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NCT Number: NCT07028281

A Trial of SHR-4849 Combined With Other Antitumor Drugs in Patients With Malignant Solid Tumors

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Affiliated Cancer Hospital of Shandong First Medical University

Jinan, Shandong, 250117, China

Location status: Recruiting

Location contact

Jinming Yu

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

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

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,

Treatment and study plan

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

Drug

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

Primary outcomes

  1. 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

  2. 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

  3. Objective Response Rate (ORR) as Assessed by investigators(The second stage)

    Time frame: up to 24 months

Secondary outcomes

  1. ORR(The first stage)

    Time frame: up to 24 months

    Objective Response Rate (ORR) as Assessed by investigators. The proportion of subjects whose best response was PR or CR according to RECIST1.1

  2. DoR(The first stage)

    Time frame: up to 24 months

    Duration of Response (DOR) as Assessed by investigators according to RECIST1.1, Defined as the period of time from the first documented tumor response to the first documented objective progression or death of any cause.

  3. DCR(The first stage)

    Time frame: up to 24 months

    Disease Control Rate(DCR) as Assessed by investigators. the proportion of subjects whose best response was PR or CR or SD according to RECIST1.1

  4. PFS(The first stage)

    Time frame: up to 24 months

    Progression-free Survival (PFS) as Assessed by investigators according to RECIST1.1. Defined as the time from the initiation of the first medication to tumor progression or death from any cause (whichever comes first)

  5. OS(The first stage)

    Time frame: up to 30 months

    Overall Survival . Defined as the time from the initiation of the first medication to death from any cause.

  6. DoR(The second stage)

    Time frame: up to 24 months

    Duration of Response (DOR) as Assessed by investigators according to RECIST1.1, Defined as the period of time from the first documented tumor response to the first documented objective progression or death of any cause.

  7. DCR(The second stage)

    Time frame: up to 24 months

    Disease Control Rate(DCR) as Assessed by investigators. the proportion of subjects whose best response was PR or CR or SD according to RECIST1.1

  8. PFS(The second stage)

    Time frame: up to 24 months

    Progression-free Survival (PFS) as Assessed by investigators according to RECIST1.1. Defined as the time from the initiation of the first medication to tumor progression or death from any cause (whichever comes first)

  9. OS(The second stage)

    Time frame: up to 30 months

    Overall Survival . Defined as the time from the initiation of the first medication to death from any cause.

  10. 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

Study contacts

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

Sponsors and collaborators

Lead sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Industry

Registry information

Official study title

A Multicenter, Open-label, Phase II Clinical Study of SHR-4849 Injection Combined With Other Antineoplastic Drugs in Patients With Malignant Solid Tumors

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jun 19, 2025
Registry last updated
Mar 3, 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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