This is a multi-center, phase Ia/Ib, open clinical study to evaluate the safety and efficacy of TWP-101 in patients with advanced solid tumor. This study consists of two parts (Part A and Part B). Part A was a dose escalation study, and Part B was a dose expansion study.

Start Date30 Aug 2021

Sponsor / Collaborator

Therawisdom Biopharma Co., Ltd.

NCT04871334

/ Unknown statusPhase 1

A Multi-center, Phase Ia/Ib, Open Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of TWP-101 in Patients With Advanced Melanoma and Urothelial Carcinoma

This study is a multi-center, phase Ia/Ib, open clinical study to evaluate the safety, tolerability and pharmacokinetics of TWP-101 in patients with advanced melanoma and urothelial carcinoma. This study consists of two parts (Part A and Part B). Part A was a dose escalation study, and Part B was a dose expansion study.

Start Date07 Feb 2021

Sponsor / Collaborator

Therawisdom Biopharma Co., Ltd.

CTR20262182

/ Not yet recruitingPhase 1/2

评价IMM040811注射液联合IMM092注射液在晚期实体瘤受试者中的安全性、药代动力学、药效动力学、免疫原性和初步疗效的I/II期临床研究

[Translation] A Phase I/II clinical study evaluating the safety, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary efficacy of IMM040811 injection in combination with IMM092 injection in patients with advanced solid tumors.

主要目的：评价IMM040811注射液和IMM092注射液联合/不联合多西他赛注射液在晚期实体瘤受试者中的安全性和耐受性，确定II期推荐剂量（RP2D）；采用实体瘤疗效评价标准1.1版（RECIST V1.1）初步评价IMM040811注射液和IMM092注射液联合/不联合多西他赛注射液的抗肿瘤有效性。次要目的：评价IMM040811注射液联合IMM092注射液的药代动力学特征、免疫原性；采用实体瘤疗效评价标准1.1版（RECIST V1.1）初步评价IMM040811注射液和IMM092注射液联合/不联合多西他赛注射液的抗肿瘤有效性。探索性目的：采用iRECIST标准探索性评价IMM040811注射液和IMM092注射液联合不联合多西他赛注射液的抗肿瘤活性；探索IMM040811注射液联合IMM092注射液的药效学特征。

[Translation]

Primary Objective: To evaluate the safety and tolerability of IMM040811 injection and IMM092 injection, in combination with or without docetaxel injection, in patients with advanced solid tumors, and to determine the Phase II recommended dose (RP2D). To preliminarily evaluate the antitumor efficacy of IMM040811 injection and IMM092 injection, in combination with or without docetaxel injection, using RECIST version 1.1. Secondary Objectives: To evaluate the pharmacokinetic characteristics and immunogenicity of IMM040811 injection and IMM092 injection, in combination with or without docetaxel injection, using RECIST version 1.1. Exploratory objective: To evaluate the antitumor activity of IMM040811 injection and IMM092 injection in combination with or without docetaxel injection using iRECIST criteria; and to explore the pharmacodynamic characteristics of IMM040811 injection in combination with IMM092 injection.

Start Date-

Sponsor / Collaborator

Beijng Immunoah Pharma Tech Co., Ltd

100 Clinical Results associated with Sytalizumab

100 Translational Medicine associated with Sytalizumab

100 Patents (Medical) associated with Sytalizumab

100 Deals associated with Sytalizumab

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Malignant Solid Neoplasm	Phase 2	China	Beijng Immunoah Pharma Tech Co., Ltd	04 Jun 2026
Advanced Urothelial Carcinoma	Phase 1	China	Therawisdom Biopharma Co., Ltd.	07 Feb 2021
Locally Advanced Melanoma	Phase 1	China	Therawisdom Biopharma Co., Ltd.	07 Feb 2021
Urothelial Carcinoma of the Urinary Bladder	Phase 1	China	Therawisdom Biopharma Co., Ltd.	07 Feb 2021
Melanoma	Phase 1	China	Therawisdom Biopharma Co., Ltd.	30 Dec 2020
Transitional Cell Carcinoma	Phase 1	China	Therawisdom Biopharma Co., Ltd.	30 Dec 2020

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04871334 (ASCO 12023 \| ASCO 22023) Manual	Phase 1	Melanoma \| Transitional Cell Carcinoma	13	TWP-101	oouyuxgcub(dvajvzrldg) = wixgaxutjk ysuueqehzo (wewwmwgbhi ) View more	Positive	26 May 2023

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