Actively Recruiting
A Phase 1, Open-label, Dose-escalation and Cohort Expansion Study of OKN4395 Alone and With Pembrolizumab in Advanced Solid Tumors
Led by Epkin · Updated on 2026-05-22
166
Participants Needed
10
Research Sites
8 weeks
Total Duration
On this page
Sponsors
E
Epkin
Lead Sponsor
P
Precision For Medicine
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the study drug OKN4395 alone and in combination with pembrolizumab in patients with advanced solid tumors. The study aims to assess the safety, tolerability, blood levels of OKN4395 and its metabolites, and the antitumor activity of these treatments. This phase 1 study focuses on patients whose tumors involve a COX2-associated immunosuppressive pathway and includes various cancer types such as sarcoma, pancreatic adenocarcinoma, non-small cell lung cancer, colorectal cancer, and head and neck squamous cell carcinoma. The study consists of two parts. Part 1a involves dose escalation of OKN4395 alone or with pembrolizumab given on day 1 of each 21-day cycle to determine the optimal dose, with doses ranging from 10 mg twice daily up to 450 mg twice daily. Part 1b includes five cohorts with specific cancer types receiving OKN4395 alone or combined with pembrolizumab to evaluate treatment effects and explore factors like food and gastric pH on OKN4395 blood levels. Participants continue treatment until disease progression or for other reasons. Participants will undergo safety and response assessments including monitoring of dose-limiting toxicities, treatment-emergent adverse events, laboratory tests, ECGs, and vital signs over up to 27 months in Part 1a and up to 12 months in Part 1b. Researchers will also evaluate overall response rates, disease control, progression-free survival, and pharmacokinetics of OKN4395. The study involves multiple visits for treatment and evaluations, with careful observation of side effects and tumor responses throughout the trial period.
CONDITIONS
Brief Title
A Phase 1, First-in-human Study of OKN4395 and Pembrolizumab in Patients With Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Histologically or cytologically confirmed locally advanced or metastatic solid tumors with a COX2-associated immunosuppressive pathway
- For Phase 1a: solid tumors without effective standard treatments or when standard treatments are no longer effective, refused, or not tolerated
- For Phase 1b: specific cancer types (sarcoma, pancreatic adenocarcinoma, NSCLC, colorectal cancer, HNSCC) with exhausted appropriate authorized treatment options
- ECOG performance status of 0 or 1
- Recovery from any relevant adverse events from previous treatments
- Presence of one or more new or growing tumor lesions suitable for biopsy
- At least one measurable target lesion by RECIST 1.1
- Ability to swallow and retain OKN4395 orally without significant gastrointestinal issues
- Willingness and ability to comply with food or gastric pH effect evaluations as required
- Adequate blood counts, kidney and liver function according to specified laboratory values
You will not qualify if you...
- Recent anticancer therapy within specified timeframes before first study drug dose (e.g., chemotherapy within 21 days, immunotherapy within 28 days, radiation within 7 to 14 days depending on type)
- Progressive or symptomatic central nervous system metastases requiring immunosuppressive therapies
- Active infections requiring intravenous treatment
- Unstable chronic obstructive pulmonary disease
- Known active hepatitis B, hepatitis C, or HIV infection without viral suppression
- History of bleeding disorders or recent gastrointestinal bleeding
- Untreated Helicobacter pylori infection
- Recent use of drugs affecting gastrointestinal pH or systemic steroids
- Active autoimmune disease requiring systemic treatment in past 2 years for combination therapy participants
- Recent use of NSAIDs, COX2 inhibitors, or synthetic prostaglandins beyond allowed limits
- Use of strong enzyme inhibitors or inducers within 14 days
- QTcF interval over 450 ms
- Known allergies to OKN4395 or pembrolizumab components
- Pregnant or breastfeeding women
- Other medical or surgical conditions that may interfere with study participation or safety as judged by the physician
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 27 months or until dose-limiting toxicity or discontinuation
Participants receive oral OKN4395 twice daily, alone or in combination with pembrolizumab given intravenously every 3 weeks. Some participants may fast or eat before the first OKN4395 dose, and some may receive a medication to reduce stomach acid before dosing as part of different cohorts.
Regular visits for dosing and safety assessments throughout treatment
Duration - Up to 12 months after last participant enrollment in Phase 1b
Participants are monitored for safety and treatment effects after the end of treatment, including assessment of side effects, tumor response, and survival.
Periodic visits for assessments during follow-up
Trial Site Locations
Total: 10 locations
1
Precision NextGen Oncology and Research Center
Beverly Hills, California, United States, 90212
Actively Recruiting
2
Sarcoma Oncology Center
Santa Monica, California, United States, 90403
Actively Recruiting
3
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
4
Chris O'Brien Lifehouse
Sydney, New South Wales, Australia
Actively Recruiting
5
Linear Clinical Research
Perth, Western Australia, Australia, 6009
Actively Recruiting
6
The Beatson
Glasgow, United Kingdom
Actively Recruiting
7
Leicester Royal Infirmary
Leicester, United Kingdom, LE1 5WW
Actively Recruiting
8
University College London Hospital
London, United Kingdom
Actively Recruiting
9
The Christie
Manchester, United Kingdom
Actively Recruiting
10
Churchill Hospital
Oxford, United Kingdom
Actively Recruiting
Research Team
E
Epkin
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
9
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