A Phase 3, Multicenter, Randomized and Double-blind Study Assessing the Interchangeability Between TRS003 and China-approved Bevacizumab® (Also Called China-approved Avastin) For First-Line Treatment of Patients With Metastatic Colorectal Cancer (CRC)

This is a Phase 3, multicenter, randomized and double-blind study assessing the interchangeability between TRS003 and China-approved Bevacizumab® (also called China-approved Avastin) for first-line treatment of patients with metastatic Colorectal Cancer (CRC), approximately 126 patients will be enrolled in this study. Patients who sign the informed consent, meet the eligibility criteria and are confirmed as non-progressors after lead-in treatment period with Bevacizumab® in combination with modified FOLFOX6 chemotherapy for 6 cycles, will be randomized (1:1) to either the non-switching arm and receive Bevacizumab® + modified FOLFOX6 for all subsequent cycles or to the switching arm and receive TRS003 alternating with Bevacizumab® in combination with mFOLFOX6 until disease progression or intolerability.

Start Date01 Aug 2022

Sponsor / Collaborator

Zhejiang Teruisi Pharmaceutical Co., Ltd.

CTR20191049

/ RecruitingPhase 3

评估TRS003 与中国许可的贝伐珠单抗®分别联合紫杉醇-卡铂治疗晚期非鳞非小细胞肺癌（NSCLC）受试者的有效性及安全性一致性的多中心、随机、双盲、III 期研究

[Translation] A multicenter, randomized, double-blind, Phase III study to evaluate the efficacy and safety of TRS003 and China-licensed bevacizumab® in combination with paclitaxel-carboplatin in subjects with advanced non-squamous non-small cell lung cancer (NSCLC)

主要目的：证明TRS003与紫杉醇-卡铂联合用药在晚期非鳞非小细胞肺癌受试者中，在第19周时经研究者评估的客观缓解率（ORR）（根据RECIST1.1标准）与中国许可的贝伐珠单抗®类似。次要目的：1、评估TRS003和中国许可的贝伐珠单抗®分别联合紫杉醇-卡铂的缓解持续时间（DOR），无进展生存期（PFS）及总生存期（OS）。2、评估TRS003联合紫杉醇-卡铂和中国许可的贝伐珠单抗®联合紫杉醇-卡铂用药的安全性。3、评估TRS003和中国许可的贝伐珠单抗®的药代动力学（PK）。4、评估TRS003和中国许可的贝伐珠单抗®的免疫原性

[Translation]

Primary objective: To demonstrate that the objective response rate (ORR) assessed by investigators at week 19 (according to RECIST1.1 criteria) of TRS003 combined with paclitaxel-carboplatin in subjects with advanced non-squamous non-small cell lung cancer is similar to that of China-licensed bevacizumab®. Secondary objectives: 1. To evaluate the duration of response (DOR), progression-free survival (PFS) and overall survival (OS) of TRS003 and China-licensed bevacizumab® combined with paclitaxel-carboplatin, respectively. 2. To evaluate the safety of TRS003 combined with paclitaxel-carboplatin and China-licensed bevacizumab® combined with paclitaxel-carboplatin. 3. To evaluate the pharmacokinetics (PK) of TRS003 and China-licensed bevacizumab®. 4. To evaluate the immunogenicity of TRS003 and China-licensed bevacizumab®

Start Date17 Aug 2020

Sponsor / Collaborator

Zhejiang Teruisi Pharmaceutical Co., Ltd.

NCT04416035

/ Unknown statusPhase 3

A Phase 3, Multicenter, Randomized and Double-Blind Study to Assess the Similarity in Efficacy and Safety Between TRS003 and China-approved Bevacizumab in Subjects With Advanced Nonsquamous NSCLC

This is a double-blind Phase 3 clinical trial evaluating the efficacy and safety of TRS003 and paclitaxel-carboplatin versus China-approved bevacizumab and paclitaxel-carboplatin in patients with unresectable, locally advanced, or metastatic non-squamous non-small cell lung cancer (NSCLC). Approximately 608 patients will be enrolled in this study from America, Europe, and Asia. Patients who sign the informed consent and meet the inclusion criteria, will be randomized (1:1) to receive either TRS003 in combination with paclitaxel and carboplatin or China-approved bevacizumab in combination with paclitaxel and carboplatin for 4 to 6 cycles.

Start Date17 Aug 2020

Sponsor / Collaborator

Zhejiang Teruisi Pharmaceutical Co., Ltd.

100 Clinical Results associated with Recombinant humanized anti-VEGF monoclonal antibody(Teresi Pharmaceuticals)

100 Translational Medicine associated with Recombinant humanized anti-VEGF monoclonal antibody(Teresi Pharmaceuticals)

100 Patents (Medical) associated with Recombinant humanized anti-VEGF monoclonal antibody(Teresi Pharmaceuticals)

100 Deals associated with Recombinant humanized anti-VEGF monoclonal antibody(Teresi Pharmaceuticals)

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Lung Non-Small Cell Carcinoma	Phase 3	China	Zhejiang Teruisi Pharmaceutical Co., Ltd.	17 Aug 2020
Advanced Lung Non-Squamous Non-Small Cell Carcinoma	Phase 3	China	Zhejiang Teruisi Pharmaceutical Co., Ltd.	17 Aug 2020
Non-squamous non-small cell lung cancer	Phase 3	China	Zhejiang Teruisi Pharmaceutical Co., Ltd.	17 Aug 2020
Glioblastoma	Phase 3	China	Zhejiang Teruisi Pharmaceutical Co., Ltd.	-
Kidney Neoplasms	Phase 3	China	Zhejiang Teruisi Pharmaceutical Co., Ltd.	-
Liver Cancer	Phase 3	China	Zhejiang Teruisi Pharmaceutical Co., Ltd.	-
Metastatic Colorectal Carcinoma	Phase 3	China	Zhejiang Teruisi Pharmaceutical Co., Ltd.	-
Ovarian Cancer	Phase 3	China	Zhejiang Teruisi Pharmaceutical Co., Ltd.	-
Uterine Cervical Cancer	Phase 3	China	Zhejiang Teruisi Pharmaceutical Co., Ltd.	-

Clinical Result

Indication

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03882424 (CTgov)	Phase 1	-	114	TRS003 (TRS003)	bhjlexyagp(fenmcuzdjk) = zysrpouglz lbzlwzekih (shuyytukha, 4780171.58) View more	-	16 Jun 2020
				Bevacizumab (China-approved Bevacizumab)	bhjlexyagp(fenmcuzdjk) = tyfkrivuah lbzlwzekih (shuyytukha, 5232124.54) View more

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