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

NCT05740202 | Active Not Recruiting Phase 1

• 1 other identifier: SHR-7367-I-101
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (14)

• 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

Study Arms (1)

SHR-7367

EXPERIMENTAL

Drug: SHR-7367

Interventions

SHR-7367 DRUG

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.

SHR-7367

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Hengrui Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300060, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 28, 2023
• First Posted: February 22, 2023
• Study Start: March 6, 2023
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: August 5, 2025

Record last verified: 2025-07

Locations

CN (1)