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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06026410
Other study ID # KO-2806-001
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date October 18, 2023
Est. completion date April 2027

Study information

Verified date April 2024
Source Kura Oncology, Inc.
Contact Clinical Operations
Phone 617-588-3755
Email KO-2806-001@kuraoncology.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This first-in-human (FIH) dose-escalation and dose-validation/expansion study will assess KO-2806, a farnesyl transferase inhibitor (FTI), as a monotherapy and in combination, in adult patients with advanced solid tumors.


Recruitment information / eligibility

Status Recruiting
Enrollment 270
Est. completion date April 2027
Est. primary completion date January 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - At least 18 years of age. - Histologically or cytologically confirmed advanced solid tumors - Arm #1 (Monotherapy): HRAS-mutant and/or amplified tumors (any solid tumor type); HRAS overexpression (only for HNSCC tumors); KRAS and/or NRAS, and/or HRAS-mutant and/or amplified NSCLC or CRC; KRAS-mutant and/or amplified PDAC - Arm #2 (Combination): Must have received at least 1 prior systemic therapy with IO-based treatment for locally advanced or metastatic RCC with predominantly clear cell subtype - Arm #3 (Combination): Must have KRAS G12C-mutant locally advanced or metastatic NSCLC and have received at least 1 prior systemic therapy for advanced or metastatic NSCLC - Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. - Karnofsky Performance Status of 70 or higher with no clinically significant deterioration over the previous 2 weeks. - Acceptable liver, renal, endocrine, and hematologic function. - Other protocol-defined inclusion criteria may apply. Exclusion Criteria: - Ongoing treatment with certain anticancer agents. - Prior treatment with an FTI or HRAS inhibitor. - Major surgery, other than local procedures, within 28 days prior to Cycle 1 Day 1, without complete recovery. - Spinal cord compression, leptomeningeal disease, or clinically active CNS metastases. - Toxicity (excluding alopecia) from prior therapy that has not been completely resolved to baseline at the time of consent. - Active or prior documented autoimmune or inflammatory disorders within the past 5 years prior to Cycle 1 Day 1 (with exceptions). - Active, uncontrolled bacterial, viral, or fungal infections requiring systemic therapy. - Inability to swallow, impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the trial drugs. - Inadequate cardiac and/or vascular function, including receipt of treatment for unstable angina, myocardial infarction, and/or cerebro-vascular attack within the prior 6 months, mean QTcF =470 ms, or Class II or greater congestive heart failure. - Other invasive malignancy within 2 years. - Other protocol-defined exclusion criteria may apply.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
KO-2806
Oral administration
Cabozantinib
Oral administration
Adagrasib
Oral administration

Locations

Country Name City State
United States Dana-Farber Cancer Institute Boston Massachusetts
United States AdventHealth Celebration Celebration Florida
United States Sarah Cannon Research Institute at HealthONE Denver Colorado
United States UCLA Department of Medicine Los Angeles California
United States University of Southern California Los Angeles California
United States University of Wisconsin (Carbone Cancer Center) Madison Wisconsin
United States SCRI - Oncology Partners Nashville Tennessee
United States OU Stephenson Cancer Center Oklahoma City Oklahoma
United States Washington University School of Medicine Saint Louis Missouri
United States Florida Cancer Specialists Sarasota Florida

Sponsors (2)

Lead Sponsor Collaborator
Kura Oncology, Inc. Mirati Therapeutics Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of dose-limiting toxicities (DLTs) DLTs will be evaluated during the first 28 days of KO-2806 treatment (dose escalation)
Primary Descriptive statistics of adverse events NCI-CTCAE v5.0 First dose of KO-2806 up to and including 28 days after last dose of KO-2806, or if the patient is lost to follow-up, whichever comes first (dose escalation)
Primary Overall Response Rate (ORR) Assessed per RECIST v1.1 Up to an estimated period of 24 months (dose expansion)
Secondary Rate of dose-limiting toxicities (DLTs) DLTs will be evaluated during the first 28 days of KO-2806 treatment (dose expansion)
Secondary Descriptive statistics of adverse events NCI-CTCAE v5.0 First dose of KO-2806 up to and including 28 days after last dose of KO-2806, or if the patient is lost to follow-up, whichever comes first (dose expansion)
Secondary Objective Response Rate (ORR) Assessed per RECIST v1.1 Up to an estimated period of 24 months (dose escalation)
Secondary Disease control rate (DCR) Assessed per RECIST v1.1 Up to an estimated period of 24 months (dose escalation and expansion)
Secondary Duration of response (DoR) Assessed per RECIST v1.1 Up to an estimated period of 24 months (dose escalation and expansion)
Secondary Progression-Free Survival (PFS) Assessed per RECIST v1.1 Up to an estimated period of 24 months (dose escalation and expansion)
Secondary Overall Survival (OS) Assessed per RECIST v1.1 Up to an estimated period of 24 months (dose escalation and expansion)
Secondary AUClast Area under the curve from time zero to last measurable concentration for KO-2806 (in the absence and presence of food) and combination agent. Cycle 1. Each cycle is 28 days. (Dose escalation and dose expansion).
Secondary AUC0-inf Area under the curve from time zero to infinity post administration for KO-2806 (in the absence and presence of food) and combination agent Cycle 1. Each cycle is 28 days. (Dose escalation and dose expansion).
Secondary Cmax Maximum plasma concentration (Cmax) of KO-2806 (in the absence and presence of food) and the combination agent Cycle 1. Each cycle is 28 days. (Dose escalation and dose expansion).
Secondary Cmin Minimum plasma concentration (Cmin) of KO-2806 (in the absence and presence of food) and the combination agent Cycle 1. Each cycle is 28 days. (Dose escalation and dose expansion).
Secondary Tmax Time to maximal concentration (Tmax) of KO-2806 (in the absence and presence of food) and the combination agent Cycle 1. Each cycle is 28 days. (Dose escalation and dose expansion).
Secondary Estimated terminal elimination rate constant (?z) Estimated terminal elimination rate constant of KO-2806 and the combination agent Cycle 1. Each cycle is 28 days. (Dose escalation and dose expansion).
Secondary t1/2 Half-life (t1/2) of KO-2806 (in the absence and presence of food) and the combination agent Cycle 1. Each cycle is 28 days. (Dose escalation and dose expansion).
Secondary CL/F Total apparent clearance (CL/F) of KO-2806 and the combination agent Cycle 1. Each cycle is 28 days. (Dose escalation and dose expansion).
Secondary Vd/F Total apparent volume of distribution (Vd/F) of KO-2806 and the combination agent Cycle 1. Each cycle is 28 days. (Dose escalation and dose expansion).
Secondary QTcF QT interval corrected for heart rate (HR) using Fridericia's formula (QTcF) for KO-2806 monotherapy and in combination Up to day 7 following first dose of KO-2806 and adagrasib. Dose escalation.
Secondary KO-2806 plasma concentration measurements Up to day 28 following first dose of KO-2806 and adagrasib. Dose escalation.
Secondary Amount of KO-2806 excretion in urine Up to 24 hours following first dose of KO-2806. Dose escalation.
Secondary CLr of KO-2806 excretion in urine Renal clearance of KO-2806 excretion in urine Up to 24 hours following first dose of KO-2806. Dose escalation.
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