A Study of HST-1011 Given as Monotherapy and in Combination With an Anti-PD1 Antibody

Part of paid clinical trials in Sarasota, Florida.

Sponsor
HotSpot Therapeutics, Inc
Study ID
NCT05662397
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

  • Refractory Cancer
  • Relapsed Cancer
  • Solid Tumor, Adult

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • HST-1011 — DRUG
    HST-1011 given orally
  • Cemiplimab — BIOLOGICAL
    Cemiplimab administered via intravenous infusion in combination with HST-1011 given orally

Study Details

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.

Key Dates

Start date
Mar 15, 2023
Status verified
Feb 2025
Primary completion
Dec 31, 2025
Completion
Dec 31, 2026

Study Design

Enrollment
77 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: HST-1011 Monotherapy Dose Escalation (Part A1)
    Multiple dose levels of HST-1011 to be evaluated.
  • Experimental: HST-1011 Monotherapy Dose Optimization (Part A2)
    Evaluation of HST-1011 monotherapy dose/dose regimen.
  • Experimental: HST-1011 Dose Escalation in Combination with cemiplimab (Part B1)
    Multiple dose levels of HST-1011 to be evaluated in combination with cemiplimab.
  • Experimental: HST-1011 Dose Optimization in Combination with Cemiplimab (Part B2)
    Evaluation of HST-1011 in combination with cemiplimab.

Primary Outcome Measure

Evaluate the safety and tolerability of escalating doses of single-agent HST-1011 in Part A1 or in combination with cemiplimab in Part B1. [ Time Frame: 12 months ]

Locations (8)

FacilityCityStateZIPSite coordinators
Florida Cancer SpecialistsSarasotaFlorida34232-
Comprehensive Cancer Centers of NevadaLas VegasNevada89169-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10087-
Montefiore Einstein Comprehensive Cancer CenterThe BronxNew York10461-
Providence Cancer Institute of OregonPortlandOregon97213-
Abramson Cancer CenterPhiladelphiaPennsylvania19104-
University of Pittsburgh (UPMC), Hillman Cancer CenterPittsburghPennsylvania15232-
The University of Texas MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Sarasota, FL

By research site
Florida Cancer Specialists· Sarasota, FLComprehensive Cancer Centers of Nevada· Las Vegas, NVMemorial Sloan Kettering Cancer Center· New York, NYMontefiore Einstein Comprehensive Cancer Center· The Bronx, NYProvidence Cancer Institute of Oregon· Portland, ORAbramson Cancer Center· Philadelphia, PA

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