PDL1 inhibitors(Programmed death-ligand 1 inhibitors), VEGF inhibitors(Vascular endothelial growth factor inhibitors), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects)

Therapeutic Areas

Neoplasms

Active Indication

Advanced Malignant Solid Neoplasm

Inactive Indication-

Originator Organization

Zhongsheng Shangjian Biomedical (Hangzhou) Co., Ltd.

Active Organization

Zhongsheng Shangjian Biomedical (Hangzhou) Co., Ltd.

Inactive Organization-

Drug Highest PhasePhase 1

First Approval Date-

Regulation-

Clinical Trials associated with SG1408

CTR20222623 / RecruitingPhase 1

注射用SG1408在晚期恶性实体瘤受试者中安全性、耐受性和初步有效性的I期临床研究

[Translation] Phase I clinical study on the safety, tolerability and preliminary efficacy of SG1408 for injection in subjects with advanced malignant solid tumors

Ia期主要目的：1）安全性和耐受性；2）探索MTD或MAD。次要目的：1) 评估SG1408在晚期恶性实体瘤患者中PK特征；2) 评估SG1408在晚期恶性实体瘤患者中的PD特征；3) 评估SG1408免疫原性；4) 评价SG1408单药治疗的初步抗肿瘤疗效。探索性目的：1) 探索肿瘤组织/血液中SG1408潜在的生物标志物。 Ib期主要目的：1) 安全性和耐受性；2）确定RP2D；3）初步抗肿瘤疗效。。次要目的：1) 进一步评估SG1408在晚期恶性实体瘤患者中PK特征；2) 进一步评估SG1408在晚期恶性实体瘤患者中的PD特征；3) 进一步评估SG1408在晚期恶性实体瘤患者中的免疫原性。探索性目的：1) 探索肿瘤组织/血液中SG1408潜在的生物标志物。

[Translation]

The main objectives of Phase Ia: 1) Safety and tolerability; 2) Exploration of MTD or MAD. Secondary objectives: 1) Evaluate the PK characteristics of SG1408 in patients with advanced malignant solid tumors; 2) Evaluate the PD characteristics of SG1408 in patients with advanced malignant solid tumors; 3) Evaluate the immunogenicity of SG1408; 4) Evaluate the preliminary anti-tumor efficacy of SG1408 monotherapy. Exploratory objectives: 1) Explore potential biomarkers of SG1408 in tumor tissue/blood. The main objectives of Phase Ib: 1) Safety and tolerability; 2) Determine RP2D; 3) Preliminary anti-tumor efficacy. . Secondary objectives: 1) Further evaluate the PK characteristics of SG1408 in patients with advanced malignant solid tumors; 2) Further evaluate the PD characteristics of SG1408 in patients with advanced malignant solid tumors; 3) Further evaluate the immunogenicity of SG1408 in patients with advanced malignant solid tumors. Exploratory objectives: 1) Explore potential biomarkers of SG1408 in tumor tissue/blood.

Start Date10 Nov 2022

Sponsor / Collaborator

Zhongsheng Shangjian Biomedical (Hangzhou) Co., Ltd.

100 Clinical Results associated with SG1408

100 Translational Medicine associated with SG1408

100 Patents (Medical) associated with SG1408

100 Deals associated with SG1408

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Malignant Solid Neoplasm	Phase 1	CN	Zhongsheng Shangjian Biomedical (Hangzhou) Co., Ltd.	10 Nov 2022

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