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New treatment option for Solid Tumours
Official title A Phase 1, First-in-human Study of OKN4395 and Pembrolizumab in Patients With Solid Tumors
ClinicalTrials.gov ID: NCT06789172
What this study is testing
What is OKN4395?
OKN4395 is an investigational medicine, given as a twice-daily pill taken by mouth, being studied as a potential treatment for solid tumours.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histologically or cytologically confirmed disease, locally advanced or metastatic: For Phase 1a: Solid tumor with a COX2-associated immunosuppressive...
- Cohort 1: Sarcoma (fibrous sarcoma [myxofibrosarcoma or solitary fibrous tumor], dedifferentiated liposarcoma, undifferentiated pleomorphic sarcoma...
- Cohort 2: NSCLC (squamous or adenomatous without EGFR/ALK mutations), with disease progression on a PD-(L)1 CPI regimen, and no more than 3 prior...
- Cohort 3: CRC (Microsatellite stable or Microsatellite instability - low), and no more than 4 prior lines of systemic therapy.
- Cohort 4: GC (gastric and gastro-esophageal junction adenocarcinoma), HER2-negative, planned to or currently receiving CPI monotherapy as maintenance...
You likely can't join if
- Except for the current regimen in Cohort 4, ongoing or recent anticancer therapy within the following timeframe prior to first dose of study drug:
- Chemotherapy, ADCs, or other antibodies \< 21 days
- Immunotherapy or cellular therapy \< 28 days
- Radiation therapy (palliative radiation for bone pain \<48 hours; stereotactic or small field brain irradiation \<7 days; all other radiation therapy...
- TKI or any other anticancer therapy \< 5 half-lives or \< 7 days, whichever is longer
- Central nervous system metastasis (radiologically progressive, or clinically symptomatic, or requiring immunosuppressive therapies [including low...
See the full eligibility criteria
Who can join
- Histologically or cytologically confirmed disease, locally advanced or metastatic: For Phase 1a: Solid tumor with a COX2-associated immunosuppressive pathway, for which standard treatment options are not available, no...
- Cohort 1: Sarcoma (fibrous sarcoma [myxofibrosarcoma or solitary fibrous tumor], dedifferentiated liposarcoma, undifferentiated pleomorphic sarcoma or pleomorphic sarcoma, or leiomyosarcoma), that is either refractory...
- Cohort 2: NSCLC (squamous or adenomatous without EGFR/ALK mutations), with disease progression on a PD-(L)1 CPI regimen, and no more than 3 prior lines of systemic therapy. When known, PD-L1 status should be provided.
- Cohort 3: CRC (Microsatellite stable or Microsatellite instability - low), and no more than 4 prior lines of systemic therapy.
- Cohort 4: GC (gastric and gastro-esophageal junction adenocarcinoma), HER2-negative, planned to or currently receiving CPI monotherapy as maintenance of a first-line CPI + chemotherapy regimen, after chemotherapy...
- ECOG performance status of 0 or 1.
- Recovery from any medically relevant AE/irAE from previous treatment regimen (defined as recovery to Grade ≤1 level per CTCAE v 5.0 before Screening, or chronic, stable, Grade 2 AEs [not worsened to Grade \>2 for \>3...
- One or more new or growing tumor lesions amenable to a safe biopsy (at baseline, a suitable archival specimen obtained when not undergoing treatment and within 1 year [Phase 1a], or within 90 days and after the last...
- At least one target lesion measurable by RECIST 1.1 as noted by local investigators/radiologists.
- The ability to swallow and retain OKN4395 as an oral medication without significant gastrointestinal abnormalities that might alter absorption.
- The willingness and ability to comply with the evaluation, randomizations and requirements of the protocol. For Substudy 1, the ability to comply with the evaluation requirements includes the absence of any condition...
- Adequate hematologic, renal, and hepatic function (based on local laboratory assessments):
- Hematological variables: absolute neutrophil counts ≥1.5 × 109 /L, platelet counts ≥75 × 109 /L, and hemoglobin ≥8 g/dL
- Renal variables: creatinine clearance ≥ 60 mL/min1 by Du Bois \& Du Bois formula
- 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...
- Serum albumin ≥30 g/L
What rules you out
- Except for the current regimen in Cohort 4, ongoing or recent anticancer therapy within the following timeframe prior to first dose of study drug:
- Chemotherapy, ADCs, or other antibodies \< 21 days
- Immunotherapy or cellular therapy \< 28 days
- Radiation therapy (palliative radiation for bone pain \<48 hours; stereotactic or small field brain irradiation \<7 days; all other radiation therapy \<14 days)
- TKI or any other anticancer therapy \< 5 half-lives or \< 7 days, whichever is longer
- Central nervous system metastasis (radiologically progressive, or clinically symptomatic, or requiring immunosuppressive therapies [including low dose steroids]).
- Any active infection (bacterial, viral, fungal) requiring IV systemic therapy.
- Unstable COPD defined as frequent or severe exacerbations per investigator discretion.
- Known history of or active HBV (HBsAg reactive and/or HBV DNA detected) or HCV (HCV RNA detected) infection.
- HIV infection with CD4 lymphocyte count \<350 cells/μL at time of Screening, or failure to achieve and maintain virologic suppression defined as confirmed HIV RNA level \< 50 or lower limit of detection by the local...
- Known history of bleeding disorders, INR ≥1.5 × ULN at screening (or INR and/or aPTT within therapeutic range if on anticoagulation therapy), or a history of gastrointestinal bleeding (inflammatory, ulcerative, or...
- Known H. pylori infection without proof of eradication at least 2 months prior to screening.
- Systemic treatment with any drug known to impact gastrointestinal pH within 7 days (PPIs) or 12 hours (H2 antagonists) of first dose of OKN4395 (unless adapted after Substudy 1). Where said treatments have been used for...
- Acute treatment with any systemic steroid therapy (\>10 mg prednisone equivalent), or any corticosteroid medication within 14 days of first dose of OKN4395 for any condition.
- For participants planned to receive combination therapy: Ongoing and history of active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents...
- Systemic treatment with NSAIDs, COX2 inhibitors, or synthetic prostaglandins within 5 half-lives prior to the first dose of OKN4395 (acetylsalicylic acid ≤ 160 mg/day, or 325 mg ≤ 3 times/week is permitted).
- Systemic treatment with strong inhibitors/inducers of CYP and UGT enzymes within 14 days of first dose of OKN4395.
- QTcF interval of \> 450 ms based on mean of the central triplicate readings.
- Known hypersensitivity to any excipients of the OKN4395 formulation or pembrolizumab (for combination cohorts).
- Pregnant or lactating women. Women of childbearing potential must have a negative serum pregnancy test at screening and have a negative a urine dipstick pregnancy test prior to the initiation of study treatment (can be...
- Evidence of any other active malignancy requiring systemic therapy within the 2 years prior to Screening. (Exceptions: non-melanoma skin cancer, in situ melanoma, in situ cervical cancer, ductal carcinoma in situ of the...
- History or current evidence of any condition, surgical or medical therapy, or laboratory abnormalities that might confound the results of the study, make study drug administration hazardous, interfere with the...
The study team makes the final eligibility decision.
Where it's taking place
- Beverly Hills, California, United States
- Santa Monica, California, United States
- Houston, Texas, United States
- Sydney, New South Wales, Australia
- Perth, Western Australia, Australia
- Glasgow, United Kingdom
- Leicester, United Kingdom
- London, United Kingdom
- Manchester, United Kingdom
- Oxford, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beverly Hills, California, United States; Santa Monica, California, United States; Houston, Texas, United States; Sydney, New South Wales, Australia; Perth, Western Australia, Australia; Glasgow, United Kingdom and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.