NCT05662397

A Study of HST-1011 Given as Monotherapy and in Combination With an Anti-PD1 Antibody

An Open Label, Phase 1/2 Study of HST-1011 Given as Monotherapy and in Combination With an Anti-PD1 Antibody in Patients With Advanced Solid Tumors

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 77 (actual)
• Sponsor: HotSpot Therapeutics, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1/2 study of HST-1011, a CBL-B inhibitor, being developed for the treatment of patients with advanced solid tumors, who relapsed while on or are refractory to approved anti-PD(L)1 therapies or other standard of care.

Detailed description

This is a Phase 1/2 study of HST-1011, a CBL-B inhibitor, being developed for the treatment of patients with advanced solid tumors, who relapsed while on or are refractory to approved anti-PD(L)1 therapies or other standard of care. In Phase 1 patients will receive HST-1011 as either monotherapy (Parts A1 and A2) or in combination with the anti-PD1 antibody, cemiplimab (Part B1 and B2). Part A1 is a monotherapy dose escalation in which cohorts of patients will receive increasing doses of HST-1011. Upon completion of Part A1 dose escalation, an HST-1011 monotherapy dose optimization will commence (Part A2). Part B1 is a dose escalation of HST-1011 given in combination with the standard dose/regimen of cemiplimab. Dosing in Part B1 may commence prior to the completion of Part A1. Upon completion of Part B1 dose escalation, an HST-1011 dose optimization in combination with cemiplimab will commence (Part B2). Phase 2 will evaluate the preliminary antitumor activity of HST-1011 in combination with anti-PD(L)1 antibody or other standard of care therapies.

Conditions

• Solid Tumor, Adult
• Relapsed Cancer
• Refractory Cancer

Interventions

Type	Name	Description
DRUG	HST-1011	HST-1011 given orally
BIOLOGICAL	Cemiplimab	Cemiplimab administered via intravenous infusion in combination with HST-1011 given orally

Timeline

• Start date: 2023-03-15
• Primary completion: 2025-12-31
• Completion: 2026-12-31
• First posted: 2022-12-22
• Last updated: 2025-02-04

Locations

14 sites across 3 countries: United States, Canada, Spain

Regulatory

• FDA-regulated drug study