A First-in-human Study of PRTH-101 Monotherapy +/- Pembrolizumab in Subjects With Advanced Malignancies

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Incendia Therapeutics
Study ID
NCT05753722
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • PRTH-101 — BIOLOGICAL
    PRTH-101 is a humanized immunoglobulin gamma-1 (IgG1) monoclonal antibody
  • Pembrolizumab — BIOLOGICAL
    PRTH-101 in combination with Pembrolizumab

Study Details

The goal of this Open-Label Study is to evaluate the safety and tolerability of PRTH-101 alone or in combination with pembrolizumab in adults with advance or metastatic solid tumors.

Key Dates

Start date
Mar 3, 2023
Status verified
Sep 2025
Primary completion
Sep 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
270 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: PRTH-101
    Mono-therapy
  • Experimental: PRTH-101 with Pembrolizumab
    Combo therapy

Primary Outcome Measure

Evaluate the Adverse Events (AEs), including Serious Adverse Events (SAEs), that occur in patients treated with PRTH-101 [ Time Frame: Up to 4 years ]

Central Contacts

Locations (11)

FacilityCityStateZIPSite coordinators
Honor Health Research InstituteScottsdaleArizona85258
Elise Johnson
Frank Yung-Chin Tsai, MD (PRINCIPAL_INVESTIGATOR)
Yale Cancer CenterNew HavenConnecticut06511
Alicia Appiah-Chin
Patricia LoRusso, DO (PRINCIPAL_INVESTIGATOR)
Mass General Cancer CenterBostonMassachusetts02114
Kyndall Hailey
Aparna Parikh, MD (PRINCIPAL_INVESTIGATOR)
Providence Cancer Institute Franz ClinicPortlandOregon97213
Annie Long
Rachel Sanborn, MD (PRINCIPAL_INVESTIGATOR)
University of Pittsburgh Medical Center Hillman Cancer CenterPittsburghPennsylvania15232-
Vanderbilt-Ingram Cancer CenterNashvilleTennessee27232
Rebekah Caza
Jordan Berlin, MD (PRINCIPAL_INVESTIGATOR)
NEXT HoustonHoustonTexas77054
Emma Morales
Jennifer Segar, MD (PRINCIPAL_INVESTIGATOR)
The University of Texas MD Anderson Cancer CenterHoustonTexas77030
Julia Moore
Funda Meric-Bernstam, MD (PRINCIPAL_INVESTIGATOR)
Next OncologyIrvingTexas75039
Selena Morales
Shiraj Sen, MD, PhD (PRINCIPAL_INVESTIGATOR)
NEXT OncologySan AntonioTexas78229
Jordan Georg
David Sommerhalder, MD (PRINCIPAL_INVESTIGATOR)
Next OncologyFairfaxVirginia22031
Maybelle De La Rosa
Alex Spira, MD,PhD,FACP (PRINCIPAL_INVESTIGATOR)

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Honor Health Research Institute· Scottsdale, AZYale Cancer Center· New Haven, CTMass General Cancer Center· Boston, MAProvidence Cancer Institute Franz Clinic· Portland, ORUniversity of Pittsburgh Medical Center Hillman Cancer Center· Pittsburgh, PAVanderbilt-Ingram Cancer Center· Nashville, TN

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