A Trial of SHR-7787 Injection Combined With Other Anti-tumor Drugs in Patients With Malignant Solid Tumors

Hengrui Medicine

Status and phase: Enrolling; Phase 2

Conditions: Malignant Solid Tumors

Treatments: Drug: Etoposide injection; Drug: BP102 Injection; Drug: SHR-4849 Injection; Drug: Carboplatin injection; Drug: SHR-1316 Injection; Drug: SHR-7787 Injection; Drug: Cisplatin injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT07268040

SHR-7787-201

Details and patient eligibility

About

This study aims to evaluate the safety, tolerability and efficacy of SHR-7787 in combination with other anti-tumor drugs in patients with malignant solid tumors.

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Ability to understand and voluntarily agrees to participate by giving written informed consent for the study;
2. Patients with histologically or cytologically confirmed unresectable solid tumors;
3. At least one measurable lesion was identified per RECIST 1.1;
4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1;
5. Adequate organ functions as defined per protocol;
6. Minimum life expectancy of 3 months.

Exclusion criteria

1. Patients with known active central nervous system (CNS) metastases;
2. History of other malignancy within the past 5 years, with exceptions defined in the protocol;
3. Patients with uncontrolled cancer pain;
4. Patients with serious cardiovascular and/or cerebrovascular diseases;
5. Uncontrollable third-space effusion, such as pleural effusion, pericardial effusion or peritoneal effusion;
6. Patients with Severe infections within 4 weeks prior to the first dose;
7. Active pulmonary tuberculosis infection;
8. History of immunodeficiency;
9. History of autoimmune diseases;
10. The adverse events of previous antineoplastic therapy did not recover to CTCAE≤ grade 1;
11. Pregnant or nursing women, or planned to become pregnant during the study period;
12. Known allergic to any component of investigational drugs.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 8 patient groups

SHR-7787 combined with SHR-1316

Experimental group

Description:

SHR-7787 injection combined with SHR-1316 injection.

Treatment:

Drug: SHR-7787 Injection

Drug: SHR-1316 Injection

SHR-7787 combined with SHR-4849

Experimental group

Description:

SHR-7787 injection combined with SHR-4849 injection.

Treatment:

Drug: SHR-7787 Injection

Drug: SHR-4849 Injection

SHR-7787 combined with etoposide and carboplatin/cisplatin

Experimental group

Description:

SHR-7787 injection combined with etoposide and carboplatin/cisplatin injection.

Treatment:

Drug: Cisplatin injection

Drug: SHR-7787 Injection

Drug: Carboplatin injection

Drug: Etoposide injection

SHR-7787 combined with SHR-1316, etoposide, carboplatin/cisplatin

Experimental group

Description:

SHR-7787 injection combined with SHR-1316, etoposide, carboplatin/cisplatin injection.

Treatment:

Drug: Cisplatin injection

Drug: SHR-7787 Injection

Drug: Carboplatin injection

Drug: SHR-1316 Injection

Drug: Etoposide injection

SHR-7787 combined with SHR-4849 and SHR-1316

Experimental group

Description:

SHR-7787 injection combined with SHR-4849 and SHR-1316 injection.

Treatment:

Drug: SHR-7787 Injection

Drug: SHR-1316 Injection

Drug: SHR-4849 Injection

SHR-7787 combined with SHR-1316 and BP102

Experimental group

Description:

SHR-7787 injection combined with SHR-1316 and BP102 injection.

Treatment:

Drug: SHR-7787 Injection

Drug: SHR-1316 Injection

Drug: BP102 Injection

SHR-7787 combined with SHR-4849 and BP102

Experimental group

Description:

SHR-7787 injection combined with SHR-4849 and BP102 injection.

Treatment:

Drug: SHR-7787 Injection

Drug: SHR-4849 Injection

Drug: BP102 Injection

SHR-7787 combined with SHR-4849, SHR-1316 and carboplatin/cisplatin

Experimental group

Description:

SHR-7787 injection combined with SHR-4849, SHR-1316 and carboplatin/cisplatin injection.

Treatment:

Drug: Cisplatin injection

Drug: SHR-7787 Injection

Drug: Carboplatin injection

Drug: SHR-1316 Injection

Drug: SHR-4849 Injection