Clinical trial · Interventional
A Study of HST-1011 Given as Monotherapy and in Combination With an Anti-PD1 Antibody
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
NCT05662397CI-TRIAL-00085483active not recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Refractory Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Relapsed Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Solid Tumor, Adult | Adult Solid Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cemiplimab | Biological | Cemiplimab | ALIAS |
| HST-1011 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- HST-1011 Monotherapy Dose Escalation (Part A1)
- description
- Multiple dose levels of HST-1011 to be evaluated.
- interventionNames
- Drug: HST-1011
- type
- EXPERIMENTAL
- label
- HST-1011 Monotherapy Dose Optimization (Part A2)
- description
- Evaluation of HST-1011 monotherapy dose/dose regimen.
- interventionNames
- Drug: HST-1011
- type
- EXPERIMENTAL
- label
- HST-1011 Dose Escalation in Combination with cemiplimab (Part B1)
- description
- Multiple dose levels of HST-1011 to be evaluated in combination with cemiplimab.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.