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NCT Number: NCT07186452

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

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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Key information

Conditions

Advanced Solid Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HS-20093

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

Drug

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

Primary outcomes

  1. Cmax of HS-20093 and free toxin

    Time frame: Three treatment cycles, each cycle lasting for three weeks.

    Maximum concentration of HS-20093 and free toxin, measured by appropriate analytical methods.

  2. AUC0-16d of HS-20093 and free toxin

    Time frame: Three treatment cycles, each cycle lasting for three weeks.

    Area under the concentration-time curve from time zero to 16 days of HS-20093 and free free toxin, calculated by non-compartmental analysis.

Secondary outcomes

  1. Tmax of HS-20093 and free toxin

    Time frame: Three treatment cycles, each cycle lasting for three weeks.

    Time to reach maximum concentration of HS-20093 and free toxin, derived directly from observed concentration-time data.

  2. t1/2 of HS-20093 and free toxin

    Time frame: Three treatment cycles, each cycle lasting for three weeks.

    Terminal elimination half-life of HS-20093 and free toxin.

  3. AUC0-∞ and AUC0-tau of HS-20093 and free toxin

    Time frame: Three treatment cycles, each cycle lasting for three weeks.

    Area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞) and during the dosing interval (AUC0-tau) of HS-20093 and free toxin.

  4. Cmin of HS-20093 and free toxin

    Time frame: Three treatment cycles, each cycle lasting for three weeks.

    Minimum observed concentration of HS-20093 and free toxin.

  5. CL of HS-20093 and free toxin

    Time frame: Three treatment cycles, each cycle lasting for three weeks.

    Clearance of HS-20093 and free toxin.

  6. V of HS-20093 and free toxin

    Time frame: Three treatment cycles, each cycle lasting for three weeks.

    Volume of distribution of HS-20093 and free toxin.

  7. Incidence and severity of adverse events (AEs)

    Time frame: Screening to 90 days post-last dose

    AE assessed by investigator exclusively related to subject's underlying disease or medical condition [graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0]. Any untoward medical occurrence in a clinical study participant, whether or not considered related to the medicinal product. Incidence and severity of AEs are assessed according to vital signs, laboratory variables, physical examination, electrocardiogram, etc.

Sponsors and collaborators

Lead sponsor

Hansoh BioMedical R&D Company

Industry

Registry information

Official study title

A Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics of HS-20093 in Patients With Advanced Solid Tumors Who Have Failed Adequate Standard Treatments or Are Intolerant to Standard Therapies

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 22, 2025
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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