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Clinical Trial Summary

Participants in this study will receive ASN004 once every 3 or 4 weeks by intravenous infusion. The ASN004 dosing schedule may be modified based on emerging data and Safety Review Committee decision. The study will test various doses of ASN004 to find out the highest safe dose to test in future trials. Eligible subjects will be sequentially enrolled in cohorts at escalated doses.


Clinical Trial Description

Eligible patients will be sequentially enrolled at escalating doses. Dose escalation decisions will be based on the review of clinical safety and pharmacokinetic (PD) and pharmacodynamics (PD) data and agreed upon by the Sponsor and investigators. The maximum tolerated dose (MTD) will have an estimated DLT rate of < 33%. Cohorts may be expanded at any dose level or at the MTD for further evaluation of safety, or PK parameters as required. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04410224
Study type Interventional
Source Kirilys Therapeutics Inc.
Contact
Status Active, not recruiting
Phase Phase 1
Start date April 8, 2022
Completion date September 30, 2024

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