A Phase 1/2 Open-label, First-in-human, Dose Escalation and Expansion Study for the Evaluation of Safety, Pharmacokinetics, Pharmacodynamics, and Anti-tumor Activity of SAR444200-based Regimen in Participants With Advanced Solid Tumors.

This is Phase 1/Phase 2, open label, multiple cohort, first-in-human study to evaluate safety, PK, PDy and efficacy of SAR444200 as a monotherapy or in combination with other anti-cancer agents for participants aged at least 18 years with previously treated metastatic malignancies.

Start Date20 Sep 2022

Sponsor / Collaborator

Sanofi

CTR20233146 / Not yet recruitingPhase 1

一项在晚期实体瘤患者中评估 SAR444200 给药方案的安全性、药代动力学、药效动力学和抗肿瘤活性的Ⅰ/Ⅱ期、开放性、首次人体、剂量递增和扩展研究。

[Translation] A Phase I/II, open-label, first-in-human, dose-escalation and expansion study evaluating the safety, pharmacokinetics, pharmacodynamics, and antitumor activity of a dosing regimen of SAR444200 in patients with advanced solid tumors.

主要目的第1A部分单药治疗和第1B部分联合治疗剂量递增：在接受SAR444200单药治疗和与阿替利珠单抗联合治疗的磷脂酰肌醇-3阳性（GPC3+）实体瘤患者中，确定SAR444200的最大耐受剂量（MTD）/最大给药剂量（MAD）、推荐的Ⅱ期研究剂量（RP2D）（包括导入剂量）和安全性特征; 第 2A 部分单药治疗扩展：在GPC3+非小细胞肺癌（NSCLC）受试者中评估SAR444200单药在RP2D下的初步临床活性次要目的第1A部分单药治疗和第1B部分联合治疗剂量递增：在GPC3＋实体瘤受试者中评估SAR444200单药治疗和与阿替利珠单抗联合治疗时在RP2D下的初步临床活性; 第 1A、2A 和 1B 部分：表征SAR444200单药治疗时的药代动力学（PK）特征，并评估SAR444200与阿替利珠单抗联合治疗时的PK特征; 第 1A、2A 和 1B 部分：评估SAR444200和阿替利珠单抗的潜在免疫原性; 第 2A 部分单药治疗扩展：评估次要疗效参数; 第 2A 部分单药治疗剂量扩展：确定 SAR444200 的安全性特性

[Translation]

Primary Objectives Part 1A Monotherapy and Part 1B Combination Therapy Dose Escalation: Determine the maximum tolerated dose (MTD)/maximum administered dose (MAD), recommended Phase II study dose (RP2D) (including lead-in dose), and safety profile of SAR444200 in patients with phosphatidylinositol-3-positive (GPC3+) solid tumors receiving SAR444200 monotherapy and combination therapy with atezolizumab; Part 2A Monotherapy Extension: Evaluate the preliminary clinical activity of SAR444200 monotherapy at RP2D in GPC3+ non-small cell lung cancer (NSCLC) subjects Secondary Objectives Part 1A Monotherapy and Part 1B Combination Therapy Dose Escalation: Evaluate the preliminary clinical activity of SAR444200 monotherapy and combination therapy with atezolizumab at RP2D in subjects with GPC3+ solid tumors; Parts 1A, 2A and 1B Part 1: Characterize the pharmacokinetic (PK) profile of SAR444200 as monotherapy and evaluate the PK profile of SAR444200 in combination with atezolizumab; Parts 1A, 2A, and 1B: Evaluate the potential immunogenicity of SAR444200 and atezolizumab; Part 2A Monotherapy Expansion: Evaluate secondary efficacy parameters; Part 2A Monotherapy Dose Expansion: Determine the safety profile of SAR444200

Start Date-

Sponsor / Collaborator

Sanofi-Aventis Recherche et Développement SA

[+1]

100 Clinical Results associated with SAR444200

100 Translational Medicine associated with SAR444200

100 Patents (Medical) associated with SAR444200

100 Deals associated with SAR444200

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Advanced Malignant Solid Neoplasm	Phase 2	US	Sanofi	20 Sep 2022
Advanced Malignant Solid Neoplasm	Phase 2	CN	Sanofi	20 Sep 2022
Advanced Malignant Solid Neoplasm	Phase 2	CA	Sanofi	20 Sep 2022
Advanced Malignant Solid Neoplasm	Phase 2	SG	Sanofi	20 Sep 2022
Advanced Malignant Solid Neoplasm	Phase 2	KR	Sanofi	20 Sep 2022
GPC3 Positive Neoplasms	IND Approval	CN	Sanofi (China) Investment Co. Ltd.	09 Jul 2023
GPC3 Positive Neoplasms	IND Approval	CN	Sanofi-Aventis Recherche et Développement SA	09 Jul 2023

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05450562 (Phase 1/2 open-label study of the anti-GPC3 T-cell engager SAR444200, ASCO2024)	Phase 1/2	Advanced Malignant Solid Neoplasm interleukin-6 \| interferon gamma \| alpha-fatal protein (AFP)	24	SAR444200 3 mg	beulcludqb(gpoqustgkc) = 2 events with hospitalization prolongation for a Grade 1 and 2 cytokine release syndrome [CRS] that recovered completely without and with Tocilizumab, respectively, 1 event with pneumonitis Grade 3 emgwsvzzmv (ujmsyjfbhj ) View more	Positive	24 May 2024
				SAR444200 1 mg

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Leverages most recent intelligence information, enabling fullest potential.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis

SAR444200

Overview

Basic Info

Related

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Regulation