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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

107 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-01

Study Completion Date

2025-12-01

Brief Summary

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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

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Detailed Description

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Conditions

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Advanced Solid Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

SHR-A1904 monotherapy

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SHR-A1904

Group Type EXPERIMENTAL

SHR-A1904

Intervention Type DRUG

SHR-A1904

Interventions

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SHR-A1904

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No