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A Trial of SHR-4849 in Advanced Solid Tumors

A Trial of SHR-4849 in Advanced Solid Tumors

Recruiting
18-75 years
All
Phase 1

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Overview

The study is being conducted to evaluate the safety, tolerability and efficacy of SHR-4849 injection in Advanced Solid Tumors. To explore the reasonable dosage of SHR-4849 for Advanced Solid Tumors.

Eligibility

Inclusion Criteria:

  1. Subject has provided informed consent prior to initiation of any study-procedures
  2. Age from 18 to 75 years old at the time of signing the informed consent
  3. Histologically or cytologically confirmed advanced solid tumors
  4. At least one measurable lesion was identified per RECIST 1.1
  5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
  6. Has a life expectancy of at least 3 months.
  7. Adequate organ function
  8. Subjects of both genders of child-bearing potential were required to use highly effective contraception from the time they provided written informed consent until 6 months after the last dose of the trial drug

Exclusion Criteria:

  1. Subjects with active central nervous system (CNS) metastasis.
  2. Subjects with a history of malignant tumors within 5 years prior to the first dose
  3. Subjects with uncontrolled cancer pain.
  4. Subjects with severe cardiovascular disease.
  5. Subjects with clinically significant hemorrhage
  6. Subjects with uncontrolled pleural effusion, peritoneal effusion and pericardial effusion
  7. Subjects highly suspected of interstitial lung disease
  8. Subjects with serious infection within 4 weeks prior to the first dose
  9. Known history of human immunodeficiency virus (HIV),active hepatitis B virus or hepatitis C virus infection.
  10. The adverse events of previous antineoplastic therapy did not recover to NCI-CTCAE≤ grade 1
  11. Subjects who received anti-cancer treatment within 4 weeks prior to the first dose
  12. Subjects who received major surgery within 4 weeks prior to the first dose
  13. Subjects who plan to receive or have received live vaccines within 28 days prior to the first dose.
  14. Female subjects who were pregnant, lactating, or planned to become pregnant during the study period
  15. Known allergic to any component of SHR-4849 products
  16. 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.
  17. Based on the investigator's judgment, subjects with other conditions that may affect study results, interfere with study procedures,

Study details
    Advanced Solid Tumors

NCT06443489

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

1 September 2025

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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