Spots Global Cancer Trial Database for Study of ASN004 in Patients With Advanced Solid Tumors

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Trial Identification

Brief Title: Study of ASN004 in Patients With Advanced Solid Tumors

Official Title: 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

Study ID: NCT04410224

Conditions

Solid Tumor

Interventions

ASN004

Study Description

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.