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Phase 1 Study of OKN4395 and Pembrolizumab for Solid Tumors

This study is testing a new drug called OKN4395, both by itself and in combination with an existing cancer drug, pembrolizumab. The main goals are to understand how safe OKN4395 is, what side effects it might cause (tolerability), how your body handles it, and if it can shrink tumors. You might be able to join if you have a locally advanced or metastatic solid tumor, including sarcoma, head and neck squamous cell carcinoma (HNSCC), or non-small cell lung cancer (NSCLC), and standard treatments are no longer working or suitable for you. The study will look at these effects over a period of up to 27 months.

Study design
This is a Phase 1 study, which means it's one of the first times this drug is being tested in humans. It plans to enroll up to 146 participants to look at different doses of OKN4395 alone or with pembrolizumab.
What's involved
You would receive OKN4395 twice daily by mouth, and if in the combination group, pembrolizumab intravenously (into a vein) every 3 weeks. You may also be asked to fast or eat before your first dose of OKN4395, and receive another medication called famotidine.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for safety and side effects for up to 27 months from the start of the study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06789172

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Epkin
~146 participants
Updated 2026-06-11 on ClinicalTrials.gov
What's tested:OKN4395PembrolizumabFastingFedH2 Receptor Antagonist

At a glance

Recruiting sites
10 of 10 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of DLTs in participants treated with OKN4395 as monotherapy and in combination with pembrolizumab. (Phase 1a)
Measured over From enrolment of the first participant until the end of Phase 1a or until the DLT threshold is reached; up to 27 months
+8 more outcomes measured

Conditions

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

Explore related trials

Colorectal CarcinomaDedifferentiated LiposarcomaGastric CarcinomaGastroesophageal Junction AdenocarcinomaHead and Neck Squamous Cell CarcinomaLeiomyosarcomaLung Non-Small Cell CarcinomaMyxofibrosarcomaSarcomaSolid NeoplasmSolitary Fibrous TumorUndifferentiated Pleomorphic SarcomaMSI1 Gene

NCT06789172

Where you'd take part

This study runs at 10 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Linear Clinical Research

    Perth, Western Australia, Australiastudy coordinator listed

    Recruiting

  • Precision NextGen Oncology and Research Center

    Beverly Hills, Californiastudy coordinator listed

    Recruiting

  • Sarcoma Oncology Center

    Santa Monica, Californiastudy coordinator listed

    Recruiting

  • University College London Hospital

    London, United Kingdomstudy coordinator listed

    Recruiting

  • Chris O'Brien Lifehouse

    Sydney, New South Wales, Australiano site contact published

    Recruiting

  • Churchill Hospital

    Oxford, United Kingdomno site contact published

    Recruiting

  • Leicester Royal Infirmary

    Leicester, United Kingdomno site contact published

    Recruiting

  • MD Anderson Cancer Center

    Houston, Texasno site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Epkin
[email protected]
+33 787922617
Email the study team

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Eligibility criteria

Inclusion

Cohort 1: Sarcoma (fibrous sarcoma \[myxofibrosarcoma or solitary fibrous tumor\], dedifferentiated liposarcoma, undifferentiated pleomorphic sarcoma or pleomorphic sarcoma, or leiomyosarcoma), that is either refractory to or progressing on standard of care, with no more than 3 prior lines of systemic therapy. Patients with a solitary fibrous tumor can be included in the study without prior treatment if, in the investigator's opinion, it is in the participant's best interest and no established standard of care exists or is available.
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 cessation. 2. ECOG performance status of 0 or 1. 3. 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 \[not worsened to Grade \>2 for \>3 months prior to screening\]). 4. 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 administration of the previous systemic therapy \[Phase 1b\] is suitable). In addition (where applicable) an archival tumor biopsy collected before the start of the first-line treatment in the metastatic setting is requested (but optional). 5. At least one target lesion measurable by RECIST 1.1 as noted by local investigators/radiologists. 6. The ability to swallow and retain OKN4395 as an oral medication without significant gastrointestinal abnormalities that might alter absorption. 7. 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 known to affect upper gastrointestinal motility, absorption, and pH. 8. Adequate hematologic, renal, and hepatic function (based on local laboratory assessments):

What this trial measures

  • 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 Cohorts 1-3)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
  • To assess the progression-free survival in participants treated with OKN4395 in combination with pembrolizumab in selected cancer types. (Phase 1b Cohort 4)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