This study aims to evaluate the safety and preliminary efficacy of SHR-7367 in combination with antineoplastic agents in subjects with advanced solid tumors, and to determine the maximum tolerated dose (MTD) and the recommended Phase II dose (RP2D).

Start Date01 Nov 2025

Sponsor / Collaborator

Shanghai Hengrui Pharmaceutical Co., Ltd.

NCT05740202

/ Active, not recruitingPhase 1

A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacodynamics and Efficacy of SHR-7367 in Subjects With Advanced Solid Tumors

This is a dose-escalation and dose-expansion Phase 1 trial to evaluate the safety and tolerability of SHR-7367 in subjects with advanced solid tumors.

Start Date06 Mar 2023

Sponsor / Collaborator

Shanghai Hengrui Pharmaceutical Co., Ltd.

CTR20254469

/ Not yet recruitingPhase 1/2

SHR-7367联合抗肿瘤药物在实体瘤受试者中的安全性、耐受性及有效性的IB/II期临床研究

[Translation] A Phase IB/II clinical study of the safety, tolerability, and efficacy of SHR-7367 in combination with antitumor drugs in subjects with solid tumors.

第一阶段(IB期)主要研究目的：评估SHR-7367联合其他抗肿瘤药物在实体瘤受试者中的安全性、耐受性；确定II期联合用药最大耐受剂量（MTD）及II期推荐剂量（RP2D）。第一阶段(IB期)次要研究目的：评估SHR-7367联合其他抗肿瘤药物在实体瘤受试者中的初步疗效；评价受试者中SHR-7367的药代动力学（PK）特征及免疫原性。第二阶段(II期)主要研究目的：评估SHR-7367联合抗肿瘤药物在实体瘤受试者中的客观缓解率（ORR）。第二阶段(II期)次要研究目的：评估SHR-7367联合其他抗肿瘤药物在受试者的安全性和其他有效性终点；评价受试者中SHR-7367的药代动力学（PK）特征及免疫原性。

[Translation]

The primary objective of the Phase IB study was to evaluate the safety and tolerability of SHR-7367 in combination with other antitumor drugs in patients with solid tumors; and to determine the maximum tolerated dose (MTD) and the recommended dose (RP2D) for Phase II combination therapy. The secondary objectives of the Phase IB study were to evaluate the preliminary efficacy of SHR-7367 in combination with other antitumor drugs in patients with solid tumors; and to assess the pharmacokinetic (PK) characteristics and immunogenicity of SHR-7367 in patients. The primary objective of the Phase II study was to evaluate the objective response rate (ORR) of SHR-7367 in combination with other antitumor drugs in patients with solid tumors. The secondary objectives of the Phase II study were to evaluate the safety and other efficacy endpoints of SHR-7367 in combination with other antitumor drugs in patients; and to assess the pharmacokinetic (PK) characteristics and immunogenicity of SHR-7367 in patients.

Start Date-

Sponsor / Collaborator

Shanghai Hengrui Pharmaceutical Co., Ltd.

100 Clinical Results associated with SHR-7367

100 Translational Medicine associated with SHR-7367

100 Patents (Medical) associated with SHR-7367

100 Deals associated with SHR-7367

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Solid tumor	Phase 2	China	Shanghai Hengrui Pharmaceutical Co., Ltd.	01 Nov 2025
Advanced cancer	Phase 1	China	Shanghai Hengrui Pharmaceutical Co., Ltd.	06 Mar 2023
Advanced Malignant Solid Neoplasm	Phase 1	China	Shanghai Hengrui Pharmaceutical Co., Ltd.	06 Mar 2023
KRAS G12D mutation Solid Tumors	IND Approval	China	Shanghai Hengrui Pharmaceutical Co., Ltd.	21 Oct 2025

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