First-in-human Study of IO-108 as Single Agent and in Combination With a PD-1 Immune Check Point Inhibitor in Patients With Advanced Solid Tumors

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Immune-Onc Therapeutics
Study ID
NCT05054348
Phase
PHASE1
Status
Completed

Conditions

  • Solid Tumor, Adult

Eligibility Criteria

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

Interventions

  • IO-108 — BIOLOGICAL
    IO-108 given as monotherapy
  • IO-108 + pembrolizumab combination therapy — BIOLOGICAL
    IO-108 and fixed dose pembrolizumab combination therapy
  • IO-108 + cemiplimab combination therapy — BIOLOGICAL
    IO-108 and fixed dose cemiplimab combination therapy

Study Details

The goal of the clinical trial is to learn about safety, tolerability and preliminary efficacy of IO-108 as monotherapy or in combination with a PD-1 inhibitor in patients with advanced, metastatic solid tumors, and to find a dose of IO-108 that is safe and efficacious to be tested in patients with various solid tumors.

Key Dates

Start date
Sep 30, 2021
Status verified
Mar 2024
Primary completion
Apr 29, 2024
Completion
May 31, 2024

Study Design

Enrollment
91 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: IO-108 Monotherapy
    Treatment of patients with advanced solid tumors with IO-108 monotherapy
  • Experimental: IO-108 + pembrolizumab combination therapy
    Treatment of patients with advanced solid tumors with IO-108 in combination with a fixed dose of pembrolizumab
  • Experimental: IO-108 + cemiplimab combination therapy
    Treatment of patients with advanced solid tumors with IO-108 in combination with a fixed dose of cemiplimab

Primary Outcome Measure

Incidence of treatment-emergent and serious adverse events in patients treated with IO-108 and IO-108+pembrolizumab [ Time Frame: From first dose of IO-108 until the end of treatment which is up to 2 years from the first treatment date or disease progression whichever is earlier ]

Locations (24)

FacilityCityStateZIPSite coordinators
Arizona Oncology Associates, PC-HOPE (140) (USOR SITE)TucsonArizona85711-
Beverly HIlls Cancer Center (129)Beverly HillsCalifornia90211-
Rocky Mountain Cancer Centers, LLP (141) (USOR SITE)Lone TreeColorado80124-
University of Florida (125)GainesvilleFlorida32611-
Florida Cancer Specialists (134)Lake MaryFlorida32746-
Memorial Cancer Institute (146)Pembroke PinesFlorida33021-
Florida Cancer Specialists & Research Institute (103)SarasotaFlorida34232-
Hematology Oncology (136)StuartFlorida34952-
Indiana University Melvin and Bren Simon Comprehensive Cancer Center (123)IndianapolisIndiana46202-
Maryland Oncology Hematology, PA (145) (USOR SITE)ColumbiaMaryland21044-
Karmanos Cancer Institute (126)DetroitMichigan48201-
St. Vincent - Frontier Cancer Center (135)BillingsMontana59102-
NYU Langone Health (131)New YorkNew York10016-
Carolina BioOncology (102)HuntsvilleNorth Carolina28078-
Gabrail Cancer Center (128)CantonOhio44718-
Oncology Hematology Care Clinical Trials, LLC (144) (USOR SITE)CincinnatiOhio45242-
Providence Cancer Institute (104)PortlandOregon97213-
UPMC Hillman Cancer Center (105)PittsburghPennsylvania15209-
Texas Oncology - Austin (142) (USOR SITE)AustinTexas78705-
Texas Oncology - Baylor Charles A. (143) (USOR SITE)DallasTexas75246-
MD Anderson Cancer Center (101)HoustonTexas77030-
Oncology Consultants, P.A. (138)HoustonTexas77030-
NEXT Oncology-Virginia (121)FairfaxVirginia22031-
Swedish Cancer Institute (147)SeattleWashington98104-

Find similar trials in Tucson, AZ

By research site
Arizona Oncology Associates, PC-HOPE (140) (USOR SITE)· Tucson, AZBeverly HIlls Cancer Center (129)· Beverly Hills, CARocky Mountain Cancer Centers, LLP (141) (USOR SITE)· Lone Tree, COUniversity of Florida (125)· Gainesville, FLFlorida Cancer Specialists (134)· Lake Mary, FLMemorial Cancer Institute (146)· Pembroke Pines, FL

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