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

NCT04877717 | Active Not Recruiting Phase 1

• 1 other identifier: SHR-A1904-I-101
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Advanced Solid Cancer

Outcome Measures

Primary Outcomes (1)

• Determine the Maximum Tolerated Dose of SHR-A1904

  up to 1 year

Secondary Outcomes (5)

• Maximum concentration (Cmax)

  up to 1 year

• Time to maximum concentration (Tmax)

  up to 1 year

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

  up to 1 year

• Anti-drug antibody (ADA) of SHR-A1904

  up to 1 year

• Objective response rate (ORR)

  up to 1 year

Study Arms (1)

SHR-A1904

EXPERIMENTAL

Drug: SHR-A1904

Interventions

SHR-A1904 DRUG

SHR-A1904

SHR-A1904

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Hengrui Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Related Publications (1)

• Ruan DY, Wu HX, Luo SX, Huang WW, Liang XJ, Niu ZX, Dang Q, Li HL, Pan ZY, Lu HX, Zhang YQ, Li XY, Xiao XY, Cai SR, Dong YG, Zhang J, Li Z, Lan HT, Wang X, Zhou Y, Liu L, Liu HL, Xu PS, Suo AL, Jia RN, Li YQ, Peng XD, Wang SC, Yu AA, Xie J, Qiu MZ, Xu RH. The antibody-drug conjugate SHR-A1904 for targeting CLDN18.2 in advanced gastric or gastroesophageal junction cancer: a phase 1 trial. Nat Med. 2025 Sep;31(9):3037-3046. doi: 10.1038/s41591-025-03781-w. Epub 2025 Jul 16.

  PMID: 40670772 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: SHR-A1904 monotherapy

Study Record Dates

• First Submitted: April 27, 2021
• First Posted: May 7, 2021
• Study Start: July 1, 2021
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 25, 2025

Record last verified: 2025-03

Locations

CN (1)