Clinical trial
An Open-Label, Multi-Center Phase I Clinical Study on the Safety, Tolerability, Pharmacokinetics, and Clinical Activity of SHR-A1921 for Injection in Subjects With Advanced Solid Tumors
Name
SHR-A1921-I-102-AUS
Description
The study is being conducted to evaluate the Safety, Tolerability, Pharmacokinetics, and Clinical Activity of SHR-1921.
Trial arms
Trial start
2022-12-01
Estimated PCD
2023-10-31
Trial end
2024-07-31
Status
Active (not recruiting)
Phase
Early phase I
Treatment
SHR-1921
Subject will receive a single dose of SHR-1921 at dose level 1/2/3 on Day of each cycles
Arms:
SHR-1921
Size
9
Primary endpoint
Number of subjects with adverse events (AEs)
Screening up to study completion, an average of 1 year
Number of subjects with laboratory tests findings of potential clinical importance
Screening up to study completion, an average of 1 year
Incidence of vital sign abnormalities e.g. Systolic and Diastolic BP, Pulse rate.
Screening up to study completion, an average of 1 year
Measure ECG
Screening up to study completion, an average of 1 year
Eligibility criteria
Inclusion Criteria:
1. Able and willing to provide a written informed consent
2. Subjects consented and willing to provide required tumor tissue of sufficient quantity and of adequate tumor tissue content
3. Male or female
4. Subjects with clinically or pathologically confirmed advanced (recurrent, unresectable or metastatic) solid tumors who have failed prior standard of care therapy
5. ECOG performance status of 0-1
Exclusion Criteria:
1. Has uncontrolled clinically symptomatic pleural effusion, pericardial effusion, carcinomatous ascites
2. Has untreated brain metastasis, or with concomitant meningeal metastasis or spinal cord compression
3. Has known history of other documented malignancy
4. Has known history of acquired immunodeficiency syndrome (AIDS)
5. Has significant cardiovascular disease that is not well controlled, such as: (1) New York Heart Association (NYHA) Grade ≥ 2 cardiac failure
6. Has active or prior documented interstitial pneumonia/interstitial lung disease
7. Has experienced Grade ≥ 2 hemorrhage events within 4 weeks prior to the first dose
8. Has known active hepatitis B
9. Has known allergies to SHR-1921 component
10. Has other potential factors that may interfere with the study results, or result in the premature discontinuation as determined by the investigator.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'SHR-1921 single arm study in pt. with Advance solid tumors', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 9, 'type': 'ACTUAL'}}
Updated at
2023-12-28
1 organization
1 product
1 indication
Organization
AtridiaProduct
SHR-1921Indication
Advanced Solid Tumor