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A Study of HST-1011 Given as Monotherapy and in Combination With an Anti-PD1 Antibody
NCT05662397 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- BIOLOGICAL Cemiplimab
- DRUG HST-1011
Study Locations (14)
Other
- NEXT Oncology Barcelona IOB Hospital Quirónsalud — Barcelona
- Clínica Universidad de Navarra — Madrid
- NEXT Oncology Hospital Universitario Quirónsalud Madrid — Madrid
- Clínica Universidad de Navarra (Pamplona) — Pamplona
New York
- Memorial Sloan Kettering Cancer Center — New York
- Montefiore Einstein Comprehensive Cancer Center — The Bronx
Pennsylvania
- Abramson Cancer Center — Philadelphia
- University of Pittsburgh (UPMC), Hillman Cancer Center — Pittsburgh
Ontario
- University of Ottawa — Ottawa
- Princess Margaret Cancer Center — Toronto
Florida
- Florida Cancer Specialists — Sarasota
Nevada
- Comprehensive Cancer Centers of Nevada — Las Vegas
Oregon
- Providence Cancer Institute of Oregon — Portland
Texas
- The University of Texas MD Anderson Cancer Center — Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 77 participants |
| Start Date | 2023-03-15 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05662397
The ClinicalTrials.gov registry entry for NCT05662397 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 77 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is HotSpot Therapeutics, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Solid Tumor, Adult appearing as the primary indexed condition, and to 2 interventions — of which Cemiplimab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05662397 reports 14 study locations spanning 8 distinct geographic areas — top geographies include Other, New York, Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05662397 about?
NCT05662397 is a clinical study titled "A Study of HST-1011 Given as Monotherapy and in Combination With an Anti-PD1 Antibody". 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.
What is the current status of trial NCT05662397?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 77 participants. The study started on 2023-03-15. Estimated completion is 2026-12-31.
What conditions does trial NCT05662397 study?
This clinical trial studies the following conditions: Solid Tumor, Adult, Refractory Cancer, Relapsed Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05662397?
The interventions under investigation include: Cemiplimab (BIOLOGICAL), HST-1011 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05662397?
This trial is sponsored by HotSpot Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05662397 being conducted?
This trial has 14 study locations across Florida, Nevada, New York, Oregon, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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