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NCT Number: NCT07268040

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

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.

Recruiting

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science & Technology, Wuhan, Hubei, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

SHR-7787 Injection

Drug

SHR-7787 Injection.

SHR-1316 Injection

Drug

SHR-1316 Injection.

SHR-4849 Injection

Drug

SHR-4849 Injection.

Etoposide injection

Drug

Etoposide Injection.

Carboplatin injection

Drug

Carboplatin Injection.

Cisplatin injection

Drug

Cisplatin Injection.

BP102 Injection

Drug

BP102 Injection.

Primary outcomes

  1. The Recommended phase II dose of SHR-7787 injection monotherapy (stage I)

    Time frame: Expected to be two years after the start of the study.

  2. Incidence and severity of adverse events (AEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 (stage I)

    Time frame: About 1 year after study initiation.

  3. Incidence and severity of serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 (stage I)

    Time frame: About 1 year after study initiation.

  4. Incidence of Dose Limited Toxicity (DLT) described in the protocol (stage I)

    Time frame: About 1 year after study initiation.

  5. Objective response rate (ORR) (stage II)

    Time frame: Expected to be two years after the start of the study.

  6. Progress Free Survival (FPS) (stage II)

    Time frame: Expected to be two years after the start of the study.

Secondary outcomes

  1. Objective response rate (ORR)

    Time frame: About 1 year.

  2. Duration of Response (DoR)

    Time frame: About 1 year.

  3. Disease Control Rate (DCR)

    Time frame: About 1 year.

  4. Progress Free Survival (PFS)

    Time frame: About 1 year.

  5. Overall Survival (OS)

    Time frame: About 1 year.

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Shanghai Hengrui Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Dec 5, 2025
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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