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Patients will receive escalating doses of ASN004 to identify the best dose for further study.

ASN004 is an antibody-drug conjugate for the treatment of advanced or metastatic solid tumors.

ASN004

Alison L Hannah, MD

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 of ASN004 in Patients With Advanced Solid Tumors

An Open Label, Multicenter, Dose-Finding Clinical Phase 1 Study of ASN004 to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy in Patients With Advanced Malignant Solid Tumors

Number of patients with 5T4 expression that have a complete response, partial response or prolonged stable disease when receiving ASN004.

The MTD will be determined by evaluating the number of subjects with treatment related adverse events (AEs) and DLTs.

Calculate the amount of ASN004 in the bloodstream

Calculate the maximum amount of ASN004 in the bloodstream

Calculate how fast ASN004 leaves the body

Change from baseline in the sum of the longest dimension in millimeters or each measurable lesion

Number of subjects that have resolution on non-measurable tumor lesions

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study of ASN004 in Patients With Advanced Solid Tumors	NCT04410224	Solid Tumor	ASN004	18 Years -	Kirilys Therapeutics Inc.
Study of ASN004 in Patients With Advanced Solid Tumors	NCT04410224	Solid Tumor	ASN004	18 Years -	Kirilys Therapeutics Inc.

Spots Global Cancer Trial Database for general solid tumors