[Translation] A Phase I clinical study evaluating the safety and tolerability of GTA182 in subjects with MTAPnull/lost advanced solid tumors through dose escalation and expansion

Ia期（剂量递增阶段）（1）主要目的：评估GTA182在MTAPnull/lost晚期实体瘤受试者中的安全性和耐受性，以确定扩展期推荐剂量（RDEs）或最大耐受剂量（MTD）（如存在）。（2）次要目的：评估GTA182在MTAPnull/lost晚期实体瘤受试者中的药代动力学特征；评估GTA182在MTAPnull/lost晚期实体瘤受试者中的初步有效性。（3）探索性目的：探索与GTA182疗效相关的生物标志物。Ib期（剂量扩展阶段）（1）主要目的：评估在RDEs剂量下GTA182在MTAPnull/lost晚期实体瘤受试者中的安全性和耐受性，以确认II期推荐剂量（RP2D）。（2）次要目的：评估在RDEs剂量下GTA182在MTAPnull/lost晚期实体瘤受试者中的药代动力学特征；评估在RDEs剂量下GTA182在MTAPnull/lost晚期实体瘤受试者中的初步有效性，为后续临床试验推荐剂量和适应症选择提供依据。（3）探索性目的：探索与GTA182疗效相关的生物标志物。

[Translation]

Phase Ia (dose escalation phase) (1) Primary objective: To evaluate the safety and tolerability of GTA182 in subjects with MTAPnull/lost advanced solid tumors to determine the recommended dose (RDEs) or maximum tolerated dose (MTD) for the extension phase (if any). (2) Secondary objectives: To evaluate the pharmacokinetic characteristics of GTA182 in subjects with MTAPnull/lost advanced solid tumors; To evaluate the preliminary efficacy of GTA182 in subjects with MTAPnull/lost advanced solid tumors. (3) Exploratory objective: To explore biomarkers associated with the efficacy of GTA182. Phase Ib (dose expansion phase) (1) Primary objective: To evaluate the safety and tolerability of GTA182 in subjects with MTAPnull/lost advanced solid tumors at the RDEs dose to confirm the recommended dose for Phase II (RP2D). (2) Secondary objectives: To evaluate the pharmacokinetic characteristics of GTA182 at RDEs doses in subjects with MTAPnull/lost advanced solid tumors; To evaluate the preliminary efficacy of GTA182 at RDEs doses in subjects with MTAPnull/lost advanced solid tumors, and to provide a basis for the recommended dose and indication selection for subsequent clinical trials. (3) Exploratory objectives: To explore biomarkers associated with the efficacy of GTA182.

Start Date30 Oct 2024

Sponsor / Collaborator

Shanghai Pailong Biotechnology Co., Ltd.

CTR20254181

/ Not yet recruitingPhase 1

评价GTA182联合伏美替尼在MTAP纯合型缺失的局部晚期或转移性非小细胞肺癌（NSCLC）受试者中的安全性、耐受性、药代动力学以及初步有效性的剂量递增和剂量扩展的I期临床研究

[Translation] A phase I clinical study evaluating the safety, tolerability, pharmacokinetics, and initial efficacy of GTA182 in combination with vortexinib in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) homozygous absence of MTAP.

Ia期（剂量递增阶段）主要目的：评估GTA182联合伏美替尼在MTAP纯合型缺失局部晚期或转移性NSCLC受试者中的安全性和耐受性，以确定扩展期推荐的联合剂量。次要目的：描述GTA182联合伏美替尼在MTAP纯合型缺失局部晚期或转移性NSCLC受试者中的药代动力学特征；评估GTA182联合伏美替尼在MTAP纯合型缺失局部晚期或转移性NSCLC受试者中的初步有效性。探索性目的：探索与GTA182疗效相关的生物标志物。 Ib期（剂量扩展阶段）主要目的：评估在Ia期推荐的联合剂量下GTA182联合伏美替尼在MTAP纯合型缺失局部晚期或转移性NSCLC受试者中的安全性和耐受性，以确认联合用药RP2D。次要目的：评估在Ia期推荐的联合剂量下GTA182联合伏美替尼在MTAP纯合型缺失局部晚期或转移性NSCLC受试者中的药代动力学特征；评估在Ia期推荐的联合剂量下GTA182联合伏美替尼在MTAP纯合型缺失局部晚期或转移性NSCLC受试者中的初步有效性，为后续临床试验推荐剂量选择提供依据。探索性目的：探索与GTA182疗效相关的生物标志物。

[Translation]

Phase Ia (Dose Escalation Phase) Primary Objective: To evaluate the safety and tolerability of GTA182 in combination with voreminib in patients with MTAP homozygous deletion locally advanced or metastatic NSCLC to determine the recommended combination dose for the extension phase. Secondary Objectives: To describe the pharmacokinetic characteristics of GTA182 in combination with voreminib in patients with MTAP homozygous deletion locally advanced or metastatic NSCLC; to assess the preliminary efficacy of GTA182 in combination with voreminib in patients with MTAP homozygous deletion locally advanced or metastatic NSCLC. Exploratory Objectives: To explore biomarkers related to the efficacy of GTA182. Phase Ib (Dose Extension Phase) Primary Objective: To evaluate the safety and tolerability of GTA182 in combination with voreminib at the Phase Ia recommended combination dose in patients with MTAP homozygous deletion locally advanced or metastatic NSCLC to confirm the RP2D of the combination therapy. Secondary objectives: To evaluate the pharmacokinetic characteristics of GTA182 in combination with vortexinib at the recommended combination dose in Phase Ia patients with MTAP homozygous deletion locally advanced or metastatic NSCLC; to assess the preliminary efficacy of GTA182 in combination with vortexinib at the recommended combination dose in Phase Ia patients with MTAP homozygous deletion locally advanced or metastatic NSCLC, providing a basis for dose selection in subsequent clinical trials. Exploratory objectives: To explore biomarkers associated with the efficacy of GTA182.

Start Date-

Sponsor / Collaborator

Shanghai Pailong Biotechnology Co., Ltd.

100 Clinical Results associated with GTA-182

100 Translational Medicine associated with GTA-182

100 Patents (Medical) associated with GTA-182

100 Deals associated with GTA-182

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Non-Small Cell Lung Cancer	Phase 1	China	Shanghai Pailong Biotechnology Co., Ltd.	30 Oct 2025
Methylthioadenosine phosphorylase deletion cancer	Phase 1	China	Shanghai Pailong Biotechnology Co., Ltd.	19 Nov 2024
Advanced Malignant Solid Neoplasm	Phase 1	China	Shanghai Pailong Biotechnology Co., Ltd.	30 Oct 2024
Locally Advanced Lung Non-Small Cell Carcinoma	IND Approval	China	Shanghai Pailong Biotechnology Co., Ltd.	29 Sep 2025
metastatic non-small cell lung cancer	IND Approval	China	Shanghai Pailong Biotechnology Co., Ltd.	29 Sep 2025

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