NCT07413328

HWS116 Monotherapy in Patients With Advanced Solid Tumors

A Phase I, Single-Arm, Open-Label, Dose-Escalation and Expansion Study of HWS116 Injection in Advanced Solid Tumors

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (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 HWS116 monotherapy in patients with advanced solid tumors.

Detailed description

This trial is an open-label, dose-escalation/expansion first-in-human study of HWS116, divided into two parts: Part 1 (Dose Escalation): This part 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 monotherapy with HWS116 at pre-specified escalating doses. The objectives are to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of HWS116 in patients. Part 2 (Dose Expansion): This part 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 HWS116 to provide additional clinical data for evaluating preliminary efficacy and determining the Phase 2 recommended dose (P2RD) and potential indications.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	HWS116 Injection	Administered intravenous infusion at pre-specified doses every two weeks.

Timeline

• Start date: 2026-02-04
• Primary completion: 2027-08-31
• Completion: 2028-02-28
• First posted: 2026-02-17
• Last updated: 2026-02-27

Locations

1 site across 1 country: China