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

NCT ID: NCT07268040

Last Updated: 2026-01-12

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

PHASE2

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-23

Study Completion Date

2028-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Malignant Solid Tumors

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-7787 combined with SHR-1316

SHR-7787 injection combined with SHR-1316 injection.

Group Type EXPERIMENTAL

SHR-7787 Injection

Intervention Type DRUG

SHR-7787 Injection.

SHR-1316 Injection

Intervention Type DRUG

SHR-1316 Injection.

SHR-7787 combined with SHR-4849

SHR-7787 injection combined with SHR-4849 injection.

Group Type EXPERIMENTAL

SHR-7787 Injection

Intervention Type DRUG

SHR-7787 Injection.

SHR-4849 Injection

Intervention Type DRUG

SHR-4849 Injection.

SHR-7787 combined with etoposide and carboplatin/cisplatin

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

Group Type EXPERIMENTAL

SHR-7787 Injection

Intervention Type DRUG

SHR-7787 Injection.

Etoposide injection

Intervention Type DRUG

Etoposide Injection.

Carboplatin injection

Intervention Type DRUG

Carboplatin Injection.

Cisplatin injection

Intervention Type DRUG

Cisplatin Injection.

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

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

Group Type EXPERIMENTAL

SHR-7787 Injection

Intervention Type DRUG

SHR-7787 Injection.

SHR-1316 Injection

Intervention Type DRUG

SHR-1316 Injection.

Etoposide injection

Intervention Type DRUG

Etoposide Injection.

Carboplatin injection

Intervention Type DRUG

Carboplatin Injection.

Cisplatin injection

Intervention Type DRUG

Cisplatin Injection.

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

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

Group Type EXPERIMENTAL

SHR-7787 Injection

Intervention Type DRUG

SHR-7787 Injection.

SHR-1316 Injection

Intervention Type DRUG

SHR-1316 Injection.

SHR-4849 Injection

Intervention Type DRUG

SHR-4849 Injection.

SHR-7787 combined with SHR-1316 and BP102

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

Group Type EXPERIMENTAL

SHR-7787 Injection

Intervention Type DRUG

SHR-7787 Injection.

SHR-1316 Injection

Intervention Type DRUG

SHR-1316 Injection.

BP102 Injection

Intervention Type DRUG

BP102 Injection.

SHR-7787 combined with SHR-4849 and BP102

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

Group Type EXPERIMENTAL

SHR-7787 Injection

Intervention Type DRUG

SHR-7787 Injection.

SHR-4849 Injection

Intervention Type DRUG

SHR-4849 Injection.

BP102 Injection

Intervention Type DRUG

BP102 Injection.

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

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

Group Type EXPERIMENTAL

SHR-7787 Injection

Intervention Type DRUG

SHR-7787 Injection.

SHR-1316 Injection

Intervention Type DRUG

SHR-1316 Injection.

SHR-4849 Injection

Intervention Type DRUG

SHR-4849 Injection.

Carboplatin injection

Intervention Type DRUG

Carboplatin Injection.

Cisplatin injection

Intervention Type DRUG

Cisplatin Injection.

Interventions

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SHR-7787 Injection

SHR-7787 Injection.

Intervention Type DRUG

SHR-1316 Injection

SHR-1316 Injection.

Intervention Type DRUG

SHR-4849 Injection

SHR-4849 Injection.

Intervention Type DRUG

Etoposide injection

Etoposide Injection.

Intervention Type DRUG

Carboplatin injection

Carboplatin Injection.

Intervention Type DRUG

Cisplatin injection

Cisplatin Injection.

Intervention Type DRUG

BP102 Injection

BP102 Injection.

Intervention Type DRUG

Eligibility Criteria

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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.
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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Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science & Technology

Wuhan, Hubei, China

Site Status RECRUITING

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xianhua Qiu

Role: CONTACT

+86-0518-82342973

Facility Contacts

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Qian Chu

Role: primary

+86-027-83663147

Shengxiang Ren

Role: primary

+86-021-65115006 ext. 3051

Other Identifiers

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SHR-7787-201

Identifier Type: -

Identifier Source: org_study_id

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