[Translation] A phase I clinical study of dose escalation, tolerability, safety, and pharmacokinetics of ZGGS15 for injection in patients with advanced solid tumors.

主要目的：（1）评价 ZGGS15 的耐受性和安全性；（2）确认 ZGGS15 的最大耐受剂量（MTD），确定 II 期推荐剂量（RP2D）/后续试验推荐剂量。次要目的：（1）评价 ZGGS15 的人体药代动力学特征；（2）初步探索 ZGGS15 在实体瘤患者中的有效性；（3）评价 ZGGS15 的免疫原性。探索目的：（1）初步探索 ZGGS15 的药效学特征及生物标志物。

[Translation]

Primary objectives: (1) Evaluate the tolerability and safety of ZGGS15; (2) Confirm the maximum tolerated dose (MTD) of ZGGS15 and determine the recommended dose for Phase II (RP2D)/recommended dose for subsequent trials. Secondary objectives: (1) Evaluate the pharmacokinetic characteristics of ZGGS15 in humans; (2) Preliminary explore the efficacy of ZGGS15 in patients with solid tumors; (3) Evaluate the immunogenicity of ZGGS15. Exploration objectives: (1) Preliminary explore the pharmacodynamic characteristics and biomarkers of ZGGS15.

Start Date06 Jul 2023

Sponsor / Collaborator

Suzhou Zelgen Biopharmaceuticals Co., Ltd.

100 Clinical Results associated with ZGGS15

100 Translational Medicine associated with ZGGS15

100 Patents (Medical) associated with ZGGS15

Literatures (Medical) associated with ZGGS15

Scientific Reports

A novel anti-LAG-3/TIGIT bispecific antibody exhibits potent anti-tumor efficacy in mouse models as monotherapy or in combination with PD-1 antibody

Article

Author: Vicente-Suarez, Ildefonso ; Lv, Binhua ; Yu, Jifeng ; Zhang, Bin ; Sun, Hao ; Song, Yongping ; Jiang, Zhongxing ; Dai, Tongcheng ; Sheng, Jackie ; Liban, Tyler

AbstractWe report the generation of a novel anti-LAG-3/TIGIT bispecific IgG4 antibody, ZGGS15, and evaluated its anti-tumor efficacy in mouse models as monotherapy or in combination with a PD-1 antibody. ZGGS15 exhibited strong affinities for human LAG-3 and TIGIT, with KDs of 3.05 nM and 2.65 nM, respectively. ZGGS15 has EC50s of 0.69 nM and 1.87 nM for binding to human LAG-3 and TIGIT on CHO-K1 cells, respectively. ZGGS15 competitively inhibited the binding of LAG-3 to MHC-II (IC50 = 0.77 nM) and the binding of TIGIT to CD155 (IC50 = 0.24 nM). ZGGS15 does not induce ADCC, CDC, or obvious cytokine production. In vivo results showed that ZGGS15 had better anti-tumor inhibition than single anti-LAG-3 or anti-TIGIT agents and demonstrated a synergistic effect when combined with nivolumab, with a significantly higher tumor growth inhibition of 95.80% (p = 0.001). The tumor volume inhibition rate for ZGGS15 at 2 mg/kg was 69.70%, and for ZGGS15 at 5 mg/kg plus nivolumab at 1 mg/kg, it was 94.03% (p < 0.001). Our data reveal that ZGGS15 exhibits potent anti-tumor efficacy without eliciting ADCC or CDC or causing cytokine production, therefore having a safe profile.

100 Deals associated with ZGGS15

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Malignant Solid Neoplasm	Phase 1	China	Suzhou Zelgen Biopharmaceuticals Co., Ltd.	06 Jul 2023
Solid tumor	IND Approval	United States	Suzhou Zelgen Biopharmaceuticals Co., Ltd.	08 Jun 2023

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