Dose-Escalation and Dose-Expansion Study of IO-202 and IO-202+Pembrolizumab in Solid Tumors

NCT05309187 | Completed Phase 1 FDA Drug

• 1 other identifier: IO-202-CL-002
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 10

Brief Summary

To assess safety and tolerability of increasing doses of IO-202 either as monotherapy or in combination with pembrolizumab in patients with advanced solid tumors, and select the recommended Phase 2 dose (RP2D).

Conditions

Solid Tumor, Adult

Keywords

IO-202

Outcome Measures

Primary Outcomes (3)

• Incidence of treatment-emergent and serious adverse events in patients treated with IO-202 and IO-202 + pembrolizumab

  safety and tolerability as measured by the incidence of treatment-emergent adverse events.

  From first dose of IO-202 until the end of treatment which is up to 2 years from the first treatment date

• Dose-limiting toxicities (DLTs) with IO-202 and IO-202 + pembrolizumab

  DLTs as measured by the incidence during Cycle 1.

  From the first dose of IO-202 and IO-202 + pembrolizumab until 21 days after 1st treatment

• Study discontinuations due to adverse events (AEs)

  The number of study discontinuations due to AEs

  From the first dose of IO-202 IO-202 and IO-202 + pembrolizumab up to 2 years from the first treatment.

Secondary Outcomes (4)

• Maximum serum concentration (Cmax) of IO-202

  From the first dose of IO-202 until Cycle 5, Day 1

• Minimum concentration of IO-202

  From the first dose of IO-202 until the last treatment which is up to 2 years from the first treatment date

• Immunogenicity of IO-202 and IO-202 + pembrolizumab

  From the first dose until 24 months after the last treatment

• Anti-tumor activity of IO-202 and IO-202 + pembrolizumab

  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 an estimated period of 24 months

Other Outcomes (1)

• Receptor occupancy in IO-202 monotherapy and IO-202 + pembrolizumab

  From the first dose of IO-202 till 21 days after

Study Arms (3)

IO-202 Monotherapy (dose escalation)

EXPERIMENTAL

Biological: IO-202

IO-202 dose escalation + pembrolizumab

EXPERIMENTAL

Increasing dose levels of IO-202 with fixed dose of pembrolizumab

Biological: IO-202 + pembrolizumab combination therapy

IO-202 + pembrolizumab combination therapy (dose expansion)

EXPERIMENTAL

RP2D + pembrolizumab combination therapy in solid tumor cohorts

Biological: RP2D of IO-202 + pembrolizumab combination therapy in multiple solid tumor types

Interventions

IO-202 BIOLOGICAL

IO-202 given as monotherapy

IO-202 Monotherapy (dose escalation)

IO-202 + pembrolizumab combination therapy BIOLOGICAL

IO-202 and fixed dose pembrolizumab combination therapy

Also known as: IO-202 + Keytruda combination therapy

IO-202 dose escalation + pembrolizumab

RP2D of IO-202 + pembrolizumab combination therapy in multiple solid tumor types BIOLOGICAL

Expansion cohorts of the RP2D of IO-202 and fixed dose pembrolizumab combination therapy in multiple tumor types.

Also known as: RP2D of IO-202 + Keytruda combination therapy

IO-202 + pembrolizumab combination therapy (dose expansion)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must be ≥18 years old.
• Part 1 - Dose Escalation: Subject must have any histologically or cytologically confirmed advanced or metastatic solid tumor and has received, has been intolerant to, or has been ineligible for standard systemic therapy known to confer clinical benefit.
• Part 2 - Dose Expansion: Subject must have failed at least one available therapy for the disease under study.
• Subject must have measurable disease per RECIST 1.1 as assessed by local clinical site.
• Subject must have an Eastern Cooperative Oncology Group performance status of 0 or 1.

You may not qualify if:

• Subject who previously received leukocyte immunoglobulin-like receptor subfamily B (LILRB) or immunoglobulin-like transcript \[ILT\]) targeting agents including those targeting LILRB1 (ILT2), LILRB2 (ILT4), LILRB4 (ILT3), or leukocyte-associated immunoglobulin-like receptor 1 (LAIR1).
• Subject 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.
• Subject has symptomatic central nervous system (CNS) tumor.
• Requires systemic corticosteroids at a dose of \>10 mg prednisone or the dose equivalent of other systemic corticosteroid.
• History of radiation pneumonitis, non-infectious pneumonitis or interstitial lung disease.
• History of Grade ≥3 immune-related AEs with any prior immunotherapy.
• Subjects with known hypersensitivity to any of the components of the IO-202 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).
• Subjects with New York Heart Association (NYHA) Class III or IV congestive heart failure (CHF) or left ventricular ejection fraction (LVEF) \<40% by 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.
• 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.

Sponsors & Collaborators

• Immune-Onc Therapeutics: lead

Study Sites (10)

USC-Norris Comprehensive Cancer Center (119)

Los Angeles, California, 90033, United States

Location

University of Florida (125)

Gainesville, Florida, 32610-0278, United States

Location

Northwestern University - Feinberg School of Medicine (133)

Chicago, Illinois, 60611, United States

Location

Indiana University (123)

Indianapolis, Indiana, 46202, United States

Location

Tisch Mount Sinai (124)

New York, New York, 10029, United States

Location

Carolina BioOncology (102)

Huntsville, North Carolina, 28078, United States

Location

Sarah Cannon Research Institute/Tennessee Oncology (122)

Nashville, Tennessee, 37203, United States

Location

Mary Crowley Cancer Research (108)

Dallas, Texas, 75251, United States

Location

MD Anderson Cancer Center (101)

Houston, Texas, 77030, United States

Location

NEXT Oncology Virginia (121)

Fairfax, Virginia, 22031, United States

Location

Study Officials

• Roya Nawabi, MBA

  Immune-Onc Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2022
• First Posted: April 4, 2022
• Study Start: April 11, 2022
• Primary Completion: March 29, 2024
• Study Completion: May 31, 2024
• Last Updated: June 4, 2024

Record last verified: 2023-10

Locations

US (10)