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

December 18, 2025 updated by: Shanghai Hengrui Pharmaceutical Co., Ltd.

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300060
        • Recruiting
        • Tianjin Medical University Cancer Institute and Hospital
        • Principal Investigator:
          • Jihui Hao
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. 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.
  2. 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.
  3. 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).
  4. Surgery or chemotherapy within 4 weeks of the first dose of study treatment.
  5. Active HBV/HCV/HIV infection.
  6. Untreated and/or uncontrolled brain metastases.
  7. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: SHR-7367 + SHR-1316 Group
SHR-7367 combined with SHR-1316.
Drug: SHR-1316 Injection
SHR-1316 injection.
Drug: SHR-7367 Injection
SHR-7367 injection.
Experimental: SHR-7367 + SHR-1316 + AG Group
SHR-7367 combined with SHR-1316 and AG.
Drug: SHR-1316 Injection
SHR-1316 injection.
Drug: Gemcitabine Hydrochloride for Injection
Gemcitabine Hydrochloride for injection.
Drug: SHR-7367 Injection
SHR-7367 injection.
Drug: Paclitaxel for Injection
Paclitaxel for injection (Albumin Bound).
Experimental: SHR-7367 + AG Group
SHR-7367 combined with AG.
Drug: Gemcitabine Hydrochloride for Injection
Gemcitabine Hydrochloride for injection.
Drug: SHR-7367 Injection
SHR-7367 injection.
Drug: Paclitaxel for Injection
Paclitaxel for injection (Albumin Bound).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Stage 1 (IB Period): Dose-limiting toxicity (DLT).
Time Frame: Up to 28 days.
Up to 28 days.
Stage 1 (IB Period): Adverse events (AEs).
Time Frame: About 1 year.
About 1 year.
Stage 1 (IB Period): Serious adverse events (SAEs).
Time Frame: About 1 year.
About 1 year.
Phase II: Investigator-assessed objective response rate (ORR).
Time Frame: Assessed every 6 weeks, about 1 year.
Assessed every 6 weeks, about 1 year.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Assessed every 6 weeks, about 1 year.
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.
Assessed every 6 weeks, about 1 year.
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.
Assessed every 6 weeks, about 1 year.
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.
Assessed every 6 weeks, about 1 year.
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.
Assessed approximately once every 1 month, about 1 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai Hengrui Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 2, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 13, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 13, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 17, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 19, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 18, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HRS-4642-205-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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