Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING Phase 1

First-in-Human Study of OKI-219 in Advanced Solid Tumors and Advanced Breast Cancer

NCT06239467 · View on ClinicalTrials.gov ↗

Study Summary

OKI-219-101 is a Phase 1a/1b, open-label, multicenter, dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PDx), and efficacy of OKI-219 as monotherapy and in combination with other anti-cancer drugs. Phase 1a (Part A) will investigate escalating doses of OKI-219 monotherapy, and Phase 1b will investigate OKI-219 (at a tolerated dose determined in Part A) in combination with fulvestrant (Part B), trastuzumab and tucatinib (Part C), atirmociclib (Part D), and ribociclib and fulvestrant (Part E). Participants will continue to receive study treatment until disease progression, intolerable toxicity, or other study treatment withdrawal criteria are met.

Interventions

  • DRUG Trastuzumab
  • DRUG Fulvestrant
  • DRUG Tucatinib
  • DRUG Atirmociclib
  • DRUG OKI-219

Study Locations (20)

Other

  • Institut Jules Bordet — Anderlecht
  • UZ Leuven - Campus Gasthuisberg — Leuven
  • GZA Hopsitals Campus Sint-Augustinus — Wilrijk
  • Centre de Lutte Contre le Cancer CLCC - Centre Georges Francois Leclerc (CGFL) — Dijon
  • Centre Oscar Lambret — Lille
  • Centre Leon Berard — Lyon
  • Centre Antoine Lacassagne — Nice

California

  • California Cancer Associates for Research and Excellence — Encinitas
  • University of California San Diego UCSD — La Jolla
  • UCLA Jonsson Comprehensive Cancer Center — Los Angeles
  • Hoag - Huntington Beach — Newport Beach

Colorado

  • Regents of the University of Colorado — Aurora
  • Sarah Cannon Research Institute at HealthONE — Denver

Massachusetts

  • Massachusetts General Hospital — Boston

Michigan

  • Karmanos Cancer Insitute — Detroit

Nevada

  • Comprehensive Cancer Centers of Nevada — Las Vegas

New York

  • Stony Brook University — Stony Brook

Tennessee

  • SCRI Oncology Partners - Nashville — Nashville

Trial Details

FieldValue
Enrollment Target 200 participants
Start Date 2024-02-26
Est. Completion 2027-08-01
Phase Phase 1

Sponsor

OnKure

1 total trials

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical trial.

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06239467

The ClinicalTrials.gov registry entry for NCT06239467 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is OnKure, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 4 conditions, with Breast Cancer appearing as the primary indexed condition, and to 5 interventions — of which Trastuzumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06239467 reports 20 study locations spanning 10 distinct geographic areas — top geographies include Other, California, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06239467 about?

NCT06239467 is a clinical study titled "First-in-Human Study of OKI-219 in Advanced Solid Tumors and Advanced Breast Cancer". OKI-219-101 is a Phase 1a/1b, open-label, multicenter, dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PDx), and efficacy of OKI-219 as monotherapy and in combination with other anti-cancer drugs. Phase 1a (Part A) will investigate escala...

What is the current status of trial NCT06239467?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 200 participants. The study started on 2024-02-26. Estimated completion is 2027-08-01.

What conditions does trial NCT06239467 study?

This clinical trial studies the following conditions: Breast Cancer, Advanced Solid Tumors, Advanced Cancer, PI3K Gene Mutation. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06239467?

The interventions under investigation include: Trastuzumab (DRUG), Fulvestrant (DRUG), Tucatinib (DRUG), Atirmociclib (DRUG), OKI-219 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06239467?

This trial is sponsored by OnKure, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06239467 being conducted?

This trial has 20 study locations across California, Colorado, Massachusetts, Michigan, Nevada. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial