What side effects are associated with this type of intervention?

Common treatments for Renal Cell Carcinoma (RCC) include tyrosine kinase inhibitors (TKIs) such as sunitinib and pazopanib, immune checkpoint inhibitors (ICIs) like nivolumab, and emerging therapies like Farnesyl Transferase Inhibitors (FTIs). The side effects of TKIs often include hypertension, hand-foot syndrome, diarrhea, and fatigue. ICIs can cause immune-related adverse events such as colitis, hepatitis, pneumonitis, and endocrinopathies. FTIs, while still under investigation, may cause side effects like gastrointestinal disturbances, fatigue, and hematologic abnormalities. Patients should discuss these potential side effects with their healthcare provider to make informed treatment decisions.

What prior FDA approvals exist?

The FDA has approved several treatments for Renal Cell Carcinoma (RCC), including targeted therapies and immunotherapies. Targeted therapies such as sunitinib, pazopanib, and axitinib inhibit vascular endothelial growth factor receptors (VEGFR), while everolimus and temsirolimus inhibit the mammalian target of rapamycin (mTOR). Immunotherapies like nivolumab and pembrolizumab, which target PD-1, have also been approved. Although specific information on Farnesyl Transferase Inhibitors (FTIs) for RCC is limited, these approved treatments reflect the diverse approaches in managing RCC.

What other types of research exist?

Promising novel alternatives to KO-2806 for Renal Cell Carcinoma patients include tyrosine kinase inhibitors such as cabozantinib, lenvatinib, and axitinib, as well as mTOR inhibitors like everolimus and temsirolimus. Additionally, immune checkpoint inhibitors such as nivolumab and pembrolizumab are also considered effective options.

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Farnesyl transferase inhibitor

KO-2806 + Cabozantinib for Solid Cancers (FIT-001 Trial)

Phase 1

Recruiting

Research Sponsored by Kura Oncology, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

At least 18 years of age

Must not have

Other invasive malignancy within 2 years

Ongoing treatment with certain anticancer agents

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to an estimated period of 24 months (dose expansion)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing KO-2806, a new drug that blocks an enzyme helping cancer cells grow, in adults with advanced solid tumors. The goal is to see if it can slow down or stop tumor growth, either alone or with other treatments.

Who is the study for?

Adults with advanced solid tumors, including specific types of colorectal, pancreatic, renal cell carcinoma, and non-small cell lung cancer. Participants must be over 18 with acceptable organ function and measurable disease. Some groups require prior treatments or certain genetic features in their tumors.

What is being tested?

KO-2806 is being tested both alone and combined with Cabozantinib to see how well it works for treating various advanced solid tumors. The trial will gradually increase doses to find the safest and most effective levels.

What are the potential side effects?

Potential side effects may include issues related to liver, kidney or blood health due to KO-2806's nature as a farnesyl transferase inhibitor. Specific side effects are not listed but would typically relate to the drug's action on cellular proteins.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had at least one treatment for advanced kidney cancer that included immunotherapy.

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I am 18 years old or older.

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My cancer is confirmed to be advanced through testing.

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My tumor has HRAS, KRAS, or NRAS mutations or is amplified.

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I can care for myself and my health hasn't worsened in the last 2 weeks.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had any other cancer besides this one in the last 2 years.

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I am currently on cancer treatment medication.

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I have previously been treated with an FTI or HRAS inhibitor.

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I haven't had major surgery in the last 28 days or I've fully recovered from it.

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I do not have active cancer spread to my brain or spinal cord.

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I do not have any ongoing serious infections needing treatment.

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I have not had recent serious heart or blood vessel problems.

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I cannot swallow properly or have a GI condition that affects drug absorption.

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I still have side effects from previous treatments, except for hair loss.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to an estimated period of 24 months (dose expansion)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to an estimated period of 24 months (dose expansion)

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to an estimated period of 24 months (dose expansion) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall Response Rate (ORR)

Secondary study objectives

AUC0-inf

AUClast

CL/F

+14 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Arm #3: Advanced or metastatic NSCLCExperimental Treatment2 Interventions

Patients with KRAS G12C-mutant locally advanced or metastatic NSCLC who have received at least 1 prior systemic therapy for advanced or metastatic NSCLC

Group II: Arm #2: Advanced or metastatic ccRCCExperimental Treatment2 Interventions

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

Group III: Arm #1: RAS-altered advanced solid tumorsExperimental Treatment1 Intervention

Patients with advanced solid tumors and the following: * 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 for NSCLC or CRC * KRAS-mutant and/or amplified PDAC

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cabozantinib

2020

Completed Phase 2

~2360

Adagrasib

2023

Completed Phase 1

~20

0 / 14Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Renal Cell Carcinoma (RCC) include targeted therapies, immunotherapies, and emerging treatments like Farnesyl Transferase Inhibitors (FTIs). Targeted therapies, such as tyrosine kinase inhibitors (e.g., sunitinib) and mTOR inhibitors (e.g., everolimus), work by blocking specific pathways that promote tumor growth and angiogenesis. Immunotherapies, including checkpoint inhibitors like nivolumab, enhance the body's immune response against cancer cells. FTIs, like KO-2806, inhibit the enzyme farnesyl transferase, which is essential for the activation of certain oncogenes, thereby preventing cancer cell proliferation. These treatments are crucial for RCC patients as they offer more personalized and effective options, potentially improving survival rates and quality of life.