Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05662397 · ClinicalTrials.gov registry record · Phase 1
A Study of HST-1011 Given as Monotherapy and in Combination With an Anti-PD1 Antibody
A Phase 1 study of Solid Tumor, Adult and Refractory Cancer, sponsored by HotSpot Therapeutics.
- Active
- Registry status
- Phase 1
- Development phase
- 77
- Enrollment target
- 14
- Study locations
NCT05662397: Active Phase 1 study of Solid Tumor, Adult and Refractory Cancer, sponsored by HotSpot Therapeutics.
NCT05662397 is a Phase 1 study of Solid Tumor, Adult and Refractory Cancer that is active but no longer recruiting, run by HotSpot Therapeutics. The registered enrollment target is 77 participants, below the 189-participant average among 72 other Solid Tumor, Adult trials with a reported enrollment target (59% lower). The trial reports 14 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05662397, a Phase 1 study of Solid Tumor, Adult and Refractory Cancer, is active but no longer recruiting, sponsored by HotSpot Therapeutics.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 77 participants
- Enrollment target
- 14
- Study locations
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.
Primary Outcome
Number of participants with DLTs, with Adverse Events (TEAEs, SAEs), with abnormal clinically significant vital signs, Electrocardiograms (ECGs), with abnormal physical examination findings, and abnormal laboratory test results.
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 |
What the registry record for NCT05662397 still lists
NCT05662397 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 77 participants, a relatively small participant target, below the 189-participant average among 72 other Solid Tumor, Adult trials with a reported enrollment target (59% lower).
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.
NCT05662397 lists 14 locations in 8 states (Other, New York, Pennsylvania).
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.
What interventions are being tested in trial NCT05662397?
The interventions under investigation include: Cemiplimab (BIOLOGICAL), HST-1011 (DRUG).
Who is sponsoring clinical trial NCT05662397?
This trial is sponsored by HotSpot Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Solid Tumor, Adult
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05662397's enrollment target sits among peer trials
77 50th of 72 higher than 23 of 72 other Solid Tumor, Adult trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Solid Tumor, Adult trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Study of CRX100 as Monotherapy and in Combination With Pembrolizumab in Patients With Advanced Solid Malignancies
RECRUITING · Phase 1
-
Open-Label, Dose-Escalation With Expansion to Assess the Safety, Tolerability, and PK of TRE-515 in Subjects With Solid Tumors
RECRUITING · Phase 1
-
A Study of BI-1206 in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors
RECRUITING · Phase 1
-
Phase 1 Study to Investigate TCRTs KRAS Mutation in Unresectable, Advanced, and/or Metastatic Solid Tumors
RECRUITING · Phase 1
-
Study Assessing MTD, Safety, Tolerability, PK and Anti-tumor Effects of LNS8801alone and With Pembrolizumab
RECRUITING · Phase 1
-
A Study to Investigate the Safety and Efficacy of NST-628 Oral Tablets in Subjects With Solid Tumors
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02127398 · 77 participants · Phase 2
Stool Transplants to Treat Refractory Clostridium Difficile Colitis
- NCT04159103 · 77 participants · Phase 1
Open-Label Study of mRNA-3927 in Participants With Propionic Acidemia
- NCT04683003 · 77 participants · Phase 3
A Study of TAK-755 in Participants With Congenital Thrombotic Thrombocytopenic Purpura
- NCT05004116 · 77 participants · Phase 1
A Study of Repotrectinib in Combination With Chemotherapy in Children and Young Adults With Solid Tumor Cancer
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI