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KO-2806 Monotherapy and Combination Therapies in Advanced Solid Tumors

ConditionsSolid Tumors With HRAS AlterationsNon Small Cell Lung Cancer (NSCLC)Colorectal Cancer (CRC)Pancreatic Ductal Adenocarcinoma (PDAC)Clear Cell Renal Cell Carcinoma (ccRCC)Renal Cell Carcinoma (Kidney Cancer)Non Clear Cell Renal Cell Carcinoma (nccRCC)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorKura Oncology, Inc.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

At least 18 years of age.

Histologically or cytologically confirmed advanced solid tumors

Arm #1 (KO-2806 monotherapy): Patients who have progressed on, or are refractory to, standard of care (SOC) treatments with advanced solid tumors, specifically: 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): Patients who have received at least 1 prior systemic therapy with IO-based treatment for locally advanced or metastatic RCC with predominantly clear cell subtype; non-clear cell RCC patients who are either treatment-naïve or have received any prior systemic treatment for locally advanced and metastatic RCC.

Disqualifiers

Any use of anticancer therapy within 14 days or 5 half-lives (whichever is shorter) of Cycle 1 Day 1.

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • Darlifarnib

    Drug

    Oral administration

  • Cabozantinib

    Drug

    Oral administration

  • Adagrasib

    Drug

    Oral administration

Treatment groups

300 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Group A: Arm #1: RAS-altered advanced solid tumors, monotherapy (escalation phase)Experimental treatment 1 intervention
Group B: Arm #2: Advanced or metastatic RCC, combination therapy (escalation phase)Experimental treatment 2 interventions
Group C: Arm #3: Advanced or metastatic NSCLC, CRC, or PDAC, combination therapy (escalation phase)Experimental treatment 2 interventions
Group D: Arm #4: Advanced or metastatic ccRCC, combination therapy (expansion phase)Experimental treatment 2 interventions
Group E: Arm #5: Advanced or metastatic ccRCC, monotherapy (expansion phase)Experimental treatment 1 intervention
Group F: Arm #6: Advanced or metastatic ccRCC, cabozantinib rollover to combination therapy (expansion phase)Experimental treatment 2 interventions
Group G: Arm #7: Advanced or metastatic NSCLC, combination therapy (expansion phase)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Rate of dose-limiting toxicities (DLTs)

Time frame
DLTs will be evaluated during the first 28 days of KO-2806 treatment (dose escalation)
2

Descriptive statistics of adverse events (AEs)

NCI-CTCAE v5.0

Time frame
First dose of KO-2806 up to and including 28 days after last dose of KO-2806 (dose escalation)
3

Incidence of dose interruptions, reductions, and discontinuations due to AE

Time frame
First dose of KO-2806 up to last dose of KO-2806 or up to 24 months of treatment (dose escalation)
4

Objective Response Rate (ORR)

Assessed per RECIST v1.1

Time frame
Up to an estimated period of 24 months (dose expansion)

Secondary outcomes

1

Incidence of dose interruptions, reductions, and discontinuations due to AE

Time frame
First dose of KO-2806 up to last dose of KO-2806 or up to 24 months of treatment (dose expansion)
2

Descriptive statistics of AEs

NCI-CTCAE v5.0

Time frame
First dose of KO-2806 up to and including 28 days after last dose of KO-2806 (dose expansion)
3

Objective Response Rate (ORR)

Assessed per RECIST v1.1

Time frame
Up to an estimated period of 24 months (dose escalation)
4

Disease control rate (DCR)

Assessed per RECIST v1.1

Time frame
Up to an estimated period of 24 months (dose escalation and expansion)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kura Oncology, Inc.

Lead sponsor

Mirati Therapeutics Inc.

Collaborator

Source ClinicalTrials.gov
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