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A Phase 1, First-in-human Study of OKN4395 and Pembrolizumab in Patients With Solid Tumors
NCT06789172 · View on ClinicalTrials.gov ↗
Study Summary
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 patients 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 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 5 cohorts: Cohort 1 in sarcoma (OKN4395 alone), Cohort 2 pancreatic adenocarcinoma (OKN4395 alone), Cohort 3 in non-small cell lung cancer (NSCLC), Cohort 4 in colorectal cancer, and Cohort 5 in head \& neck squamous cell carcinoma (HNSCC), with cohorts 3 to 5 in combination with pembrolizumab. The monotherapy expansion Cohort 1 will also be used to explore the effect of food on the levels of OKN4395 in the blood. Similarly, Cohort 2 will be used to explore the effect of gastric pH on the levels of OKN4395 in the blood. The overall study will enrol approximately 166 participants with up to 54 participants to receive OKN4395 alone and 12 participants to receive OKN4395 in combination with pembrolizumab in Part 1a, and 100 participants in Part 1b split: 40 on mon
Conditions Studied
Interventions
- OTHER Fasting
- COMBINATION_PRODUCT Pembrolizumab
- DRUG H2 Receptor Antagonist
- DRUG OKN4395
- OTHER Fed
Study Locations (10)
Other
- The Beatson — Glasgow
- Leicester Royal Infirmary — Leicester
- University College London Hospital — London
- The Christie — Manchester
- Churchill Hospital — Oxford
California
- Precision NextGen Oncology and Research Center — Beverly Hills
- Sarcoma Oncology Center — Santa Monica
Texas
- MD Anderson Cancer Center — Houston
New South Wales
- Chris O'Brien Lifehouse — Sydney
Western Australia
- Linear Clinical Research — Perth
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 166 participants |
| Start Date | 2025-01-23 |
| Est. Completion | 2028-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06789172
The ClinicalTrials.gov registry entry for NCT06789172 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 166 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Epkin, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 10 conditions, with Non Small Cell Lung Cancer appearing as the primary indexed condition, and to 5 interventions — of which Fasting is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06789172 reports 10 study locations spanning 5 distinct geographic areas — top geographies include Other, California, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06789172 about?
NCT06789172 is a clinical study titled "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 combinat...
What is the current status of trial NCT06789172?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 166 participants. The study started on 2025-01-23. Estimated completion is 2028-09.
What conditions does trial NCT06789172 study?
This clinical trial studies the following conditions: Non Small Cell Lung Cancer, Sarcoma, Head and Neck Squamous Cell Carcinoma, NSCLC, Pancreatic Adenocarcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06789172?
The interventions under investigation include: Fasting (OTHER), Pembrolizumab (COMBINATION_PRODUCT), H2 Receptor Antagonist (DRUG), OKN4395 (DRUG), Fed (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06789172?
This trial is sponsored by Epkin, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06789172 being conducted?
This trial has 10 study locations across California, Texas, New South Wales, Western Australia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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