What side effects are associated with this type of intervention?

Treatments for solid tumors involving immune modulation and PD-1 inhibition, such as pembrolizumab, commonly cause immune-related adverse events (irAEs). These include fatigue, rash, and diarrhea, with more severe effects potentially impacting the lungs (pneumonitis), intestines (colitis), liver (hepatitis), endocrine glands (thyroiditis, adrenal insufficiency), and kidneys (nephritis). Management often requires immunosuppressive therapies like corticosteroids. Combination therapies may increase the risk and severity of these side effects.

What prior FDA approvals exist?

The FDA has approved several immune modulation and PD-1 inhibition therapies for the treatment of solid tumors. Pembrolizumab, a PD-1 inhibitor, has been approved for various cancers, including melanoma, non-small cell lung cancer (NSCLC), and renal cell carcinoma. Nivolumab, another PD-1 inhibitor, is also approved for similar indications. Additionally, ipilimumab, a CTLA-4 inhibitor, has been approved for melanoma and is often used in combination with nivolumab. These approvals highlight the effectiveness of immune checkpoint inhibitors in treating solid tumors.

What other types of research exist?

Promising alternatives to IO-202 and Pembrolizumab for solid tumors include: 1) Nivolumab (PD-1 inhibitor) combined with Ipilimumab (CTLA-4 inhibitor), which has shown efficacy in various solid tumors. 2) Atezolizumab (PD-L1 inhibitor) combined with Bevacizumab (VEGF inhibitor), particularly for renal cell carcinoma and urothelial carcinoma. 3) Enfortumab Vedotin, an antibody-drug conjugate targeting Nectin-4, for urothelial carcinoma. 4) Sacituzumab Govitecan, an antibody-drug conjugate targeting Trop-2, for metastatic urothelial carcinoma.

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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

Subject must have an Eastern Cooperative Oncology Group performance status of 0 or 1

Must not have

Requires systemic corticosteroids at a dose of >10 mg prednisone or the dose equivalent of other systemic corticosteroid

Subject has symptomatic central nervous system (CNS) tumor

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

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial is testing a new drug called IO-202, alone or with another drug, in adults with advanced cancers that have returned or don't respond to other treatments. The goal is to see if IO-202 is safe and effective.

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.

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.

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 am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I need more than 10 mg of prednisone or its equivalent daily.

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I have symptoms from a brain tumor.

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I have had severe side effects from previous immunotherapy.

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I do not have any active infections, including HBV, HCV, HIV, SARS-COV-2, or AIDS.

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I have had lung inflammation or scarring not caused by an infection.

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I do not have serious heart rhythm problems.

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I have not been treated with drugs targeting LILRB or ILT.

Timeline

Screening ~ 3 weeks3 visits

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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 study objectives

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

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

FDA approved

IO-202

2022

Completed Phase 1

~30

Pembrolizumab

FDA approved

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for solid tumors include immune modulation and PD-1 inhibition. Immune modulation, such as with IO-202, works by enhancing the body's immune response against cancer cells, making it easier for the immune system to identify and destroy these cells. PD-1 inhibitors like pembrolizumab block the programmed cell death protein 1 (PD-1) pathway, which tumors often exploit to evade immune detection. By inhibiting this pathway, pembrolizumab reactivates T-cells, allowing them to attack cancer cells more effectively. These treatments are crucial for solid tumor patients as they offer a targeted approach to boost the immune system's ability to fight cancer, potentially leading to better outcomes and prolonged survival.

Recurrent glioma clinical trial, CheckMate-143: the game is not over yet.