Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07229586

A Study of SHR-7367 With Anti-tumor Agents in Patients With Solid Tumors

This study aims to evaluate the safety and preliminary efficacy of SHR-7367 in combination with antineoplastic agents in subjects with advanced solid tumors, and to determine the maximum tolerated dose (MTD) and the recommended Phase II dose (RP2D).

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300060, China

Location status: Recruiting

Location contact

Jihui Hao

CONTACT

[email protected]

+86-022-23340123

Jihui Hao

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Be able and willing to provide a written informed consent.
  • Age 18-75 years old (inclusive) at the time of signing the informed consent form.
  • ECOG performance status 0-1.
  • Life expectancy is not less than 12 weeks.
  • At least one measurable lesion per RECIST v1.1.
  • Adequate organ and marrow function as defined by the protocol.

Exclusion criteria

  • Presence of uncontrollable psychiatric illness and other conditions such as known alcoholism, drug or substance abuse, criminal detention, etc., that affect the completion of the study procedures.
  • Known hypersensitivity to any component of SHR-7367; History of severe allergic reactions to other monoclonal antibodies/fusion protein drugs; Known history of severe hypersensitivity to antineoplastic agents in combination.
  • Subjects who are participating in other clinical studies or whose first dose is less than 4 weeks from the end of the previous clinical study (last dose).
  • Surgery or chemotherapy within 4 weeks of the first dose of study treatment.
  • Active HBV/HCV/HIV infection.
  • Untreated and/or uncontrolled brain metastases.
  • Any other condition that, in the judgment of the investigator, may increase the risk of participating in the study, interfere with the results of the study, or be unsuitable for participation in this study.

Treatment and study plan

SHR-7367 Injection

Drug

SHR-7367 injection.

SHR-1316 Injection

Drug

SHR-1316 injection.

Paclitaxel for Injection

Drug

Paclitaxel for injection (Albumin Bound).

Gemcitabine Hydrochloride for Injection

Drug

Gemcitabine Hydrochloride for injection.

Primary outcomes

  1. Stage 1 (IB Period): Dose-limiting toxicity (DLT).

    Time frame: Up to 28 days.

  2. Stage 1 (IB Period): Adverse events (AEs).

    Time frame: About 1 year.

  3. Stage 1 (IB Period): Serious adverse events (SAEs).

    Time frame: About 1 year.

  4. Phase II: Investigator-assessed objective response rate (ORR).

    Time frame: Assessed every 6 weeks, about 1 year.

Secondary outcomes

  1. Investigator-assessed objective response rate (ORR).

    Time frame: Assessed every 6 weeks, about 1 year.

    Complete response + Partial response (CR+PR) based on RECIST v1.1.

  2. Disease control rate (DCR).

    Time frame: Assessed every 6 weeks, about 1 year.

    Complete response + Partial response + Stable disease (CR+PR+SD) based on RECIST v1.1.

  3. Duration of response (DoR).

    Time frame: Assessed every 6 weeks, about 1 year.

    Time from documentation of tumor response to disease progression assessed among patients who had an objective response.

  4. Progression Free Survival (PFS).

    Time frame: Assessed every 6 weeks, about 1 year.

    Time from C1D1 to the first assessment of disease progression or death, whichever is earlier.

  5. Incidence and severity of Adverse events (AEs).

    Time frame: Assessed approximately once every 1 month, about 1 year.

    Time from C1D1 to the first assessment of disease progression or death, whichever is earlier.

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Shanghai Hengrui Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Phase IB/II Clinical Study of the Safety, Tolerability and Efficacy of SHR-7367 in Combination With Anti-tumor Agents in Subjects With Solid Tumors

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Nov 17, 2025
Registry last updated
Dec 19, 2025

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.

Published trials that share one or more normalized conditions with this study.