Target- |
MechanismBacteria replacements |
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Inactive Indication- |
Drug Highest PhasePhase 2 |
First Approval Ctry. / Loc.- |
First Approval Date- |
Target- |
Mechanism- |
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Inactive Indication- |
Drug Highest PhasePreclinical |
First Approval Ctry. / Loc.- |
First Approval Date- |
一项在晚期实体瘤患者中评估基因改造的减毒沙门氏菌SGN1瘤内注射给药的安全性和耐受性的I/IIa期、开放性、剂量递增和剂量扩展研究
[Translation] A Phase I/IIa, open-label, dose escalation and dose expansion study to evaluate the safety and tolerability of intratumoral injection of genetically modified attenuated Salmonella SGN1 in patients with advanced solid tumors
第1部分
主要目的:
评估SGN1瘤内注射在晚期实体瘤患者中的安全性和耐受性。
次要目的:
1、初步确定最大耐受剂量(MTD)和最佳生物剂量(OBD)。
2、分析并描述SGN1的PK特征。
3、评估SGN1的细菌脱落。
4、评估SGN1瘤内注射在晚期实体瘤患者中的初步疗效。
5、评估其他安全性指标。
探索性目的:
Choi标准评估的肿瘤治疗疗效。 第2部分:
主要目的:
评估SGN1在特定肿瘤亚型中的初步疗效。
次要目的:
1、评估SGN1在特定肿瘤亚型中的安全性。
2、分析和描述SGN1的PK特征。
3、评估SGN1的细菌脱落。
4、评估其他安全性指标。
探索性目的:
1、根据肿瘤类型探索相应的肿瘤生物标志物。
2、Choi标准评估的肿瘤治疗疗效。
[Translation] part 1
main purpose:
To evaluate the safety and tolerability of intratumoral injection of SGN1 in patients with advanced solid tumors.
Secondary purpose:
1. Preliminarily determine the maximum tolerated dose (MTD) and optimal biological dose (OBD).
2. Analyze and describe the PK characteristics of SGN1.
3. Assess the bacterial shedding of SGN1.
4. Evaluate the preliminary efficacy of SGN1 intratumoral injection in patients with advanced solid tumors.
5. Evaluate other safety indicators.
Exploratory purpose:
Tumor treatment efficacy assessed by Choi criteria. part 2:
main purpose:
To assess the preliminary efficacy of SGN1 in specific tumor subtypes.
Secondary purpose:
1. Evaluate the safety of SGN1 in specific tumor subtypes.
2. Analyze and describe the PK characteristics of SGN1.
3. Assess the bacterial shedding of SGN1.
4. Evaluate other safety indicators.
Exploratory purpose:
1. Explore corresponding tumor biomarkers according to tumor types.
2. Tumor treatment efficacy evaluated by Choi criteria.
一项在晚期实体瘤患者中评估基因改造的减毒沙门氏菌SGN1的安全性、耐受性和初步疗效的I/IIa期、开放性研究
[Translation] A Phase I/IIa, open-label study to evaluate the safety, tolerability and preliminary efficacy of genetically modified attenuated Salmonella SGN1 in patients with advanced solid tumors
第1部分和第2部分 剂量递增阶段:
主要目的:
评估SGN1在晚期实体瘤患者中的安全性和耐受性。
次要目的:
1、初步确定最大耐受剂量(MTD)和最佳生物剂量(OBD)。
2、分析并描述SGN1的PK特征。
3、评估SGN1的细菌脱落。
4、评估SGN1的ADA。
5、评估SGN1在晚期实体瘤患者治疗中的抗肿瘤作用。
6、评估其他安全性指标。
探索性目的:
根据Choi标准评估疗效。 第3部分 剂量扩展阶段
主要目的:
评估SGN1在特定肿瘤亚型中的抗肿瘤作用。
次要目的:
1、评估SGN1在特定肿瘤亚型中的安全性。
2、分析并描述SGN1的PK特征。
3、评估SGN1的ADA。
4、评估其他安全性指标。
探索性目的:
根据Choi标准评估疗效。
[Translation] Part 1 and Part 2 Dose Escalation Phase:
main purpose:
To evaluate the safety and tolerability of SGN1 in patients with advanced solid tumors.
Secondary purpose:
1. Preliminarily determine the maximum tolerated dose (MTD) and optimal biological dose (OBD).
2. Analyze and describe the PK characteristics of SGN1.
3. Assess the bacterial shedding of SGN1.
4. Evaluate the ADA of SGN1.
5. Evaluate the anti-tumor effect of SGN1 in the treatment of patients with advanced solid tumors.
6. Evaluate other safety indicators.
Exploratory purpose:
Efficacy was evaluated according to Choi criteria. Part 3 Dose Expansion Phase
main purpose:
Assess the anti-tumor effects of SGN1 in specific tumor subtypes.
Secondary purpose:
1. Evaluate the safety of SGN1 in specific tumor subtypes.
2. Analyze and describe the PK characteristics of SGN1.
3. Evaluate the ADA of SGN1.
4. Evaluate other safety indicators.
Exploratory purpose:
Efficacy was evaluated according to Choi criteria.
A Phase I/IIa, Open-label, Dose Escalation and Dose-Expansion Study to Evaluate the Safety and Tolerability of Modified Salmonella Typhimurium SGN1 Administered Via Intratumoral Injection in Patients With Advanced Solid Tumors
Objectives: To characterize safety, tolerability, MTD and OBD of intratumoral injection of SGN1 in patients with advanced solid tumors, and to preliminarily investigate the efficacy and safety of SGN1 in specific tumor subtypes at OBD doses.
Study Rationale: The mechanism of action for SGN1 is based on the fact that most tumors are methionine dependent. SGN1 is designed to be used as a tumor therapeutic bacterium that can preferentially replicate and accumulate in tumors and starve them of essential amino acids by delivering the oncolytic enzyme L-Methioninase.
Patient Population: Patients presenting with histologically confirmed advanced and/or metastatic solid tumors that are refractory to standard therapy and for which no other conventional therapy exists.
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