NCT06789172 - A Phase 1, First-in-human Study of OKN4395 and Pembrolizumab in Patients With Solid Tumors | Biotech Hunter

Enrollment

166

Participants

Timeline

Start Date

January 23, 2025

Primary Completion Date

July 31, 2028

Study Completion Date

September 30, 2028

Conditions

Solid TumoursSarcomaHNSCCNon Small Cell Lung CancerHead and Neck Squamous Cell CarcinomaNSCLCPancreatic AdenocarcinomaColorectal Cancer (CRC)Myxofibrosarcoma (MFS)Solitary Fibrous TumorsDedifferentiated LiposarcomaUndifferentiated Pleomorphic Sarcoma (UPS)

Interventions

DRUG

OKN4395

OKN4395 oral dosing twice per day

COMBINATION_PRODUCT

Pembrolizumab

200 mg IV every 3 weeks

OTHER

Fasting

Fasting before first dose of OKN4395

OTHER

Fed

Food provided to patient before first OKN4395 dose

DRUG

H2 Receptor Antagonist

Famotidine 20 mg IV (as a slow push over 2 minutes) administered 3 hours prior to OKN4395

Trial Locations (10)

6009

RECRUITING

Linear Clinical Research, Perth

77030

RECRUITING

MD Anderson Cancer Center, Houston

90212

RECRUITING

Precision NextGen Oncology and Research Center, Beverly Hills

90403

RECRUITING

Sarcoma Oncology Center, Santa Monica

Unknown

RECRUITING

Chris O'Brien Lifehouse, Sydney

RECRUITING

The Beatson, Glasgow

RECRUITING

University College London Hospital, London

RECRUITING

The Christie, Manchester

RECRUITING

Churchill Hospital, Oxford

LE1 5WW

RECRUITING

Leicester Royal Infirmary, Leicester