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

Solid Tumor, Adult Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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 B). Part A1 is a monotherapy dose escalation in which cohorts of patients will receive increasing doses of HST-1011. Upon completion of Part A1, an HST-1011 monotherapy dose optimization will commence (Part A2). Part B is a dose escalation of HST-1011 given in combination with the standard dose/regimen of cemiplimab. Dosing in Part B may commence prior to the completion of Part A1. 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05662397
Study type Interventional
Source HotSpot Therapeutics, Inc
Contact HotSpot Therapeutics
Phone +1 (617) 758-8998
Email Clin001_Information@hotspotthera.com
Status Recruiting
Phase Phase 1/Phase 2
Start date March 15, 2023
Completion date December 31, 2026
View Details
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