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

Phase 1RecruitingNCT07186452

Hansoh BioMedical R&D Company18 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Advanced Solid Tumors

Interventions

HS-20093DRUG

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.

ItraconazoleDRUG

Participants will then take itraconazole capsules orally at 200 mg per dose during C2D17-C3D21

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Histologically or cytologically confirmed advanced solid tumors that have failed standard therapy or are intolerant to standard treatment. 2. According to RECIST 1.1 criteria, participants must have at least one target lesion. 3. ECOG performance status score of 0-1 with no deterioration within 2 weeks prior to the first dose. 4. Minimum expected survival greater than 12 weeks. Exclusion Criteria: 1. Patients with a contraindication for receiving itraconazole according to the prescribing information 2. Patients with severe, uncontrolled, or active cardiovascular diseases

Locations (1)

Hunan Cancer Hospital

Changsha, Hunan, China

RECRUITING