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Completed

NCT Number: NCT05740202

A Trial 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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300060, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Dose-limiting toxicities (DLTs)

    Time frame: Up to 3 weeks

    Number of participants with DLTs

  2. Recommended phase II dose

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

    The Recommended phase II dose of SHR-7367 injection

  3. 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

  1. Tumor response using RECIST 1.1

    Time frame: From first dose to disease progression or death, whichever comes first, up to 12 months

  2. peak time (Tmax)

    Time frame: Up to 12 months

  3. peak concentration (Cmax)

    Time frame: Up to 12 months

  4. area under curve from 0 to the last measurable concentration time point t (AUC0-t),

    Time frame: Up to 12 months

  5. area under curve from 0 to infinity (AUC0-∞)

    Time frame: Up to 12 months

  6. elimination half-life (t1/2)

    Time frame: Up to 12 months

  7. clearance rate (CL)

    Time frame: Up to 12 months

  8. steady-state apparent volume of distribution (Vss)

    Time frame: Up to 12 months

  9. steady-state peak concentration (Cmax, ss)

    Time frame: Up to 12 months

  10. steady-state valley concentration (Ctrough, ss)

    Time frame: Up to 12 months

  11. accumulation ratio (Rac)

    Time frame: Up to 12 months

  12. percentage of activated B lymphocyte subsets in peripheral blood

    Time frame: Up to 12 months

  13. Immunogenicity index: drug-resistant antibody (ADA)

    Time frame: Up to 12 months

  14. Efficacy endpoints: Objective response rate (ORR)

    Time frame: Up to 12 months

Sponsors and collaborators

Lead sponsor

Shanghai Hengrui Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 22, 2023
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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