Recently added Catalysts

OKN4395

Phase 1

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

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

CONTROLLEDBiomarker

Total Trials1

Total Enrollment166

FDA Designations

No designations recorded

Clinical trial landscape

OKN4395 · 1 trial · 12 indications

Phase 1 1

Indication

NCT06789172A Phase 1, First-in-human Study of OKN4395 and Pembrolizumab in Patients With Solid TumorsSolid Tumours

RECRUITING166 Analytics

PHASE1RECRUITING

A Phase 1, First-in-human Study of OKN4395 and Pembrolizumab in Patients With Solid Tumors

Solid Tumours

Unlock trial analytics

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

Unlock Study Endpoints

Study Design & Arms

AllocationNON_RANDOMIZED

MaskingNONE

ModelPARALLEL

PurposeTREATMENT

Treatment Arms

Arm	Type	Description
Monotherapy Dose Escalation Phase (Phase 1a)	EXPERIMENTAL	The 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)	EXPERIMENTAL	The 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)	EXPERIMENTAL	Fasted first dose, and OBD/MTD (mono) dose of OKN4395 as monotherapy for the remainder of treatment.
Phase 1b Cohort 1: Sarcoma Food Effect (Fed)	EXPERIMENTAL	Fed 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)	EXPERIMENTAL	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 2: Pancreas Gastric pH Effect (without H2RA)	EXPERIMENTAL	No 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: NSCLC	EXPERIMENTAL	OKN4395 (OBD/MTD combination dose) in combination with pembrolizumab
Phase 1b Cohort 4: Colorectal Cancer	EXPERIMENTAL	OKN4395 (OBD/MTD combination dose) in combination with pembrolizumab
Phase 1b Cohort 5: HNSCC	EXPERIMENTAL	OKN4395 (OBD/MTD combination dose) in combination with pembrolizumab

Interventions

Name	Type	Description
OKN4395	DRUG	OKN4395 oral dosing twice per day
Pembrolizumab	COMBINATION_PRODUCT	200 mg IV every 3 weeks
Fasting	OTHER	Fasting before first dose of OKN4395
Fed	OTHER	Food provided to patient before first OKN4395 dose
H2 Receptor Antagonist	DRUG	Famotidine 20 mg IV (as a slow push over 2 minutes) administered 3 hours prior to OKN4395

Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 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

Unlock Eligibility Criteria

Competitive Landscape -Other Solid Tumors 9 trials (matched to "Solid Tumours")

Company	Ticker	Trials	Lead Phase	Drugs
Merck & Co., Inc.	MRK	2	PHASE2	pembrolizumab
Incyte Corporation	INCY	1	PHASE2	Chemotherapy, Retifanlimab
Iovance Biotherapeutics Inc	IOVA	2	PHASE2	E7 TCR-T cells, Aldesleukin
Novartis AG Sponsored ADR	NVS	1	PHASE1	KFA115, pembrolizumab
AstraZeneca PLC	AZN	1	-	Trastuzumab deruxtecan

Unlock Competitive Intelligence

Frequently asked questions about OKN4395

What is OKN4395 used for in solid tumors?

OKN4395 is an investigational small molecule being studied for the treatment of solid tumors, including sarcoma, head and neck squamous cell carcinoma, non-small cell lung cancer, pancreatic adenocarcinoma, colorectal cancer, myxofibrosarcoma, solitary fibrous tumors, dedifferentiated liposarcoma, and undifferentiated pleomorphic sarcoma. It is currently in Phase 1 clinical development.

Who is developing OKN4395?

OKN4395 is being developed by Precision BioSciences, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol DTIL. The company is conducting a Phase 1 first-in-human study of OKN4395 in combination with pembrolizumab in patients with solid tumors.

What phase is OKN4395 in?

OKN4395 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The ongoing Phase 1 trial is a first-in-human study evaluating OKN4395 in combination with pembrolizumab in patients with solid tumors.

What clinical trials is OKN4395 in?

OKN4395 is being evaluated in one active Phase 1 clinical trial with the identifier NCT06789172. This first-in-human study is recruiting patients with solid tumors and is being conducted in the United States, Australia, and the United Kingdom. The trial has a planned enrollment of 166 participants.

Is OKN4395 the same as pembrolizumab?

No, OKN4395 is not the same as pembrolizumab. OKN4395 is an investigational small molecule being studied in combination with pembrolizumab, which is an approved immunotherapy. The Phase 1 trial NCT06789172 is evaluating the safety and efficacy of OKN4395 when given together with pembrolizumab in patients with solid tumors.