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Monoclonal Antibodies

IO-202 + Pembrolizumab for Solid Tumors

Phase 1
Waitlist Available
Research Sponsored by Immune-Onc Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject must be ≥18 years old
Part 2 - Dose Expansion: Subject must have failed at least one available therapy for the disease under study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the first dose of io-202 io-202 and io-202 + pembrolizumab up to 2 years from the first treatment.
Awards & highlights

Study Summary

This trial is testing a new drug, IO-202, to see if it is safe and effective in treating patients with advanced solid tumors. The trial will also help determine the recommended dose of IO-202 for future trials.

Who is the study for?
Adults with advanced solid tumors who have tried or can't tolerate standard treatments. They must have measurable disease, be in good physical condition (ECOG status of 0 or 1), and not have had certain heart issues, severe immune reactions to past immunotherapies, active infections like hepatitis or HIV, or other serious health problems that could affect study participation.Check my eligibility
What is being tested?
The trial is testing different doses of IO-202 alone and combined with pembrolizumab to find the safest and most effective dose for treating various solid tumors. The first part increases doses to find the best one; the second part expands on this dose in more patients.See study design
What are the potential side effects?
Possible side effects include typical immune therapy-related issues such as inflammation in organs, infusion reactions, fatigue, allergic responses specific to drug components, blood disorders, increased infection risk and potential exacerbation of underlying conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have tried at least one treatment for my condition without success.
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I have an advanced cancer and cannot take standard treatments.
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I am fully active or restricted in physically strenuous activity but can do light work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the first dose of io-202 io-202 and io-202 + pembrolizumab up to 2 years from the first treatment.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from the first dose of io-202 io-202 and io-202 + pembrolizumab up to 2 years from the first treatment. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose-limiting toxicities (DLTs) with IO-202 and IO-202 + pembrolizumab
Incidence of treatment-emergent and serious adverse events in patients treated with IO-202 and IO-202 + pembrolizumab
Study discontinuations due to adverse events (AEs)
Secondary outcome measures
Anti-tumor activity of IO-202 and IO-202 + pembrolizumab
Immunogenicity of IO-202 and IO-202 + pembrolizumab
Maximum serum concentration (Cmax) of IO-202
+1 more
Other outcome measures
Receptor occupancy in IO-202 monotherapy and IO-202 + pembrolizumab

Trial Design

3Treatment groups
Experimental Treatment
Group I: IO-202 dose escalation + pembrolizumabExperimental Treatment1 Intervention
Increasing dose levels of IO-202 with fixed dose of pembrolizumab
Group II: IO-202 Monotherapy (dose escalation)Experimental Treatment2 Interventions
Experimental: IO-202 dose escalation + pembrolizumab increasing dose levels of IO-202 with fixed dose of pembrolizumab
Group III: IO-202 + pembrolizumab combination therapy (dose expansion)Experimental Treatment1 Intervention
RP2D + pembrolizumab combination therapy in solid tumor cohorts

Find a Location

Who is running the clinical trial?

Immune-Onc TherapeuticsLead Sponsor
3 Previous Clinical Trials
504 Total Patients Enrolled
Immune-Onc Therapeutics IncLead Sponsor
2 Previous Clinical Trials
415 Total Patients Enrolled
Sydney RayStudy DirectorImmune-Onc Therapeutics

Media Library

IO-202 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05309187 — Phase 1
Solid Tumors Research Study Groups: IO-202 Monotherapy (dose escalation), IO-202 + pembrolizumab combination therapy (dose expansion), IO-202 dose escalation + pembrolizumab
Solid Tumors Clinical Trial 2023: IO-202 Highlights & Side Effects. Trial Name: NCT05309187 — Phase 1
IO-202 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05309187 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What have the reported risks been concerning IO-202?

"There is minimal clinical evidence backing the safety of IO-202, thus it earned a score of 1."

Answered by AI

Is this exploration still available for participation?

"Clinicaltrials.gov indicates that this trial is not currently accepting applicants, despite initially being posted on April 1st 2022 and edited as recently as March 25th 2022. Although the study is inactive at present, there are a plethora of other trials actively recruiting participants right now."

Answered by AI

Are there several sites in the US that are currently administering this experiment?

"This clinical investigation is currently enrolling patients across 4 distinct medical sites. These include Houston, LA and Nashville as well as a few other facilities. To minimize travel pressure during the course of this trial, it's best to select the closest center for your convenience."

Answered by AI

What is the primary aim of this medical experiment?

"As reported by the trial sponsor Immune-Onc Therapeutics, this study's primary outcome is assessing dose-limiting toxicities in regards to IO-202 and IO-202 + pembrolizumab over a two year period. Secondary outcomes include characterizing minimum concentration of IO-202 through blood sampling; determining preliminary rates of response after treatment with IO 202; and examining immunogenicity associated with both medications."

Answered by AI
~0 spots leftby Apr 2024