Clinical Trials Logo

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


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

See also
  Status Clinical Trial Phase
Terminated NCT04551885 - FT516 in Combination With Monoclonal Antibodies in Advanced Solid Tumors Phase 1
Completed NCT05054348 - First-in-human Study of IO-108 as Single Agent and in Combination With a PD-1 Immune Check Point Inhibitor in Patients With Advanced Solid Tumors Phase 1
Active, not recruiting NCT04474470 - A Study to Evaluate NT219 Alone and in Combination With ERBITUX® (Cetuximab) in Adults With Advanced Solid Tumors and Head and Neck Cancer Phase 1/Phase 2
Recruiting NCT06088004 - Phase Ⅰ/Ⅱ Clinical Study to Evaluate ABO2011 Monotherapy in Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT05055609 - Open-Label, Dose-Escalation With Expansion to Assess the Safety, Tolerability, and PK of TRE-515 in Subjects With Solid Tumors Phase 1
Completed NCT04020185 - Safety and Efficacy Study of IMSA101 in Refractory Malignancies Phase 1/Phase 2
Withdrawn NCT05071846 - MVX-ONCO-2 in Advanced Solid Tumors Phase 1
Recruiting NCT05607199 - A First in Human Study of AUR 103 Calcium to Evaluate Safety, Pharmacokinetics and Pharmacodynamics Phase 1
Active, not recruiting NCT04552288 - Study of Benralizumab in People With Skin Side Effects Caused by Cancer Therapies Phase 2
Active, not recruiting NCT06026254 - A Rollover Study for Subjects Who Completed Participation in IMSA101-101 Trial Phase 1
Recruiting NCT06032845 - Cryoablation Combined With Tislelizumab Plus Lenvatinib In Previously Treated Solid Tumors (CASTLE-11) Phase 2
Recruiting NCT06144671 - GT201 Injection For The Treatment Of Advanced Solid Tumors Phase 1/Phase 2
Not yet recruiting NCT06398418 - R-5780-01 In Combination With PD-1 Checkpoint Inhibitors (Checkpoint Protein on Immune Cells Called T Cells) in Patients With Solid Tumors Phase 1
Recruiting NCT05276284 - Thiopurine Enhanced Mutations for PD-1/Ligand-1 Efficacy Phase 1/Phase 2
Recruiting NCT04121442 - Isunakinra Alone and in Combination With a PD-1/PD-L1 Inhibitor in Patients With Solid Tumors Phase 1/Phase 2
Active, not recruiting NCT04221204 - A Monotherapy in Subjects With Advanced Solid Tumors Phase 1
Terminated NCT03992326 - Adoptive Transfer Of Autologous Tumor-Infiltrating Lymphocytes in Solid Tumors Phase 1
Terminated NCT05435339 - A Study to Evaluate Safety, Tolerability, and Preliminary Effect of the GEN1053 Antibody on Malignant Solid Tumors as Monotherapy Phase 1/Phase 2
Recruiting NCT04981119 - Solid Tumor Analysis for HLA Loss of Heterozygosity (LOH) and Apheresis for CAR T- Cell Manufacturing
Recruiting NCT06075849 - Phase I Study to Evaluate Safety and Anti-tumor Activity of PB101, an Anti-angiogenic Immunomodulating Agent Phase 1