A Trial of SHR-7367 in Subjects With Advanced Solid Tumors

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Advanced Solid Tumors
• Intervention / Treatment: Drug: SHR-7367

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China, 300060
      • Tianjin Medical University Cancer Institute and Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Ability to understand and voluntarily agrees to participate by giving written informed consent for the study;
2. Male or female aged ≥18 years and ≤75 years at the time of signing the ICF;
3. Histopathologically or cytologically documented advanced or metastatic malignancies;
4. At least 1 measurable lesion conforming to RECIST 1.1 criteria;
5. An Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1;
6. Female and male patients of reproductive potential must agree to use highly effective contraception.

Exclusion Criteria:

1. Any immunostimulants administered within 4 weeks;
2. Systemic anti-tumor therapy within 4 weeks;
3. Any investigational cancer therapy administered within 4 weeks;
4. Surgical procedures requiring general anesthesia within 4 weeks;
5. History of autoimmune diseases;
6. History of immunodeficiency;
7. Severe infections within 2 weeks prior to the first study treatment;
8. Clinically significant cardiovascular condition;
9. Prior malignancy (other than current malignant tumor) within 5 ears before the first dose of study treatment;
10. Known history of serious allergic reactions to the investigational product or its main ingredients.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SHR-7367	Drug: SHR-7367; The study was divided into three phases, the dose escalation phase and the dose extension phase and therapeutic effect extension of SHR-7367 in subjects with advanced malignant tumors.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dose-limiting toxicities (DLTs)	Number of participants with DLTs	Up to 3 weeks
Recommended phase II dose	The Recommended phase II dose of SHR-7367 injection	first dose of study medication up to 21 days
Incidence and severity of adverse events (AEs)/serious adverse events (SAEs)	• Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0	Up to 12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Tumor response using RECIST 1.1	From first dose to disease progression or death, whichever comes first, up to 12 months
peak time (Tmax)	Up to 12 months
peak concentration (Cmax)	Up to 12 months
area under curve from 0 to the last measurable concentration time point t (AUC0-t),	Up to 12 months
area under curve from 0 to infinity (AUC0-∞)	Up to 12 months
elimination half-life (t1/2)	Up to 12 months
clearance rate (CL)	Up to 12 months
steady-state apparent volume of distribution (Vss)	Up to 12 months
steady-state peak concentration (Cmax, ss)	Up to 12 months
steady-state valley concentration (Ctrough, ss)	Up to 12 months
accumulation ratio (Rac)	Up to 12 months
percentage of activated B lymphocyte subsets in peripheral blood	Up to 12 months
Immunogenicity index: drug-resistant antibody (ADA)	Up to 12 months
Efficacy endpoints: Objective response rate (ORR)	Up to 12 months

Collaborators and Investigators

• Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2023
• Primary Completion (Estimated): November 30, 2025
• Study Completion (Estimated): November 30, 2025

Study Registration Dates

• First Submitted: January 28, 2023
• First Submitted That Met QC Criteria: February 13, 2023
• First Posted (Actual): February 22, 2023

Study Record Updates

• Last Update Posted (Actual): August 5, 2025
• Last Update Submitted That Met QC Criteria: July 31, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: SHR-7367-I-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No