A Trial of SHR-A1921 for Injection in Subjects With Advanced Solid Tumors

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About the study

The study is being conducted to evaluate the Safety, Tolerability, Pharmacokinetics, and Clinical Activity of SHR-1921.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION 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

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.

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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.
Phone iconCall : +61 02 9299 043Email iconEmail Study Center

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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