First-in-Human Study of KO-947 in Non-Hematological Malignancies

Stopped early · Phase 1

Conditions studied: Advanced Malignant Neoplasm

In brief

This phase 1 first-in-human (FIH) dose escalation study will determine the maximum tolerated dose (MTD) of KO-947 in subjects with locally advanced unresectable or metastatic, relapsed and/or refractory, non-hematological malignancies. If an MTD cannot be identified, a recommended phase 2 dose (RP2D) will be determined. In addition, two tumor specific extension cohorts may be conducted to further characterize the safety and tolerability of KO-947 and provide preliminary evidence of anti-tumor activity.

Key facts

Study ID

NCT03051035

Run by

Kura Oncology, Inc.

People needed

61

Starts

2017-04-06

Expected to finish

2020-06-02

Last updated by the study team

2021-09-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Ongoing treatment with an anticancer agent.
• History of prior significant toxicity (Grade 2 or higher that required permanent treatment discontinuation) from a BRAF, MEK (MAPK [Mitogen-activated protein]/ERK kinase) or ERK inhibitor.
• History of retinal vein occlusion, neurosensory retinal detachment, or neovascular macular degeneration. Evidence of visible retinal pathology as assessed by ophthalmologic examination that is considered a risk factor for retinal vein thrombosis or neurosensory retinal detachment.
• Mean QTcF of >470 ms on triplicate ECGs performed within 5 minutes of each other; subjects currently taking drugs known to be associated with prolonging the QT interval for which there are no adequate therapeutic substitutes; subjects with congenital long QT syndrome. As a guide to known drugs associated with QTc prolongation, please refer to the following Credible Meds web page for a list of drugs that prolong QT and/or cause torsades de pointes, https://crediblemeds.org/pdftemp/pdf/CombinedList.pdf
• Allergy or hypersensitivity to components of the KO-947 formulation, e.g. dextrose, hydroxypropyl beta cyclodextrin, acetic acid, sodium acetate and water for injection.
• Participation in any interventional study within 4 weeks of Cycle 1 Day 1 or 5 half-lives of the investigational agent(s) used in the interventional study prior to Cycle 1 Day 1 (whichever is shorter).
• Grade >1 gastrointestinal toxicity that cannot be managed with supportive care measures.
• Received treatment for unstable angina within the prior year, myocardial infarction within the prior year, cerebro-vascular attack within the prior year, history of New York Heart Association grade III or greater congestive heart failure, or current serious cardiac arrhythmia requiring medication except atrial fibrillation.
• Known uncontrolled brain, leptomeningeal or epidural metastases (unless treated and well controlled for at least 4 weeks prior to Cycle 1 Day 1). Controlled brain metastases that require continuous high dose corticosteroid use within 4 weeks of Cycle 1 Day 1.
• Major surgery, other than diagnostic surgery, within 4 weeks prior to Cycle 1 Day 1, without complete recovery.
• Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy. Known infection with human immunodeficiency virus, or an active infection with hepatitis B or hepatitis C.

Where it is running

• Mayo Clinic — Rochester, Minnesota, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
• Vall D'Hebron Institute of Oncology — Barcelona, Spain
• START Madrid-HM CIOCC — Madrid, Spain

Full record on ClinicalTrials.gov

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