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

Completed · Phase 1

Conditions studied: Solid Tumor, Adult

In brief

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 facts

Study ID

NCT05054348

Run by

Immune-Onc Therapeutics

People needed

91

Starts

2021-09-30

Expected to finish

2024-05-31

Last updated by the study team

2024-06-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must be ≥18.
• Has any histologically- or cytologically confirmed advanced/metastatic solid tumor by pathology report and has received, has been intolerant to, or has been ineligible for standard systemic therapy known to confer clinical benefit. Solid tumors of any type are eligible for enrollment. Patients with asymptomatic central nervous system (CNS) disease may be enrolled.
• Patient has measurable disease by Response Evaluation in Solid Tumors version 1.1 (RECIST 1.1) as assessed by local site.
• Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
• Patients must have adequate hepatic function and renal function.

You may not qualify if…

• Patients who previously received a monoclonal antibody therapy targeting LILRB2/ Immunoglobulin-Like Transcript 4 (ILT4) (including IO-108).
• Patients who received a biologic systemic anti-cancer therapy <4 weeks or 5 half-lives prior to their first day of study drug administration, or a small molecule systemic anti-cancer therapy or definitive radiotherapy <2 weeks or 5 half-lives prior to their first day of study drug administration or have not recovered to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0 Grade 1 or better from any adverse events (AEs) that were due to prior cancer therapeutics. Palliative radiation is allowed within 2 weeks of the first day of study drug administration.
• Requires systemic corticosteroids at a dose of >10 mg prednisone or the dose equivalent to other systemic corticosteroid.
• History of radiation pneumonitis, non-infectious pneumonitis or interstitial lung disease.
• Symptomatic CNS spread of tumor.
• History of Grade > 3 immune-related AEs with any prior immunotherapy.
• Patients with uncontrolled, active infection.
• Patients with known hypersensitivity to any of the components of the IO-108 formulation or pembrolizumab.
• Active known malignancy with the exception of any of the following:
• Adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or in situ cervical cancer;
• Low-risk prostate cancer for which observation or hormonal therapy only is indicated;
• Any other malignancy treated with curative intent with the last treatment completed ≥6 months before study initiation (with the exception of hormonal therapies when indicated).
• Patients with New York Heart Association (NYHA) Class III or IV congestive heart failure (CHF) or left ventricular ejection fraction (LVEF) <40% by echocardiogram (ECHO) or multi-gated acquisition (MUGA) scan ≤28 days prior to Cycle 1 Day 1 (C1D1).
• Any of the following in the previous 6 months: myocardial infarction, congenital long QT syndrome, Torsades de pointes, clinically significant arrhythmias (including sustained ventricular tachyarrhythmia and ventricular fibrillation), and left anterior hemiblock (bifascicular block), unstable angina, coronary/peripheral artery bypass graft, symptomatic CHF (NYHA class III or IV), cerebrovascular accident, transient ischemic attack, or pulmonary embolism. Patients with asymptomatic right bundle branch block or controlled atrial fibrillation are allowed.
• Ongoing cardiac dysrhythmias of Grade 2 or higher per NCI CTCAE, Version 5.0.
• Known active bacterial, viral, and/or fungal infection including hepatitis B (HBV), hepatitis C, human immunodeficiency virus (HIV), severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) or acquired immunodeficiency syndrome (AIDS)-related illness.
• Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for entry into this study.

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.