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

Phase 1

Recruiting

• Conditions: Advanced Solid Tumors
• Interventions: Drug: SHR-7367

• Registration Number: NCT05740202
• Lead Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-01
• Study First Submitted: 2023-01-28
• Study First Submitted QC: 2023-02-13
• Study First Posted: 2023-02-22
• Study Start: 2023-03-06
• Last Update Submitted: 2023-05-10
• Last Update Posted: 2023-05-12
• Primary Completion: 2025-11-30
• Study Completion: 2025-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 182

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SHR-7367	SHR-7367	-

Primary Outcome Measures

Name	Time	Method
Dose-limiting toxicities (DLTs)	Up to 3 weeks	Number of participants with DLTs
Recommended phase II dose	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)	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 Outcome Measures

Name	Time	Method
area under curve from 0 to the last measurable concentration time point t (AUC0-t),	Up to 12 months
steady-state peak concentration (Cmax, ss)	Up to 12 months
steady-state valley concentration (Ctrough, ss)	Up to 12 months
peak time (Tmax)	Up to 12 months
peak concentration (Cmax)	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 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

Trial Locations

Locations (1)

Tianjin Medical University Cancer Institute and Hospital; 🇨🇳 Tianjin, Tianjin, China