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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05054348
Other study ID # IO-108-CL-001
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date September 30, 2021
Est. completion date May 31, 2024

Study information

Verified date March 2024
Source Immune-Onc Therapeutics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 91
Est. completion date May 31, 2024
Est. primary completion date April 29, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Patients must be =18. 2. 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. 3. Patient has measurable disease by Response Evaluation in Solid Tumors version 1.1 (RECIST 1.1) as assessed by local site. 4. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. 5. Patients must have adequate hepatic function and renal function. Exclusion Criteria: 1. Patients who previously received a monoclonal antibody therapy targeting LILRB2/ Immunoglobulin-Like Transcript 4 (ILT4) (including IO-108). 2. 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. 3. Requires systemic corticosteroids at a dose of >10 mg prednisone or the dose equivalent to other systemic corticosteroid. 4. History of radiation pneumonitis, non-infectious pneumonitis or interstitial lung disease. 5. Symptomatic CNS spread of tumor. 6. History of Grade > 3 immune-related AEs with any prior immunotherapy. 7. Patients with uncontrolled, active infection. 8. Patients with known hypersensitivity to any of the components of the IO-108 formulation or pembrolizumab. 9. Active known malignancy with the exception of any of the following: 1. Adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or in situ cervical cancer; 2. Low-risk prostate cancer for which observation or hormonal therapy only is indicated; 3. 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). 10. 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). 11. 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. 12. Ongoing cardiac dysrhythmias of Grade 2 or higher per NCI CTCAE, Version 5.0. 13. 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. 14. 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.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
IO-108
IO-108 given as monotherapy
IO-108 + pembrolizumab combination therapy
IO-108 and fixed dose pembrolizumab combination therapy
IO-108 + cemiplimab combination therapy
IO-108 and fixed dose cemiplimab combination therapy

Locations

Country Name City State
United States Texas Oncology - Austin (142) (USOR SITE) Austin Texas
United States Beverly HIlls Cancer Center (129) Beverly Hills California
United States St. Vincent - Frontier Cancer Center (135) Billings Montana
United States Gabrail Cancer Center (128) Canton Ohio
United States Oncology Hematology Care Clinical Trials, LLC (144) (USOR SITE) Cincinnati Ohio
United States Maryland Oncology Hematology, PA (145) (USOR SITE) Columbia Maryland
United States Texas Oncology - Baylor Charles A. (143) (USOR SITE) Dallas Texas
United States Karmanos Cancer Institute (126) Detroit Michigan
United States NEXT Oncology-Virginia (121) Fairfax Virginia
United States University of Florida (125) Gainesville Florida
United States MD Anderson Cancer Center (101) Houston Texas
United States Oncology Consultants, P.A. (138) Houston Texas
United States Carolina BioOncology (102) Huntsville North Carolina
United States Indiana University Melvin and Bren Simon Comprehensive Cancer Center (123) Indianapolis Indiana
United States Florida Cancer Specialists (134) Lake Mary Florida
United States Rocky Mountain Cancer Centers, LLP (141) (USOR SITE) Lone Tree Colorado
United States NYU Langone Health (131) New York New York
United States Memorial Cancer Institute (146) Pembroke Pines Florida
United States UPMC Hillman Cancer Center (105) Pittsburgh Pennsylvania
United States Providence Cancer Institute (104) Portland Oregon
United States Florida Cancer Specialists & Research Institute (103) Sarasota Florida
United States Swedish Cancer Institute (147) Seattle Washington
United States Hematology Oncology (136) Stuart Florida
United States Arizona Oncology Associates, PC-HOPE (140) (USOR SITE) Tucson Arizona

Sponsors (2)

Lead Sponsor Collaborator
Immune-Onc Therapeutics Regeneron Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Receptor occupancy of IO-108 in IO-108 monotherapy and IO-108+pembrolizumab To assess target engagement via determining Leukocyte Immunoglobulin-Like Receptor subfamily B2 (LILRB2) occupancy by IO-108 in peripheral blood myeloid cells, as expressed by % of target receptor engagement From the first dose of IO-108 till 21 days after
Primary Incidence of treatment-emergent and serious adverse events in patients treated with IO-108 and IO-108+pembrolizumab safety and tolerability as measured by the incidence of treatment-emergent adverse events and serious adverse events 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
Primary Determine MTD (maximum tolerated dose) through assessment of dose-limiting toxicities (DLT) MTD will be determined through observation of pre-determined DLTs in each dose cohort From the first dose of IO-108 until 21 days post-treatment
Primary Assess safety and tolerability of the IO-108 RP2D as monotherapy or in combination with either pembrolizumab or cemiplimab in patients with solid tumors safety and tolerability as measured by the incidence of treatment-emergent adverse events and discontinuation due to TEAEs From the first dose of IO-108 until the end of treatment which is up to 2 years from the first treatment or disease progression, whicheer is earlier
Secondary Maximum plasma concentration (Cmax) of IO-108 Characterize the Cmax of IO-108 by successive sampling of blood at pre-specified time points From the first dose of IO-108 until day 15 post-treatment
Secondary Steady state concentration of IO-108 Characterize steady state concentration of IO-108 by successive sampling of blood at pre-specified time points From the second dose of IO-108 until the last treatment which is up to 2 years from the first treatment date
Secondary Immunogenicity of IO-108 and IO-108+pembrolizumab Determine the incidence/titer of anti-drug antibodies (ADAs) against IO-108 and pembrolizumab (in combination treatment) From the first dose until 30 days after the last treatment
Secondary Anti-tumor activity of IO-108 and IO-108+pembrolizumab Determine preliminary rates of response after treatment with IO-108 From the date of first treatment until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to estimated period of 48 months
Secondary Determine disease control rates of IO-108 as monotherapy or in combination with either pembrolizumab or cemiplimab Disease control rate is defined as the percentage of patients with complete response, partial response or stable disease maintained for at least 3 months From the first dose of IO-108 until the last treatment which is up to 2 years from the first treatment or disease progression whichever is earlier
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