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

NCT ID: NCT07229586

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-02

Study Completion Date

2027-12-31

Brief Summary

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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).

Detailed Description

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Conditions

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Solid Tumor

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SHR-7367 + SHR-1316 Group

SHR-7367 combined with SHR-1316.

Group Type EXPERIMENTAL

SHR-7367 Injection

Intervention Type DRUG

SHR-7367 injection.

SHR-1316 Injection

Intervention Type DRUG

SHR-1316 injection.

SHR-7367 + SHR-1316 + AG Group

SHR-7367 combined with SHR-1316 and AG.

Group Type EXPERIMENTAL

SHR-7367 Injection

Intervention Type DRUG

SHR-7367 injection.

SHR-1316 Injection

Intervention Type DRUG

SHR-1316 injection.

Paclitaxel for Injection

Intervention Type DRUG

Paclitaxel for injection (Albumin Bound).

Gemcitabine Hydrochloride for Injection

Intervention Type DRUG

Gemcitabine Hydrochloride for injection.

SHR-7367 + AG Group

SHR-7367 combined with AG.

Group Type EXPERIMENTAL

SHR-7367 Injection

Intervention Type DRUG

SHR-7367 injection.

Paclitaxel for Injection

Intervention Type DRUG

Paclitaxel for injection (Albumin Bound).

Gemcitabine Hydrochloride for Injection

Intervention Type DRUG

Gemcitabine Hydrochloride for injection.

Interventions

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SHR-7367 Injection

SHR-7367 injection.

Intervention Type DRUG

SHR-1316 Injection

SHR-1316 injection.

Intervention Type DRUG

Paclitaxel for Injection

Paclitaxel for injection (Albumin Bound).

Intervention Type DRUG

Gemcitabine Hydrochloride for Injection

Gemcitabine Hydrochloride for injection.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Hengrui Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Botao Zhu

Role: CONTACT

Phone: +86-0518-82342973

Email: [email protected]

Facility Contacts

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Jihui Hao

Role: primary

Other Identifiers

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HRS-4642-205-01

Identifier Type: -

Identifier Source: org_study_id