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

Sponsor: HotSpot Therapeutics, Inc

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05662397

Patient View

This Phase 1/2 study evaluates HST-1011, a CBL-B inhibitor, for advanced solid tumors. Phase 1 involves dose escalation of HST-1011 alone and with cemiplimab. Phase 2 assesses antitumor activity. Eligible patients are adults with specific relapsed/refractory tumors, measurable lesions, and ECOG status 0-1. Interventions include oral HST-1011 and IV cemiplimab.

Patient Parameters

Program Overview

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.

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.

Eligibility Criteria

Inclusion Criteria

  • Patient is at least 18 years of age.
  • Patient is capable of understanding and complying with protocol requirements.
  • Patient has signed and dated ICF.
  • Patient has a histologically confirmed, advanced solid tumor (metastatic, recurrent, and/or unresectable) in one of the following categories: 1) anti-PD-(L)1 relapsed/refractory; 2) platinum-resistant ovarian cancer; 4) anal cancer; 5) rectal cancer; or 6) castration-resistant prostate cancer
  • Patient has failed prior standard of care therapies appropriate for their metastatic disease.
  • Patient has at least 1 measurable non-central nervous system (CNS) lesions per RECIST 1.1.
  • Patient has provided consent for pre- and on-treatment biopsies.
  • Eastern Cooperative Performance Status of 0 or 1.

Key

Exclusion Criteria

  • Patient has active autoimmune disease or other medical conditions requiring chronic systemic steroid therapy at the time of screening.
  • Patient has an unacceptable intolerance to anti-PD(L)1 monoclonal antibody (Part B Only).
  • Patient has previously participated in a clinical study evaluating a CBL-B inhibitor.
  • Patients has untreated and/or symptomatic metastatic CNS disease.
  • Patient is currently taking any concomitant medications at Screening that have the potential to cause a clinically relevant drug-drug interaction with HST-1011.
  • Patients with a history of gastrointestinal disease that may affect absorption of the study drug, or patients who are not able to take oral medications.
  • Patient has an active infection requiring systemic therapy.
  • Patient has known or suspected infection with SARS-CoV-2 virus.

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