Spots Global Cancer Trial Database for 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
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Trial Identification
Brief Title: 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
Official Title: A Phase 1b, Open-Label, Dose-Escalation, Dose-Expansion, and Dose-Randomization Study of IO 108 as Monotherapy and in Combination With Either Pembrolizumab or Cemiplimab in Adult Patients With Advanced Solid Tumors
Study ID: NCT05054348
Conditions
Study Description
Brief Summary: 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.
Detailed Description: In the Part 1 Dose Escalation, safety and tolerability of varying doses of IO-108 as monotherapy or in combination with pembrolizumab will be studied, in order to determine a proposed RP2D. In Part 2 Dose Expansion, patients with various types of solid tumors will be dosed with either IO-108 alone or in combination with either pembrolizumab or cemiplimab in order to study safety, tolerability and preliminary efficacy of IO-108 monotherapy and combination with a PD-1 inhibitor. In Part 3, a tumor type that has been studied in the Dose Expansion will be selected and patients will be randomized into 2 doses of IO-108 in order to explore safety, toxicity, efficacy relationship with exposure, in order to explore different doses of IO-108 that is safe and efficacious. Safety, PK, PD biomarkers and efficacy will be studied.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Arizona Oncology Associates, PC-HOPE (140) (USOR SITE), Tucson, Arizona, United States
Beverly HIlls Cancer Center (129), Beverly Hills, California, United States
Rocky Mountain Cancer Centers, LLP (141) (USOR SITE), Lone Tree, Colorado, United States
University of Florida (125), Gainesville, Florida, United States
Florida Cancer Specialists (134), Lake Mary, Florida, United States
Memorial Cancer Institute (146), Pembroke Pines, Florida, United States
Florida Cancer Specialists & Research Institute (103), Sarasota, Florida, United States
Hematology Oncology (136), Stuart, Florida, United States
Indiana University Melvin and Bren Simon Comprehensive Cancer Center (123), Indianapolis, Indiana, United States
Maryland Oncology Hematology, PA (145) (USOR SITE), Columbia, Maryland, United States
Karmanos Cancer Institute (126), Detroit, Michigan, United States
St. Vincent - Frontier Cancer Center (135), Billings, Montana, United States
NYU Langone Health (131), New York, New York, United States
Carolina BioOncology (102), Huntsville, North Carolina, United States
Gabrail Cancer Center (128), Canton, Ohio, United States
Oncology Hematology Care Clinical Trials, LLC (144) (USOR SITE), Cincinnati, Ohio, United States
Providence Cancer Institute (104), Portland, Oregon, United States
UPMC Hillman Cancer Center (105), Pittsburgh, Pennsylvania, United States
Texas Oncology - Austin (142) (USOR SITE), Austin, Texas, United States
Texas Oncology - Baylor Charles A. (143) (USOR SITE), Dallas, Texas, United States
MD Anderson Cancer Center (101), Houston, Texas, United States
Oncology Consultants, P.A. (138), Houston, Texas, United States
NEXT Oncology-Virginia (121), Fairfax, Virginia, United States
Swedish Cancer Institute (147), Seattle, Washington, United States
Contact Details
Name: Wen Hong Lin, MD
Affiliation: Immune-Onc Therapeutics
Role: STUDY_DIRECTOR
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