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Solid Tumor, AdultPhase 1NCT05309187

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

A Phase 1 study testing IO-202, IO-202 + pembrolizumab combination therapy and RP2D of IO-202 + pembrolizumab combination therapy in multiple solid tumor types in people with Solid Tumor, Adult, run by Immune-Onc Therapeutics at 10 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

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). 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-202, IO-202 + pembrolizumab combination therapy and RP2D of IO-202 + pembrolizumab combination therapy in multiple solid tumor types
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
10 sitesUnited States
Study dates
11 Apr 2022to 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

  • 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.

Who cannot join

  • 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.
Show all 18Show fewer
  • 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.
  • Subjects with any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the subject before study entry.
  • Subject with current active treatment in another interventional therapeutic clinical study.
  • 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

10 sites in 1 country.

10 sites in 1 country

United States10 sites

  • Northwestern University - Feinberg School of Medicine (133)

    Chicago, Illinois, 60611

  • Mary Crowley Cancer Research (108)

    Dallas, Texas, 75251

  • NEXT Oncology Virginia (121)

    Fairfax, Virginia, 22031

  • University of Florida (125)

    Gainesville, Florida, 32610-0278

  • MD Anderson Cancer Center (101)

    Houston, Texas, 77030

  • Carolina BioOncology (102)

    Huntsville, North Carolina, 28078

  • Indiana University (123)

    Indianapolis, Indiana, 46202

  • USC-Norris Comprehensive Cancer Center (119)

    Los Angeles, California, 90033

  • Sarah Cannon Research Institute/Tennessee Oncology (122)

    Nashville, Tennessee, 37203

  • Tisch Mount Sinai (124)

    New York, New York, 10029

Other trials in United States

About this study

Official title: A Phase 1, Multicenter, Open-Label, Dose-Escalation, and Dose-Expansion Study of IO-202 in Combination With Pembrolizumab in Subjects With Advanced, Relapsed, or Refractory Solid Tumors

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).

Read the detailed description

This is a Phase 1, open-label, multicenter, dose-escalation and dose-expansion study of IO-202 in adult subjects with advanced relapsed or refractory solid tumors to study safety, tolerability, pharmacokinetic, pharmacodynamics and clinical activity of IO-202 as monotherapy or in combination with pembrolizumab and to estimate the maximum tolerated dose (MTD) or maximum administered dose (MAD), and to select the RP2D.

Being tested
IO-202, IO-202 + pembrolizumab combination therapy, RP2D of IO-202 + pembrolizumab combination therapy in multiple solid tumor types
Keywords
IO-202

What participants receive

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

  • IO-202Biological

    IO-202 given as monotherapy

  • IO-202 + pembrolizumab combination therapyBiological

    Also called IO-202 + Keytruda combination therapy

    IO-202 and fixed dose pembrolizumab combination therapy

  • RP2D of IO-202 + pembrolizumab combination therapy in multiple solid tumor typesBiological

    Also called RP2D of IO-202 + Keytruda combination therapy

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

Study groups in NCT05309187
Study groupRoleWhat they receive
IO-202 Monotherapy (dose escalation)ExperimentalNot described
Receives: Biological: IO-202
IO-202 dose escalation + pembrolizumabExperimentalIncreasing dose levels of IO-202 with fixed dose of pembrolizumab
Receives: Biological: IO-202 + pembrolizumab combination therapy
IO-202 + pembrolizumab combination therapy (dose expansion)ExperimentalRP2D + pembrolizumab combination therapy in solid tumor cohorts
Receives: Biological: RP2D of IO-202 + pembrolizumab combination therapy in multiple solid tumor types

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-202 and IO-202 + pembrolizumab

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

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

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

    DLTs as measured by the incidence during Cycle 1.

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

  3. Study discontinuations due to adverse events (AEs)

    The number of study discontinuations due to AEs

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

Secondary outcomes (4)

  1. Maximum serum concentration (Cmax) of IO-202

    Characterize the Cmax of IO-202 by successive sampling of blood at pre-specified times

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

  2. Minimum concentration of IO-202

    Characterize minimum concentration of IO-202 by successive sampling of blood at pre-specified time points

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

  3. Immunogenicity of IO-202 and IO-202 + pembrolizumab

    Determine the incidence/titer of anti-drug antibodies (ADAs) against IO-202 and pembrolizumab (in combination treatment)

    Measured: From the first dose until 24 months after the last treatment

  4. Anti-tumor activity of IO-202 and IO-202 + pembrolizumab

    Determine preliminary rates of response after treatment with IO-202

    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 an estimated period of 24 months

Timeline

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

  1. First posted4 Apr 2022
  2. Study start11 Apr 2022
  3. Primary completion29 Mar 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
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05309187
Sponsor's protocol ID
IO-202-CL-002
Status last verified
Oct 2023
First submitted
25 Mar 2022
Last updated
4 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing IO-202, IO-202 + pembrolizumab combination therapy and RP2D of IO-202 + pembrolizumab combination therapy in multiple solid tumor types in people with Solid Tumor, Adult, run by Immune-Onc Therapeutics at 10 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 18 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 10 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-202 and IO-202 + pembrolizumab (time frame: From first dose of IO-202 until the end of treatment which is up to 2 years from the first treatment date). 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 NCT05309187.

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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