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Active, Not Recruiting

NCT Number: NCT04877717

A Study of SHR-A1904 in Patients With Advanced Solid Cancer

The study is being conducted to assess the safety and tolerability of SHR-A1904 in patients with advanced solid cancer and to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD), and recommended phase II dose (RP2D) of SHR-A1904

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Advanced Solid Cancer

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study
  • Males or females aged 18-75 years old
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
  • Has a life expectancy≥ 3 months
  • Has at least one measurable lesion as defined by RECIST v1.1
  • Pathologically confirmed advanced solid cancer

Exclusion criteria

  • Plan to receive any other anti-tumor treatments during the study treatment period of this study
  • Received other clinical investigational products or treatments within 4 weeks before the first dose of the study
  • Received anti-tumor therapies such as chemotherapy, radiotherapy, biological therapy, targeted therapy, or immunotherapy within 4 weeks before the first dose of the study
  • Underwent a major surgery other than diagnosis or biopsy within 4 weeks before the first dose of the study
  • Subjects with known brain metastases
  • Grade II-IV cardiac insufficiency as per the New York Heart Association (NYHA) criteria; arrhythmia requiring long-term drug control; unstable angina or acute myocardial infarction within 6 months before the first dose of the study
  • presence of accompanying diseases (such as poorly controlled hypertension, serious diabetes mellitus, thyroid disorder, psychosis, etc.) that may pose serious risks to the safety of the subject or may affect the subject's ability to complete the study, or any other situation as judged by the investigator

Treatment and study plan

SHR-A1904

Drug

SHR-A1904

Primary outcomes

  1. Determine the Maximum Tolerated Dose of SHR-A1904

    Time frame: up to 1 year

Secondary outcomes

  1. Maximum concentration (Cmax)

    Time frame: up to 1 year

  2. Time to maximum concentration (Tmax)

    Time frame: up to 1 year

  3. Area under the drug concentration-time curve from time 0 to the last measurable concentration time point (AUC0-t)

    Time frame: up to 1 year

  4. Anti-drug antibody (ADA) of SHR-A1904

    Time frame: up to 1 year

  5. Objective response rate (ORR)

    Time frame: up to 1 year

Sponsors and collaborators

Lead sponsor

Shanghai Hengrui Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

An Open-Label, Single-Arm, Multi-Center Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SHR-A1904 in Patients With Advanced Solid Tumors

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
May 7, 2021
Registry last updated
Mar 25, 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.

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