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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
19
ASN004 is an antibody-drug conjugate for the treatment of advanced or metastatic solid tumors.
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States
NEXT Oncology
Austin, Texas, United States
NEXT Oncology
San Antonio, Texas, United States
Next Oncology
Fairfax, Virginia, United States
Determine the maximum tolerated dose of ASN004
The MTD will be determined by evaluating the number of subjects with treatment related adverse events (AEs) and DLTs.
Time frame: first 21 days for patients administered ASN004 every 3 weeks, and first 28 days for patients administered ASN004 every 4 weeks
Calculate the pharmacokinetic (PK) area under the plasma concentration of ASN004
Calculate the amount of ASN004 in the bloodstream
Time frame: First 63 days
Calculate the maximum plasma concentration at steady state
Calculate the maximum amount of ASN004 in the bloodstream
Time frame: First 63 days
Calculate the terminal elimination rate of ASN004
Calculate how fast ASN004 leaves the body
Time frame: First 63 days
Change in the size of measurable tumor lesions
Change from baseline in the sum of the longest dimension in millimeters or each measurable lesion
Time frame: up to 1 year
Change in the status of non-measurable tumor lesions
Number of subjects that have resolution on non-measurable tumor lesions
Time frame: Up to 1 year
Appearance of new tumor lesions
Number of subjects with new lesions
Time frame: Up to 1 year
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