IAP antagonists(Inhibitors of apoptosis (IAP) protein family antagonists), XIAP inhibitors(Inhibitor of apoptosis protein 3 inhibitors), cIAP1/cIAP2 inhibitors(cIAP1/cIAP2 inhibitors)

Therapeutic Areas

NeoplasmsRespiratory DiseasesImmune System Diseases+ [1]

Active Indication

Head and Neck NeoplasmsLocally Advanced Lung Non-Small Cell CarcinomaAdvanced cancer+ [2]

Inactive Indication

Advanced Malignant Solid Neoplasm

Originator Organization

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Active Organization

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

WuXi AppTec (Shanghai) Co. Ltd.

WuXi AppTec (Wuhan) Co., Ltd.

Inactive Organization-

Drug Highest PhasePhase 1/2

First Approval Date-

Regulation-

Clinical Trials associated with TQB-3728

CTR20233304 / RecruitingPhase 1/2

评估TQB3728 片在局部晚期头颈部肿瘤同期放化疗患者中有效性和安全性的随机、开放、平行对照、多中心Ib/II 期临床试验。

[Translation] A randomized, open-label, parallel-controlled, multicenter Phase Ib/II clinical trial to evaluate the efficacy and safety of TQB3728 tablets in patients with locally advanced head and neck tumors receiving concurrent chemoradiotherapy.

Ib期剂量递增阶段：主要目的评价TQB3728片在非手术治疗的局部晚期头颈部肿瘤同期放化疗患者的安全性和耐受性，并确定II期推荐剂量（RP2D）次要目的评价TQB3728片在非手术治疗的局部晚期头颈部肿瘤同期放化疗患的初步疗效，以及口服给药的药代动力学（PK）特征 II期剂量扩展阶段：主要目的评价TQB3728片在非手术治疗的局部晚期头颈鳞癌（SCCHN）同期放化疗患者中初步疗效次要目的评价TQB3728片在非手术治疗的局部晚期头鳞癌（SCCHN）同期放化疗患者中的安全性探索性目的探索TQB3728片治疗非手术治疗的局部晚期头颈腺癌同期放化疗患者中初步疗效和安全性

[Translation]

Phase Ib dose escalation phase: Primary purpose To evaluate the safety and tolerability of TQB3728 tablets in patients with non-surgical treatment of locally advanced head and neck tumors undergoing concurrent chemoradiotherapy, and to determine the Phase II recommended dose (RP2D) Secondary purpose To evaluate the preliminary efficacy of TQB3728 tablets in patients with non-surgical treatment of locally advanced head and neck tumors undergoing concurrent chemoradiotherapy, as well as the pharmacokinetic (PK) characteristics of oral administration Phase II dose expansion phase: Primary purpose To evaluate the preliminary efficacy of TQB3728 tablets in patients with non-surgical treatment of locally advanced head and neck squamous cell carcinoma (SCCHN) undergoing concurrent chemoradiotherapy Secondary purpose To evaluate the safety of TQB3728 tablets in patients with non-surgical treatment of locally advanced head and neck squamous cell carcinoma (SCCHN) undergoing concurrent chemoradiotherapy Exploratory purpose To explore the preliminary efficacy and safety of TQB3728 tablets in patients with non-surgical treatment of locally advanced head and neck adenocarcinoma undergoing concurrent chemoradiotherapy

Start Date19 Oct 2023

Sponsor / Collaborator

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

NCT05859373 / Not yet recruitingPhase 1/2

A Randomized, Open Label, Parallel Controlled, Multicenter Phase Ib/II Clinical Trial to Evaluate the Efficacy and Safety of TQB3728 Tablets in Sequential Maintenance of TQB2450 Injection Therapy in Patients After Sequential or Concurrent Chemoradiation for Locally Advanced Non-small Cell Lung Cancer.

It's a Phase Ib/II clinical trial to evaluate the efficacy and safety of TQB3728 tablets in sequential maintenance TQB2450 injection therapy in patients after sequential or concurrent chemoradiation for locally advanced non-small cell lung cancer.
Incidence and severity of adverse events (AEs), the type of dose-limiting toxicity(ies) (DLT[s]) and Recommended phaseII dose(RP2D) were the Phase Ib primary endpoint. Overall response rate (ORR) was the Phase II primary endpoint.

Start Date01 Jun 2023

Sponsor / Collaborator

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

NCT04523285 / Unknown statusPhase 1

A Phase I, Open-label, Dose Escalation and Expansion Study to Evaluate the Tolerance, and Pharmacokinetics of TQB3728 Tablets

This is a open-label, phase I study to evaluate tolerance and pharmacokinetics of TQB3728 tablets in subjects with advanced solid tumor or hematologic tumor.

Start Date26 Oct 2020

Sponsor / Collaborator

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

100 Clinical Results associated with TQB-3728

100 Translational Medicine associated with TQB-3728

100 Patents (Medical) associated with TQB-3728

100 Deals associated with TQB-3728

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Head and Neck Neoplasms	Phase 2	CN	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	19 Oct 2023
Locally Advanced Lung Non-Small Cell Carcinoma	Phase 2	CN	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	01 Jun 2023
Advanced Malignant Solid Neoplasm	Phase 1	CN	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	26 Oct 2020
Hematologic Neoplasms	Phase 1	CN	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	26 Oct 2020
Advanced cancer	Phase 1	CN	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	27 Aug 2020
Lymphoma	Phase 1	CN	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	27 Aug 2020
Neoplasms	Preclinical	CN	WuXi AppTec (Shanghai) Co. Ltd.	01 Jul 2019
Neoplasms	Preclinical	CN	WuXi AppTec (Wuhan) Co., Ltd.	01 Jul 2019

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04523285 (ASCO2024) Manual	Phase 1	Advanced Malignant Solid Neoplasm	23	TQB3728 25mg	ykhgaiuuep(blswyzazhd) = Not observed hroifvfopt (argqjirisg ) View more	Negative	24 May 2024
				TQB3728 100-200mg

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TQB-3728

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