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

Clin-001

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.

2023-03-15

2025-12-31

2026-12-31

Recruiting

Early phase I

203

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 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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 203, 'type': 'ESTIMATED'}}

2024-01-10