Study of ASN004 in Patients With Advanced Solid Tumors
- Registration Number
- NCT04410224
- Lead Sponsor
- Kirilys Therapeutics Inc.
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 19
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description ASN004 ascending doses ASN004 Patients will receive escalating doses of ASN004 to identify the best dose for further study.
- Primary Outcome Measures
Name Time Method Determine the maximum tolerated dose of ASN004 first 21 days for patients administered ASN004 every 3 weeks, and first 28 days for patients administered ASN004 every 4 weeks The MTD will be determined by evaluating the number of subjects with treatment related adverse events (AEs) and DLTs.
- Secondary Outcome Measures
Name Time Method Calculate the maximum plasma concentration at steady state First 63 days Calculate the maximum amount of ASN004 in the bloodstream
Calculate the pharmacokinetic (PK) area under the plasma concentration of ASN004 First 63 days Calculate the amount of ASN004 in the bloodstream
Change in the status of non-measurable tumor lesions Up to 1 year Number of subjects that have resolution on non-measurable tumor lesions
Calculate the terminal elimination rate of ASN004 First 63 days Calculate how fast ASN004 leaves the body
Change in the size of measurable tumor lesions up to 1 year Change from baseline in the sum of the longest dimension in millimeters or each measurable lesion
Appearance of new tumor lesions Up to 1 year Number of subjects with new lesions
Trial Locations
- Locations (3)
Next Oncology
🇺🇸Fairfax, Virginia, United States
Winship Cancer Institute of Emory University
🇺🇸Atlanta, Georgia, United States
NEXT Oncology
🇺🇸San Antonio, Texas, United States