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A Study of SHR-A1904 in Patients With Advanced Solid Cancer | Clinical Trials | Clareo Health

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

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

NCT04877717•Shanghai Hengrui Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

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

Exclusion Criteria

•1. Plan to receive any other anti-tumor treatments during the study treatment period of this study
•2. Received other clinical investigational products or treatments within 4 weeks before the first dose of the study
•3. Received anti-tumor therapies such as chemotherapy, radiotherapy, biological therapy, targeted therapy, or immunotherapy within 4 weeks before the first dose of the study
•4. Underwent a major surgery other than diagnosis or biopsy within 4 weeks before the first dose of the study
•5. Subjects with known brain metastases
•6. 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
•7. 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

Locations (1)

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, China

Key Dates

Start Date

July 1, 2021

Primary Completion Date

December 1, 2025

Completion Date

December 1, 2025

Last Updated

March 25, 2025

Enrollment

107

ACTUAL participants

Conditions

Advanced Solid Cancer

Interventions

SHR-A1904

DRUG

A Clinical Trial to Test if the Investigational Drug BNT329 is Safe and Potentially Beneficial for People With Advanced Solid Tumors Known to Express the Tumor Marker CA19-9

NCT07186842

Advanced Solid Cancers

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RECRUITINGPHASE1

Study of SYN818 for the Treatment of Advanced or Metastatic Solid Tumors

NCT06666270

Advanced Solid CancerMetastatic Solid Tumor+5 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 25, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Clinical Trial to Test if the Investigational Drug BNT329 is Safe and Potentially Beneficial for People With Advanced Solid Tumors Known to Express the Tumor Marker CA19-9

Study of SYN818 for the Treatment of Advanced or Metastatic Solid Tumors

An Investigational Immunotherapy Study of BMS-986301 Alone or in Combination With Nivolumab, and Ipilimumab in Participants With Advanced Solid Cancers

A Study of BMS-863233 in Patients With Advanced and/or Metastatic Solid Tumors

Study ADI-PEG 20 Plus Pembrolizumab in Advanced Solid Cancers