OncoMatch/Clinical Trials/NCT06789172
A Phase 1, First-in-human Study of OKN4395 and Pembrolizumab in Patients With Solid Tumors
Is NCT06789172 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including OKN4395 and Pembrolizumab for solid tumours.
Treatment: OKN4395 · Pembrolizumab · H2 Receptor Antagonist — 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 monotherapy and 60 on combination therapy. The study will be conducted in the US, Australia, UK and in the EU.
Check if I qualifyExtracted eligibility criteria
Cancer type
Sarcoma
Head and Neck Squamous Cell Carcinoma
Small Cell Lung Cancer
Non-Small Cell Lung Carcinoma
Pancreatic Cancer
Colorectal Cancer
Biomarker criteria
Required: EGFR wild-type
NSCLC (squamous or adenomatous without EGFR/ALK mutations)
Required: ALK wild-type
NSCLC (squamous or adenomatous without EGFR/ALK mutations)
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: platinum-based chemotherapy — NSCLC
previous platinum-based chemotherapy
Must have received: anti-PD-1/PD-L1 therapy — NSCLC, HNSCC
previous PD-(L)1 CPI regimen (unless not eligible/unwilling to receive such therapies)
Cannot have received: chemotherapy
Chemotherapy, ADCs, or other antibodies < 21 days
Cannot have received: immunotherapy or cellular therapy
Immunotherapy or cellular therapy < 28 days
Cannot have received: radiation therapy
Radiation therapy (palliative radiation for bone pain <48 hours; stereotactic or small field brain irradiation <7 days; all other radiation therapy <14 days)
Cannot have received: tyrosine kinase inhibitor
TKI or any other anticancer therapy < 5 half-lives or < 7 days, whichever is longer
Cannot have received: NSAIDs, COX2 inhibitors, synthetic prostaglandins
Exception: acetylsalicylic acid ≤ 160 mg/day, or 325 mg ≤ 3 times/week is permitted
Systemic treatment with NSAIDs, COX2 inhibitors, or synthetic prostaglandins within 5 half-lives prior to the first dose of OKN4395
Cannot have received: strong inhibitors/inducers of CYP and UGT enzymes
Systemic treatment with strong inhibitors/inducers of CYP and UGT enzymes within 14 days of first dose of OKN4395
Lab requirements
Blood counts
absolute neutrophil counts ≥1.5 × 109 /l, platelet counts ≥75 × 109 /l, and hemoglobin ≥8 g/dl
Kidney function
creatinine clearance ≥ 60 ml/min
Liver function
total serum bilirubin ≤1.5 × uln, ast and alt ≤3 × uln, and alp ≤2.5 × uln; except for hyperbilirubinemia of gilbert's syndrome (participants with gilbert's syndrome can be included if total serum bilirubin ≤5× uln and direct bilirubin ≤1.5 x uln)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Precision NextGen Oncology and Research Center · Beverly Hills, California
- Sarcoma Oncology Center · Santa Monica, California
- MD Anderson Cancer Center · Houston, Texas
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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