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OKN4395

Phase 1

Solid Tumours | Small molecule | Oncology |Precision BioSciences, Inc.|Last Updated: Sep 5, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment166
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06789172A Phase 1, First-in-human Study of OKN4395 and Pembrolizumab in Patients With Solid TumorsPHASE1 RECRUITING 166 — — Jan 23, 2025Sep 1, 2028Sep 5, 202510 United States, Australia +1
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Study Endpoints
Primary Endpoints
Incidence of DLTs in participants treated with OKN4395 as monotherapy and in combination with pembrolizumab. (Phase 1a)
From enrolment of the first participant until the end of Phase 1a or until the DLT threshold is reached; up to 27 months

DLTs = dose-limiting toxicities

Incidence and severity of TEAEs in participants treated with OKN4395 as a monotherapy and in combination with pembrolizumab in solid tumors. (Phase 1a)
From enrolment of the first participant to the end of Phase 1a; up to 27 months

TEAEs = treatment-emergent adverse events

Incidence and severity of SAEs in participants treated with OKN4395 as a monotherapy and in combination with pembrolizumab in solid tumors. (Phase 1a)
From enrolment of the first participant to the end of Phase 1a; up to 27 months

SAEs = serious adverse events

Incidence of dose interruptions, dose reductions, and dose intensities in participants treated with OKN4395 as a monotherapy and in combination with pembrolizumab in solid tumors. (Phase 1a)
From enrolment of the first participant to the end of Phase 1a; up to 27 months
Incidence and severity of clinically relevant ECG abnormalities in participants treated with OKN4395 as a monotherapy and in combination with pembrolizumab in solid tumors. (Phase 1a)
From enrolment of the first participant to the end of Phase 1a; up to 27 months

ECG = electrocardiogram

Incidence and severity of laboratory abnormalities in participants treated with OKN4395 as a monotherapy and in combination with pembrolizumab in solid tumors. (Phase 1a)
From enrolment of the first participant to the end of Phase 1a; up to 27 months

Graded where appropriate with the CTCAE v5.0.

Incidence and severity of clinically relevant changes in vital signs in participants treated with OKN4395 as a monotherapy and in combination with pembrolizumab in solid tumors. (Phase 1a)
From enrolment of the first participant to the end of Phase 1a; up to 27 months
To assess the overall response rate in participants treated with OKN4395 as monotherapy and in combination with pembrolizumab in selected cancer types. (Phase 1b)
From enrolment of first participant in Phase 1b until 24 weeks after the last participant is enrolled in Phase 1b; up to 12 months from beginning of Phase 1b
Secondary Endpoints
To assess the overall response rate in participants treated with OKN4395 as monotherapy and in combination with pembrolizumab in selected cancer types. (Phase 1a)
From enrolment of the first participant until the end of Phase 1a or until the DLT threshold is reached; up to 27 months
To assess the disease control rate at >=12 weeks in participants treated with OKN4395 as monotherapy and in combination with pembrolizumab in selected cancer types. (Phase 1a)
From enrolment of the first participant until the end of Phase 1a or until the DLT threshold is reached; up to 27 months
To assess the duration of response in participants treated with OKN4395 as monotherapy and in combination with pembrolizumab in selected cancer types. (Phase 1a)
From enrolment of the first participant until the end of Phase 1a or until the DLT threshold is reached; up to 27 months
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Monotherapy Dose Escalation Phase (Phase 1a)EXPERIMENTALThe Monotherapy Escalation Phase will include increasing doses of OKN4395 alone in patients with solid tumors with a COX2-associated immunosuppressive pathway.
Combination Dose Confirmation Phase (Phase 1a)EXPERIMENTALThe Combination Dose Confirmation Phase will include increasing or decreasing doses of OKN4395 in combination with pembrolizumab in patients with solid tumors with a COX2-associated immunosuppressive pathway. The first dose level used will be 1 level below the identified OBD/MTD for monotherapy. Subsequent dose levels tested will either be increased or decreased in response to observed toxicity.
Phase 1b Cohort 1: Sarcoma Food Effect (Fasted)EXPERIMENTALFasted first dose, and OBD/MTD (mono) dose of OKN4395 as monotherapy for the remainder of treatment.
Phase 1b Cohort 1: Sarcoma Food Effect (Fed)EXPERIMENTALFed first dose, and OBD/MTD (mono) dose of OKN4395 as monotherapy for the remainder of treatment.
Phase 1b Cohort 2: Pancreas Gastric pH Effect (with H2RA)EXPERIMENTALCo-administered H2RA (H2 receptor antagonist; famotidine) first dose, and OBD/MTD (mono) dose of OKN4395 as monotherapy for the remainder of treatment.
Phase 1b Cohort 2: Pancreas Gastric pH Effect (without H2RA)EXPERIMENTALNo co-administered H2RA (H2 receptor antagonist; famotidine) first dose, and OBD/MTD (mono) dose of OKN4395 as monotherapy for the remainder of treatment.
Phase 1b Cohort 3: NSCLCEXPERIMENTALOKN4395 (OBD/MTD combination dose) in combination with pembrolizumab
Phase 1b Cohort 4: Colorectal CancerEXPERIMENTALOKN4395 (OBD/MTD combination dose) in combination with pembrolizumab
Phase 1b Cohort 5: HNSCCEXPERIMENTALOKN4395 (OBD/MTD combination dose) in combination with pembrolizumab
Interventions
NameTypeDescription
OKN4395DRUGOKN4395 oral dosing twice per day
PembrolizumabCOMBINATION_PRODUCT200 mg IV every 3 weeks
FastingOTHERFasting before first dose of OKN4395
FedOTHERFood provided to patient before first OKN4395 dose
H2 Receptor AntagonistDRUGFamotidine 20 mg IV (as a slow push over 2 minutes) administered 3 hours prior to OKN4395
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites10

Inclusion Criteria: 1. 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 longer effective, refused or not tolerated. Fo...

Countries:United StatesAustraliaUnited Kingdom
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Competitive Landscape -Other Solid Tumors 9 trials
CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK2PHASE2pembrolizumab, V503, GARDASIL
Incyte CorporationINCY1PHASE2Chemotherapy, Retifanlimab
Novartis AG Sponsored ADRNVS1PHASE1KFA115, pembrolizumab
Iovance Biotherapeutics IncIOVA2PHASE2E7 TCR-T cells, Aldesleukin
AstraZeneca PLCAZN1 — Trastuzumab deruxtecan
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT06789172studyFirstPostDate: changed