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Solid Tumor, AdultPhase 1NCT05054348

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

A Phase 1 study testing IO-108, IO-108 + pembrolizumab combination therapy and IO-108 + cemiplimab combination therapy in people with Solid Tumor, Adult, run by Immune-Onc Therapeutics at 24 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumor, Adult
What is being tested?
IO-108, IO-108 + pembrolizumab combination therapy and IO-108 + cemiplimab combination therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
91 participants
Where
24 sitesUnited States
Study dates
30 Sep 2021to 31 May 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 17Show fewer
  • 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.

Trial locations and contacts

24 sites in 1 country.

24 sites in 1 country

United States24 sites

  • Texas Oncology - Austin (142) (USOR SITE)

    Austin, Texas, 78705

  • Beverly HIlls Cancer Center (129)

    Beverly Hills, California, 90211

  • St. Vincent - Frontier Cancer Center (135)

    Billings, Montana, 59102

  • Gabrail Cancer Center (128)

    Canton, Ohio, 44718

  • Oncology Hematology Care Clinical Trials, LLC (144) (USOR SITE)

    Cincinnati, Ohio, 45242

  • Maryland Oncology Hematology, PA (145) (USOR SITE)

    Columbia, Maryland, 21044

  • Texas Oncology - Baylor Charles A. (143) (USOR SITE)

    Dallas, Texas, 75246

  • Karmanos Cancer Institute (126)

    Detroit, Michigan, 48201

  • NEXT Oncology-Virginia (121)

    Fairfax, Virginia, 22031

  • University of Florida (125)

    Gainesville, Florida, 32611

  • MD Anderson Cancer Center (101)

    Houston, Texas, 77030

  • Oncology Consultants, P.A. (138)

    Houston, Texas, 77030

  • Carolina BioOncology (102)

    Huntsville, North Carolina, 28078

  • Indiana University Melvin and Bren Simon Comprehensive Cancer Center (123)

    Indianapolis, Indiana, 46202

  • Florida Cancer Specialists (134)

    Lake Mary, Florida, 32746

  • Rocky Mountain Cancer Centers, LLP (141) (USOR SITE)

    Lone Tree, Colorado, 80124

  • NYU Langone Health (131)

    New York, New York, 10016

  • Memorial Cancer Institute (146)

    Pembroke Pines, Florida, 33021

  • UPMC Hillman Cancer Center (105)

    Pittsburgh, Pennsylvania, 15209

  • Providence Cancer Institute (104)

    Portland, Oregon, 97213

  • Florida Cancer Specialists & Research Institute (103)

    Sarasota, Florida, 34232

  • Swedish Cancer Institute (147)

    Seattle, Washington, 98104

  • Hematology Oncology (136)

    Stuart, Florida, 34952

  • Arizona Oncology Associates, PC-HOPE (140) (USOR SITE)

    Tucson, Arizona, 85711

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
IO-108, IO-108 + pembrolizumab combination therapy, IO-108 + cemiplimab combination therapy
Keywords
IO-108

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IO-108Biological

    IO-108 given as monotherapy

  • IO-108 + pembrolizumab combination therapyBiological

    Also called IO-108 + Keytruda combination therapy

    IO-108 and fixed dose pembrolizumab combination therapy

  • IO-108 + cemiplimab combination therapyBiological

    Also called IO-108 + Libtayo combination therapy

    IO-108 and fixed dose cemiplimab combination therapy

Study groups in NCT05054348
Study groupRoleWhat they receive
IO-108 MonotherapyExperimentalTreatment of patients with advanced solid tumors with IO-108 monotherapy
Receives: Biological: IO-108
IO-108 + pembrolizumab combination therapyExperimentalTreatment of patients with advanced solid tumors with IO-108 in combination with a fixed dose of pembrolizumab
Receives: Biological: IO-108 + pembrolizumab combination therapy
IO-108 + cemiplimab combination therapyExperimentalTreatment of patients with advanced solid tumors with IO-108 in combination with a fixed dose of cemiplimab
Receives: Biological: IO-108 + cemiplimab combination therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 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

  2. 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

    Measured: From the first dose of IO-108 until 21 days post-treatment

  3. 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

    Measured: 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 outcomes (5)

  1. Maximum plasma concentration (Cmax) of IO-108

    Characterize the Cmax of IO-108 by successive sampling of blood at pre-specified time points

    Measured: From the first dose of IO-108 until day 15 post-treatment

  2. Steady state concentration of IO-108

    Characterize steady state concentration of IO-108 by successive sampling of blood at pre-specified time points

    Measured: From the second dose of IO-108 until the last treatment which is up to 2 years from the first treatment date

  3. 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)

    Measured: From the first dose until 30 days after the last treatment

  4. Anti-tumor activity of IO-108 and IO-108+pembrolizumab

    Determine preliminary rates of response after treatment with IO-108

    Measured: 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

  5. 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

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Sep 2021
  2. Study start30 Sep 2021
  3. Primary completion29 Apr 2024
  4. Study completion31 May 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Dose escalation, dose expansion and dose randomization
Masking
None (open label)
Enrolment
91 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05054348
Sponsor's protocol ID
IO-108-CL-001
Status last verified
Mar 2024
First submitted
30 Aug 2021
Last updated
4 Jun 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Taylor MH, Naing A, Powderly J, Woodard P, Chung L, Lin WH, Tian H, Siemers N, Xiang H, Deng R, Hong K, Valencia D, Huang T, Zhu Y, Liao XC, Schebye XM, Patel MR. Phase I dose escalation study of IO-108, an anti-LILRB2 antibody, in patients with advanced solid tumors. J Immunother Cancer. 2024 Nov 20;12(11):e010006. doi: 10.1136/jitc-2024-010006.

    PubMed 39567210

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing IO-108, IO-108 + pembrolizumab combination therapy and IO-108 + cemiplimab combination therapy in people with Solid Tumor, Adult, run by Immune-Onc Therapeutics at 24 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05054348, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2024.

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