A Study of HST-1011 Given as Monotherapy and in Combination With an Anti-PD1 Antibody
NCT ID: NCT05662397
Last Updated: 2025-02-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
77 participants
INTERVENTIONAL
2023-03-15
2026-12-31
Brief Summary
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Detailed Description
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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 B1 and B2).
Part A1 is a monotherapy dose escalation in which cohorts of patients will receive increasing doses of HST-1011. Upon completion of Part A1 dose escalation, an HST-1011 monotherapy dose optimization will commence (Part A2).
Part B1 is a dose escalation of HST-1011 given in combination with the standard dose/regimen of cemiplimab. Dosing in Part B1 may commence prior to the completion of Part A1. Upon completion of Part B1 dose escalation, an HST-1011 dose optimization in combination with cemiplimab will commence (Part B2).
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.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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HST-1011 Monotherapy Dose Escalation (Part A1)
Multiple dose levels of HST-1011 to be evaluated.
HST-1011
HST-1011 given orally
HST-1011 Monotherapy Dose Optimization (Part A2)
Evaluation of HST-1011 monotherapy dose/dose regimen.
HST-1011
HST-1011 given orally
HST-1011 Dose Escalation in Combination with cemiplimab (Part B1)
Multiple dose levels of HST-1011 to be evaluated in combination with cemiplimab.
HST-1011
HST-1011 given orally
Cemiplimab
Cemiplimab administered via intravenous infusion in combination with HST-1011 given orally
HST-1011 Dose Optimization in Combination with Cemiplimab (Part B2)
Evaluation of HST-1011 in combination with cemiplimab.
HST-1011
HST-1011 given orally
Cemiplimab
Cemiplimab administered via intravenous infusion in combination with HST-1011 given orally
Interventions
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HST-1011
HST-1011 given orally
Cemiplimab
Cemiplimab administered via intravenous infusion in combination with HST-1011 given orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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HotSpot Therapeutics, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Alison O'Neill, MD
Role: STUDY_DIRECTOR
HotSpot Therapeutics, Inc
Locations
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Florida Cancer Specialists
Sarasota, Florida, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Montefiore Einstein Comprehensive Cancer Center
The Bronx, New York, United States
Providence Cancer Institute of Oregon
Portland, Oregon, United States
Abramson Cancer Center
Philadelphia, Pennsylvania, United States
University of Pittsburgh (UPMC), Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
University of Ottawa
Ottawa, Ontario, Canada
Princess Margaret Cancer Center
Toronto, Ontario, Canada
NEXT Oncology Barcelona IOB Hospital Quirónsalud
Barcelona, , Spain
Clínica Universidad de Navarra
Madrid, , Spain
NEXT Oncology Hospital Universitario Quirónsalud Madrid
Madrid, , Spain
Clínica Universidad de Navarra (Pamplona)
Pamplona, , Spain
Countries
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Other Identifiers
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Clin-001
Identifier Type: -
Identifier Source: org_study_id
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