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A Phase 1, First-in-human Study of OKN4395 and Pembrolizumab in Patients With Solid Tumors

The purpose of this study is to investigate the study drug, OKN4395, administered alone and in combination with pembrolizumab.

The overall objectives of this study are to determine the safety and tolerability (degree to which side effects of a drug can be tolerated) of OKN4395 alone and in combination with pembrolizumab, OKN4395 and metabolites (broken-down substances) of OKN4395 levels in the blood, and antitumor activity of OKN4395 alone and in combination with pembrolizumab.

This study will be split into 2 parts. Part 1a will look at multiple doses of OKN4395 either alone (monotherapy) or with pembrolizumab (combination therapy) administered on day 1 of each 21-day cycle in patients with solid tumors until the participant has disease progression or discontinues for any reason. The dose of OKN4395 will be increased, after each group of 3 or more participants completes their first 3 weeks of treatment and their data is evaluated for safety, with a planned dose range from 10 mg twice a day to 450 mg twice a day through 13 dose levels. Part 1a also includes a parallel substudy (Substudy 1) consisting of at least 12 participants, aiming to test the effect of food and stomach acid on the levels of OKN4395 in the blood as well as its tolerability.

Part 1b will evaluate OKN4395 alone and in combination with pembrolizumab administered on day 1 of each 21-day cycle in patients with selected cancer types. Part 1b will comprise 4 cohorts: Cohort 1 in sarcoma (OKN4395 alone), Cohort 2 in non-small cell lung cancer (NSCLC), Cohort 3 in colorectal cancer, and Cohort 4 in gastric cancer (GC), with cohorts 2 to 4 in combination with pembrolizumab.

The overall study will enrol approximately 146 participants with up to 54 participants to receive OKN4395 alone and 12 participants to receive OKN4395 in combination with pembrolizumab in Part 1a, and 80 participants in Part 1b split: 20 on monotherapy and 60 on combination therapy.

The study will be conducted in the US, Australia, UK and in the EU.

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Detailed Description

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Call 1800-9860-568 now to find out if you are eligible.

Age icon
Age
18 - None
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Gender
All
NCT ID icon
NCT ID
NCT06789172
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Phase
1
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Status
Recruiting Now
Medical Condition icon
Medical Condition
Gastric Cancer

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Medical Condition
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The Study
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About Clinical Trials
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Your Journey

01
Receiving the medication
You would receive etanercept (Enbrel) twice a week for 12 weeks and then once a week for 12 weeks. Etanercept, as well as study related medical care, is provided at no cost.
02
Visiting the study site
Study participation involves approximately 8 visits to your local study center over 6 to 7 months.
03
Follow-up
There would also be a follow-up telephone call 30days after completing the study. No visits are required after participation is complete.

Call 1800-9860-568 now to find out if you are eligible.