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

Shanghai Hengrui Pharmaceutical Co., Ltd.1 site in 1 country22 target enrollmentMarch 6, 2023

ConditionsAdvanced Solid Tumors

InterventionsSHR-7367

DrugsSHR-7367

Overview

Phase: Phase 1
Intervention: SHR-7367
Conditions: Advanced Solid Tumors
Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.
Enrollment: 22
Locations: 1
Primary Endpoint: Dose-limiting toxicities (DLTs)
Status: Active, Not Recruiting
Last Updated: 9 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

March 6, 2023

End Date

November 30, 2025

Last Updated

9 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Shanghai Hengrui Pharmaceutical Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Arms & Interventions

SHR-7367

Intervention: SHR-7367

Outcomes

Primary Outcomes

Dose-limiting toxicities (DLTs)

Time Frame: Up to 3 weeks

Number of participants with DLTs

Recommended phase II dose

Time Frame: first dose of study medication up to 21 days

The Recommended phase II dose of SHR-7367 injection

Incidence and severity of adverse events (AEs)/serious adverse events (SAEs)

Time Frame: Up to 12 months

• Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0

Secondary Outcomes

steady-state valley concentration (Ctrough, ss)(Up to 12 months)
peak time (Tmax)(Up to 12 months)
peak concentration (Cmax)(Up to 12 months)
steady-state peak concentration (Cmax, ss)(Up to 12 months)
Tumor response using RECIST 1.1(From first dose to disease progression or death, whichever comes first, 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)
clearance rate (CL)(Up to 12 months)
steady-state apparent volume of distribution (Vss)(Up to 12 months)
accumulation ratio (Rac)(Up to 12 months)
Immunogenicity index: drug-resistant antibody (ADA)(Up to 12 months)
Efficacy endpoints: Objective response rate (ORR)(Up to 12 months)
elimination half-life (t1/2)(Up to 12 months)
percentage of activated B lymphocyte subsets in peripheral blood(Up to 12 months)