IO-108 + PD-1 Inhibitors for Advanced Cancer

Recruiting in Palo Alto (17 mi)

+30 other locations

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Immune-Onc Therapeutics Inc

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

Adults with advanced solid tumors that have not responded to, or cannot receive standard treatments may join this trial. They should be in relatively good health (ECOG status 0-1), have measurable disease, and proper liver and kidney function. Exclusions include serious lung conditions, symptomatic brain tumor spread, severe immune reactions from past immunotherapies, uncontrolled infections including hepatitis B/C and HIV, certain heart issues within the last 6 months, or recent other cancer therapies.

Inclusion Criteria

I am 18 years old or older.

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

I am 18 years old or older.

I can carry out all my usual activities without help.

Exclusion Criteria

I have previously received a specific antibody therapy for my condition.

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

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

My cancer has spread to my brain and is causing symptoms.

I have had severe side effects from previous immunotherapy.

I do not have any ongoing, untreated infections.

I do not have serious heart rhythm problems.

I do not have any active infections like HBV, HCV, HIV, COVID-19, or AIDS.

Participant Groups

The study is testing IO-108 alone or combined with PD-1 inhibitors pembrolizumab or cemiplimab in patients with various advanced solid tumors. It aims to determine the safety profile of IO-108, how well it's tolerated by patients when used alone or alongside established immunotherapies and to find an effective dose for future studies.

3Treatment groups

Experimental Treatment

Group I: IO-108 MonotherapyExperimental Treatment1 Intervention

Treatment of patients with advanced solid tumors with IO-108 monotherapy

Group II: IO-108 + pembrolizumab combination therapyExperimental Treatment1 Intervention

Treatment of patients with advanced solid tumors with IO-108 in combination with a fixed dose of pembrolizumab

Group III: IO-108 + cemiplimab combination therapyExperimental Treatment1 Intervention

Treatment of patients with advanced solid tumors with IO-108 in combination with a fixed dose of cemiplimab