NCT06882135

HW071021 Monotherapy in Patients With Advanced Solid Tumors

A Phase I Open-Label, Dose-Escalation and Dose-Expansion Trial Evaluating Safety, Pharmacokinetics, and Efficacy of HW071021 in Patients With Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 76 (estimated)
• Sponsor: Wuhan Humanwell Innovative Drug Research and Development Center Limited Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase I open-label study that will evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of HW071021 monotherapy in patients with advanced solid tumors.

Detailed description

This trial is an open-label, dose-escalation/expansion first-in-human study of HW071021, divided into two phases: Phase 1 (Dose Escalation): This phase plans to enroll patients with advanced solid tumors who have no standard treatment, have failed standard treatment, or are ineligible for standard treatment. Patients will receive oral monotherapy with HW071021 at pre-specified escalating doses (single-dose and continuous-dose administration). The objectives are to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of HW071021 in patients. Selected subjects in Phase 1 will undergo a QT/QTc study to assess the drug's effects on QT/QTc intervals and cardiac safety. Phase 2 (Dose Expansion): This phase intends to enroll patients with advanced solid tumors who have no standard treatment, have failed standard treatment, or are ineligible for standard treatment. Patients will receive continuous administration of HW071021 to provide additional clinical data for determining the Phase 2 recommended dose (P2RD) and potential indications.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	HW071021 Tablets	Administered orally at pre-specified doses once or twice daily.

Timeline

• Start date: 2025-05-28
• Primary completion: 2026-09-30
• Completion: 2027-02-28
• First posted: 2025-03-18
• Last updated: 2025-12-29

Locations

1 site across 1 country: China