A Trial of SHR-A1921 for Injection in Subjects With Advanced Solid Tumors
About the study
The study is being conducted to evaluate the Safety, Tolerability, Pharmacokinetics, and Clinical Activity of SHR-1921.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion Criteria:
- Able and willing to provide a written informed consent
- Subjects consented and willing to provide required tumor tissue of sufficient quantity and of adequate tumor tissue content
- Male or female
- Subjects with clinically or pathologically confirmed advanced (recurrent, unresectable or metastatic) solid tumors who have failed prior standard of care therapy
- ECOG performance status of 0-1
EXCLUSION CRITERIA
Exclusion Criteria:
- Has uncontrolled clinically symptomatic pleural effusion, pericardial effusion, carcinomatous ascites
- Has untreated brain metastasis, or with concomitant meningeal metastasis or spinal cord compression
- Has known history of other documented malignancy
- Has known history of acquired immunodeficiency syndrome (AIDS)
- Has significant cardiovascular disease that is not well controlled, such as: (1) New York Heart Association (NYHA) Grade ≥ 2 cardiac failure
- Has active or prior documented interstitial pneumonia/interstitial lung disease
- Has experienced Grade ≥ 2 hemorrhage events within 4 weeks prior to the first dose
- Has known active hepatitis B
- Has known allergies to SHR-1921 component
- Has other potential factors that may interfere with the study results, or result in the premature discontinuation as determined by the investigator.
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study Details
Contition
Advanced Solid Tumor
Age (in years)
18+
Phase
PHASE1
Participants Needed
9
Est. Completion Date
Apr 24, 2024
Treatment Type
INTERVENTIONAL
Sponsor
Atridia Pty Ltd.
ClinicalTrials.gov NCT Identifier
NCT05594875
Study Number
SHR-A1921-I-102-AUS
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