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

Advanced Solid Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05740202
• Other study ID #: SHR-7367-I-101
• Status: Recruiting
• Phase: Phase 1
• Start date: March 6, 2023
• Est. completion date: November 30, 2025

Study information

• Verified date: January 2023
• Source: Shanghai Hengrui Pharmaceutical Co., Ltd.
• Contact: Junshuang diao
• Phone: +0518-82342973
• Email: junshuang.diao[@]hrglobe.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 182
• Est. completion date: November 30, 2025
• Est. primary completion date: November 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Solid Tumors
• Neoplasms

Intervention

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.

Locations

Country	Name	City	State
China	Tianjin Medical University Cancer Institute and Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Hengrui Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose-limiting toxicities (DLTs)	Number of participants with DLTs	Up to 3 weeks
Primary	Recommended phase II dose	The Recommended phase II dose of SHR-7367 injection	first dose of study medication up to 21 days
Primary	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	Tumor response using RECIST 1.1		From first dose to disease progression or death, whichever comes first, up to 12 months
Secondary	peak time (Tmax)		Up to 12 months
Secondary	peak concentration (Cmax)		Up to 12 months
Secondary	area under curve from 0 to the last measurable concentration time point t (AUC0-t),		Up to 12 months
Secondary	area under curve from 0 to infinity (AUC0-8)		Up to 12 months
Secondary	elimination half-life (t1/2)		Up to 12 months
Secondary	clearance rate (CL)		Up to 12 months
Secondary	steady-state apparent volume of distribution (Vss)		Up to 12 months
Secondary	steady-state peak concentration (Cmax, ss)		Up to 12 months
Secondary	steady-state valley concentration (Ctrough, ss)		Up to 12 months
Secondary	accumulation ratio (Rac)		Up to 12 months
Secondary	percentage of activated B lymphocyte subsets in peripheral blood		Up to 12 months
Secondary	Immunogenicity index: drug-resistant antibody (ADA)		Up to 12 months
Secondary	Efficacy endpoints: Objective response rate (ORR)		Up to 12 months