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

Advanced Solid Cancer Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04877717
• Other study ID #: SHR-A1904-I-101
• Status: Recruiting
• Phase: Phase 1
• Start date: July 1, 2021
• Est. completion date: January 1, 2024

Study information

• Verified date: April 2021
• Source: Shanghai Hengrui Pharmaceutical Co., Ltd.
• Contact: Chunlei Jin, Ph.D.
• Phone: +86-021-23511999
• Email: chunlei.jin[@]hengrui.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 94
• Est. completion date: January 1, 2024
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Advanced Solid Cancer

Intervention

Drug:
• SHR-A1904
SHR-A1904

Locations

Country	Name	City	State
China	Sun Yat-Sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Hengrui Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the Maximum Tolerated Dose of SHR-A1904		up to 1 year
Secondary	Maximum concentration (Cmax)		up to 1 year
Secondary	Time to maximum concentration (Tmax)		up to 1 year
Secondary	Area under the drug concentration-time curve from time 0 to the last measurable concentration time point (AUC0-t)		up to 1 year
Secondary	Anti-drug antibody (ADA) of SHR-A1904		up to 1 year
Secondary	Objective response rate (ORR)		up to 1 year