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Recruiting NCT07028281

A Trial of SHR-4849 Combined With Other Antitumor 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-4849、SHR-1316、SHR-8068、BP102、carboplatin、cisplatin.
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-4849 Injection Combined With Other Antineoplastic Drugs in Patients With Malignant Solid Tumors

Overview

The study is being conducted to evaluate the safety, tolerability and efficacy of SHR-4849 injection combined with other antitumor drugs in patients with malignant solid tumors.

Interventions

  • Drug SHR-4849、SHR-1316、SHR-8068、BP102、carboplatin、cisplatin
    SHR-4849、SHR-1316、SHR-8068、BP102、carboplatin、cisplatin

Primary outcome measures

  • DLT：the incidence of events associated with the investigational drug determined by the investigator during the observation period(The first stage) [Time frame: up to 21 days]
  • Incidence and severity of AE/SAE：According to NCI-CTCAE v5.0 evaluation criteria, from the signing of informed consent to the end of safety follow-up(The first stage) [Time frame: up to 24 months]
  • Objective Response Rate (ORR) as Assessed by investigators(The second stage) [Time frame: up to 24 months]
Secondary outcome measures (10)
  • ORR(The first stage) [Time frame: up to 24 months]
  • DoR(The first stage) [Time frame: up to 24 months]
  • DCR(The first stage) [Time frame: up to 24 months]
  • PFS(The first stage) [Time frame: up to 24 months]
  • OS(The first stage) [Time frame: up to 30 months]
  • DoR(The second stage) [Time frame: up to 24 months]
  • DCR(The second stage) [Time frame: up to 24 months]
  • PFS(The second stage) [Time frame: up to 24 months]
  • OS(The second stage) [Time frame: up to 30 months]
  • Incidence and severity of AE/SAE：According to NCI-CTCAE v5.0 evaluation criteria, from the signing of informed consent to the end of safety follow-up(The second stage) [Time frame: up to 24 months]

Eligibility criteria

Inclusion criteria

  • Subject has provided informed consent prior to initiation of any study-procedures
  • Age from 18 to 75 years old at the time of signing the informed consent
  • Histologically or cytologically confirmed solid tumors
  • At least one measurable lesion was identified per RECIST 1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
  • Has a life expectancy of at least 3 months.
  • Adequate organ function
  • Subjects of both genders of child-bearing potential were required to use highly effective contraception from the time they provided written informed consent until 8 months after the last dose of the trial drug

Exclusion criteria

  • Subjects with active central nervous system (CNS) metastasis.
  • Subjects with a history of malignant tumors within 5 years prior to the first dose
  • Subjects with uncontrolled cancer pain.
  • Subjects with severe cardiovascular disease.
  • Subjects with clinically significant hemorrhage
  • Subjects with uncontrolled pleural effusion, peritoneal effusion and pericardial effusion
  • Subjects highly suspected of interstitial lung disease
  • Subjects with serious infection within 4 weeks prior to the first dose
  • Known history of human immunodeficiency virus (HIV)，active hepatitis B virus or hepatitis C virus infection.
  • The adverse events of previous antineoplastic therapy did not recover to NCI-CTCAE≤ grade 1
  • Subjects who received anti-cancer treatment within 4 weeks prior to the first dose
  • Subjects who received major surgery within 4 weeks prior to the first dose
  • Subjects who plan to receive or have received live vaccines within 28 days prior to the first dose.
  • Female subjects who were pregnant, lactating, or planned to become pregnant during the study period
  • Known allergic to any component of investigational drugs
  • Alcohol abuse, drug abuse, other serious medical conditions (including mental illness) requiring combined treatment, and other conditions that may affect subject safety or data collection.
  • Based on the investigator's judgment, subjects with other conditions that may affect study results, interfere with study procedures,

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

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Affiliated Cancer Hospital of Shandong First Medical University — Jinan

Identifiers

NCT: NCT07028281 · SHR-4849-201

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗