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Recruiting NCT07268040

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

Phase II Interventional Malignant Solid Tumors

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SHR-7787 Injection, SHR-1316 Injection, SHR-4849 Injection, Etoposide injection.
Who it may be relevant to
Registry conditions: Malignant Solid Tumors. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug SHR-7787 Injection
    SHR-7787 Injection.
  • Drug SHR-1316 Injection
    SHR-1316 Injection.
  • Drug SHR-4849 Injection
    SHR-4849 Injection.
  • Drug Etoposide injection
    Etoposide Injection.
  • Drug Carboplatin injection
    Carboplatin Injection.
  • Drug Cisplatin injection
    Cisplatin Injection.
  • Drug BP102 Injection
    BP102 Injection.

Primary outcome measures

  • 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.]
  • 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.]
  • 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.]
  • Incidence of Dose Limited Toxicity (DLT) described in the protocol (stage I) [Time frame: About 1 year after study initiation.]
  • Objective response rate (ORR) (stage II) [Time frame: Expected to be two years after the start of the study.]
  • Progress Free Survival (FPS) (stage II) [Time frame: Expected to be two years after the start of the study.]
Secondary outcome measures (5)
  • Objective response rate (ORR) [Time frame: About 1 year.]
  • Duration of Response (DoR) [Time frame: About 1 year.]
  • Disease Control Rate (DCR) [Time frame: About 1 year.]
  • Progress Free Survival (PFS) [Time frame: About 1 year.]
  • Overall Survival (OS) [Time frame: About 1 year.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 2 centers
  • Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science & T — Wuhan
  • Shanghai Pulmonary Hospital — Shanghai

Identifiers

NCT: NCT07268040 · SHR-7787-201

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗