A Trial of SHR-4849 in Advanced Solid Tumors

Last updated: February 28, 2025
Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Overall Status: Active - Recruiting

Phase

1

Condition

Neoplasms

Treatment

SHR-4849

Clinical Study ID

NCT06443489
SHR-4849-101
  • Ages 18-75
  • All Genders

Study Summary

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 Criteria

Inclusion

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 highlyeffective contraception from the time they provided written informed consent until 6months after the last dose of the trial drug

Exclusion

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 pericardialeffusion

  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 orhepatitis 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 tothe first dose.

  14. Female subjects who were pregnant, lactating, or planned to become pregnant duringthe study period

  15. Known allergic to any component of SHR-4849 products

  16. Alcohol abuse, drug abuse, other serious medical conditions (including mentalillness) requiring combined treatment, and other conditions that may affect subjectsafety or data collection.

  17. Based on the investigator's judgment, subjects with other conditions that may affectstudy results, interfere with study procedures,

Study Design

Total Participants: 80
Treatment Group(s): 1
Primary Treatment: SHR-4849
Phase: 1
Study Start date:
June 26, 2024
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • Jilin Cancer Hospital

    Jilin, Changchun
    China

    Active - Recruiting

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