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

Hengrui Medicine

Status and phase: Active, not recruiting; Phase 1

Conditions: Advanced Solid Cancer

Treatments: Drug: SHR-A1904

Study type: Interventional

Funder types: Industry

Identifiers

NCT04877717

SHR-A1904-I-101

Details and patient eligibility

About

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

Enrollment: 107 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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107 participants in 1 patient group

SHR-A1904

Experimental group

Treatment:

Drug: SHR-A1904