Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06443489

A Trial of SHR-4849 in Advanced Solid Tumors

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Advanced Solid Tumors

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Jilin Cancer Hospital

Jilin City, Changchun, China

Location status: Recruiting

Location contact

Ying cheng

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 advanced 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 6 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 SHR-4849 products
  • 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

Drug

SHR-4849

Primary outcomes

  1. DLT：the incidence of events associated with the investigational drug determined by the investigator during the observation period

    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；

    Time frame: up to 24 months

  3. MTD or MAD：after all subjects of dose escalation phase be enrolled，and all subjects complete at least one cycle of dosing observation.

    Time frame: up to 24 months

  4. RP2D：after all subjects of dose escalation and dose expansion phase be enrolled，and all subjects complete at least one cycle of dosing observation.

    Time frame: up to 24 months

Secondary outcomes

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

    Time frame: up to 24 months

  2. DCR：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

    Time frame: up to 24 months

  3. DoR: 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.

    Time frame: up to 24 months

  4. PFS: 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)；

    Time frame: up to 24 months

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

    Time frame: up to 30 months

Study contacts

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

wei Hou

CONTACT

[email protected]

+86 18036618327

Sponsors and collaborators

Lead sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Industry

Registry information

Official study title

A Phase I ,Open-label, Multicenter Clinical Study to Evaluate the Safety, Tolerability , Pharmacokinetics and Efficacy of SHR-4849 in Patients With Advanced Solid Tumors

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 5, 2024
Registry last updated
Mar 5, 2025

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.