NCT03051035

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

A Phase 1 First-in-Human Study of KO-947 in Locally Advanced Unresectable or Metastatic, Relapsed and/or Refractory Non-Hematological Malignancies

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Kura Oncology, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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. Three dosing schedules will be executed (Schedule 1, 2, or 3). Screening evaluations will be completed following signing of informed consent and within either 21 days or 28 days of Cycle 1 Day 1. Evaluations performed as part of the standard of care within 21/28 days of dosing but prior to consent do not need to be repeated. By signing the consent form, study subjects agree to the collection of standard of care health information. The study will consist of three parts: dose escalation, MTD expansion and tumor specific extension.

Conditions

• Advanced Malignant Neoplasm

Interventions

Type	Name	Description
DRUG	KO-947	Intravenous administration

Timeline

• Start date: 2017-04-06
• Primary completion: 2020-06-02
• Completion: 2020-06-02
• First posted: 2017-02-13
• Last updated: 2021-09-20

Locations

5 sites across 2 countries: United States, Spain

Regulatory

• FDA-regulated drug study