of TQB3616 in Combination With Fulvestrant Versus Placebo in Combination With Fulvestrant in Previously Untreated Hormone-receptor (HR)-Positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Advanced Breast Cancer

A Randomized, Double-blind, Parallel-controlled Phase III Trial Evaluating the Efficacy and Safety of TQB3616 in Combination With Fulvestrant Versus Placebo in Combination With Fulvestrant in Previously Untreated HR-positive, HER2-negative Advanced Breast Cancer

The time from enrollment to the date of the first documentation of objective progression of disease or death due to any cause, whichever occurs first.

Overall survival was defined as the time from randomization to death from any cause.

The percentage of participants of survival above 3 years

Calculated as the percentage of participants with best overall response of CR, PR, stable disease (SD) and Non-CR/Non-progressive disease (PD).

The time from the date of participants with a first overall response defined as complete response (CR) or partial response (PR) to the date of the first documentation of objective progression of disease or death due to any cause, whichever occurs first.

Sense of satisfaction, life quality of participants since the enrollment of the study

Rare Diseases

Liposarcoma

Neoplasms, Adipose Tissue

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Sarcoma

Soft Tissue Sarcoma

TQB3616 capsule (180mg, quaque die, oral), 4 weeks (28 days) as a treatment cycle.

TQB3616 placebo (0mg, quaque die, oral), 4 weeks (28 days) as a treatment cycle.

TQB3616 capsule is a cyclin-dependent kinase 4/6 kinase inhibitor

TQB3616 placebo

Yuhong Zhou, Doctor

Shikai Wu, Doctor

Wei Guo, Doctor

A clinical trial evaluating TQB3616 capsules versus placebo in the treatment of dedifferentiated liposarcoma. Divided into 2 stages, the second stage, a total of 118 subjects are planned to be enrolled.

TQB3616 Capsules in the Treatment of Dedifferentiated Liposarcoma

A Randomized, Double-blind, Placebo-controlled, Multicenter Phase II Clinical Trial of TQB3616 Capsules Versus Placebo in the Treatment of Dedifferentiated Liposarcoma

From randomization to the time of disease progression or death, whichever occurs first.

For subjects whose best remission is complete remission or partial remission , it is defined as from the date when tumor remission is first recorded to the date when disease progression is first recorded or the date of death from any cause, whichever occurs first.

Percentage of complete or partial remission subjects as determined by RECIST 1.1.

Percentage of subjects with complete remission, partial remission, or disease stabilization at 6 weeks or more as determined by RECIST 1.1.

From the beginning of the crossover to the time of disease progression or death, whichever is first discovered

All adverse medical events that occurred after the subject received the investigational drug.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
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.
To Evaluate the Efficacy and Safety of TQB3616 in Combination With Fulvestrant Versus Placebo in Combination With Fulvestrant in Previously Untreated Hormone-receptor (HR)-Positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Advanced Breast Cancer	NCT05365178	HR-positive, HE...	TQB3616 capsule Placebo Fulvestrant inj...	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.
TQB3616 Capsules in the Treatment of Dedifferentiated Liposarcoma	NCT05496569	Dedifferentiate...	TQB3616 capsule TQB3616 placebo	18 Years - 75 Years	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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