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

Hengrui Medicine

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Solid Tumor

Treatments: Drug: SHR-7367 Injection; Drug: Gemcitabine Hydrochloride for Injection; Drug: Paclitaxel for Injection; Drug: SHR-1316 Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT07229586

HRS-4642-205-01

Details and patient eligibility

About

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).

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 3 patient groups

SHR-7367 + SHR-1316 Group

Experimental group

Description:

SHR-7367 combined with SHR-1316.

Treatment:

Drug: SHR-1316 Injection

Drug: SHR-7367 Injection

SHR-7367 + SHR-1316 + AG Group

Experimental group

Description:

SHR-7367 combined with SHR-1316 and AG.

Treatment:

Drug: Gemcitabine Hydrochloride for Injection

Drug: Paclitaxel for Injection

Drug: SHR-1316 Injection

Drug: SHR-7367 Injection

SHR-7367 + AG Group

Experimental group

Description:

SHR-7367 combined with AG.

Treatment:

Drug: Gemcitabine Hydrochloride for Injection

Drug: Paclitaxel for Injection

Drug: SHR-7367 Injection