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

• Status: Not yet recruiting
• Trial end date: 2026-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: HotSpot Therapeutics, Inc
• Treatments: Cemiplimab

Criteria

Key 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 histologically confirmed advanced solid tumor, who is 1) anti-PD(L)1 relapsed/refractory; 2) platinum-resistant ovarian; 3) anal and rectal cancer; or 4) castrate-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.