Evaluation of the Effect of Itraconazole on the Pharmacokinetics of HS-20093 in Patients With Advanced Solid Tumors

Hansoh Pharma

Status and phase

Enrolling

Phase 1

Conditions

Advanced Solid Tumors

Treatments

Drug: Itraconazole

Drug: HS-20093

Study type

Interventional

Funder types

Industry

Identifiers

NCT07186452

HS-20093-111

Details and patient eligibility

About

The primary objective of this study is to evaluate the effect of itraconazole on the pharmacokinetics of HS-20093 in patients with advanced solid tumors.

Full description

This is a multicenter, open-label, non-randomized, fixed-sequence, self-controlled clinical study designed to evaluate the effect of itraconazole on the pharmacokinetics of HS-20093 in patients with advanced solid tumors who have failed or are intolerant to standard therapy.

All participants will receive intravenous infusion of HS-20093 at a dose of 8 mg/kg every 3 weeks (Q3W), with each treatment cycle lasting 21 days. Participants will then take itraconazole capsules orally at 200 mg per dose during C2D17-C3D21

Enrollment

18 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Histologically or cytologically confirmed advanced solid tumors that have failed standard therapy or are intolerant to standard treatment.
According to RECIST 1.1 criteria, participants must have at least one target lesion.
ECOG performance status score of 0-1 with no deterioration within 2 weeks prior to the first dose.
Minimum expected survival greater than 12 weeks.

Exclusion criteria

Patients with a contraindication for receiving itraconazole according to the prescribing information
Patients with severe, uncontrolled, or active cardiovascular diseases