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 (Sep 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 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Other
Cancer type
Sarcoma
Head and Neck Squamous Cell Carcinoma
Non-Small Cell Lung Carcinoma
Colorectal Cancer
Gastric Cancer
Esophageal Carcinoma
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)
Required: HER2 (ERBB2) wild-type
GC (gastric and gastro-esophageal junction adenocarcinoma), HER2-negative
Required: Mismatch-repair proficient (pMMR / MSS)
CRC (Microsatellite stable or Microsatellite instability - low)
Performance status
ECOG 0–1(Restricted strenuous activity)
Lab requirements
Blood counts
absolute neutrophil counts ≥1.5 × 10^9 /L, platelet counts ≥75 × 10^9 /L, and hemoglobin ≥8 g/dL
Kidney function
creatinine clearance ≥ 60 mL/min1 by Du Bois & Du Bois formula
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)
Adequate hematologic, renal, and hepatic function (based on local laboratory assessments): 1. Hematological variables: absolute neutrophil counts ≥1.5 × 10^9 /L, platelet counts ≥75 × 10^9 /L, and hemoglobin ≥8 g/dL 2. Renal variables: creatinine clearance ≥ 60 mL/min1 by Du Bois & Du Bois formula 3. Hepatic variables: 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) 4. Serum albumin ≥30 g/L
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 →Frequently asked questions
Is NCT06789172 currently recruiting?
Yes, this trial is currently recruiting patients.
Does this trial require EGFR?
Yes, EGFR wild-type is a required biomarker for enrollment.
Does this trial require ALK?
Yes, ALK wild-type is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 wild-type is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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