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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-23

Study Completion Date

2026-08-31

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Advanced Solid Tumors

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HS-20093 + Itraconazole

Group Type EXPERIMENTAL

HS-20093

Intervention Type DRUG

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.

Itraconazole

Intervention Type DRUG

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

Interventions

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HS-20093

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.

Intervention Type DRUG

Itraconazole

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No