RecruitingPhase 2NCT07268040

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

A Multicenter, Open-label Phase II Clinical Study of SHR-7787 Combined With Other Antitumor Drugs in Patients With Advanced Solid Tumors


Sponsor

Shanghai Hengrui Pharmaceutical Co., Ltd.

Enrollment

400 participants

Start Date

Dec 23, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria6

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

Exclusion Criteria12

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

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Interventions

DRUGSHR-7787 Injection

SHR-7787 Injection.

DRUGSHR-1316 Injection

SHR-1316 Injection.

DRUGSHR-4849 Injection

SHR-4849 Injection.

DRUGEtoposide injection

Etoposide Injection.

DRUGCarboplatin injection

Carboplatin Injection.

DRUGCisplatin injection

Cisplatin Injection.

DRUGBP102 Injection

BP102 Injection.


Locations(2)

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

Wuhan, Hubei, China

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

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NCT07268040


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