A Phase 1, First-in-human Study of OKN4395 and Pembrolizumab in Patients With Solid Tumors
NCT06789172
This study is recruiting at 3 US sites in 2 states, according to its ClinicalTrials.gov record last updated .
Summary
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. This study will be split into 2 parts.
Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov
Conditions studied
- Solid Tumours
- Sarcoma
- HNSCC
- Non Small Cell Lung Cancer
- NSCLC
- Colorectal Cancer (CRC)
- Myxofibrosarcoma (MFS)
- Solitary Fibrous Tumors
- Dedifferentiated Liposarcoma
- Undifferentiated Pleomorphic Sarcoma (UPS)
- Leiomyosarcoma
- Leiomyosarcoma (LMS)
- Gastric Cancer (GC)
- Gastric Cancer Adenocarcinoma Metastatic
- Gastric / Gastroesophageal Junction Adenocarcinoma
Eligibility basics and study details
- Study type
- Interventional
- Phase
- Phase 1
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Sponsor
- Epkin
- Last updated on ClinicalTrials.gov
- June 11, 2026
These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.
US recruiting sites
California · 2
- Precision NextGen Oncology and Research Center · Beverly Hills, CA
- Sarcoma Oncology Center · Santa Monica, CA
Texas · 1
- MD Anderson Cancer Center · Houston, TX
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.