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

NCT07186452 | Recruiting Phase 1 FDA Drug

• 1 other identifier: HS-20093-111
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (2)

• Cmax of HS-20093 and free toxin

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

  Three treatment cycles, each cycle lasting for three weeks.

• AUC0-16d of HS-20093 and free toxin

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

  Three treatment cycles, each cycle lasting for three weeks.

Secondary Outcomes (7)

• Tmax of HS-20093 and free toxin

  Three treatment cycles, each cycle lasting for three weeks.

• t1/2 of HS-20093 and free toxin

  Three treatment cycles, each cycle lasting for three weeks.

• AUC0-∞ and AUC0-tau of HS-20093 and free toxin

  Three treatment cycles, each cycle lasting for three weeks.

• Cmin of HS-20093 and free toxin

  Three treatment cycles, each cycle lasting for three weeks.

• CL of HS-20093 and free toxin

  Three treatment cycles, each cycle lasting for three weeks.

Study Arms (1)

HS-20093 + Itraconazole

EXPERIMENTAL

Drug: HS-20093; Drug: Itraconazole

Interventions

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.

HS-20093 + Itraconazole

Itraconazole DRUG

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

HS-20093 + Itraconazole

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Hansoh BioMedical R&D Company: lead

Study Sites (1)

Hunan Cancer Hospital

Changsha, Hunan, 410013, China

RECRUITING

MeSH Terms

Interventions

Itraconazole

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2025
• First Posted: September 22, 2025
• Study Start: September 23, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: January 16, 2026

Record last verified: 2026-01

Locations

CN (1)