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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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

FIT-001 Trial Summary

This trial will assess an FTI drug, KO-2806, as a monotherapy and in combination for treating advanced solid tumors.

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.Check my eligibility

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.See study design

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.

FIT-001 Trial 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.

FIT-001 Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall Response Rate (ORR)

Secondary outcome measures

AUC0-inf

AUClast

Amount of KO-2806 excretion in urine

+17 more

FIT-001 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

Adagrasib

2023

Completed Phase 1

~20

Cabozantinib

2020

Completed Phase 2

~1760

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mirati Therapeutics Inc.Industry Sponsor

70 Previous Clinical Trials

7,935 Total Patients Enrolled

Kura Oncology, Inc.Lead Sponsor

15 Previous Clinical Trials

1,252 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the Food and Drug Administration's (FDA) status of Arm #2: Advanced or metastatic ccRCC?

"Data from Power's team gives Arm #2: Advanced or metastatic ccRCC a score of 1, as the safety and efficacy have yet to be fully ascertained in Phase 1 trials."

Answered by AI

Is this research initiative currently accepting participants?

"The information found on clinicaltrials.gov suggests that this medical trial is currently recruiting patients. It was initially made available to the public on October 1st, 2023 and underwent its most recent update nine days later."

Answered by AI

What is the aggregate number of participants in this experiment?

"This clinical trial requires 270 qualified participants. Those eligible to take part in the research can do so at Dana-Farber Cancer Institute and Washington University School of Medicine, among other locations around the US."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

KO-2806 Monotherapy and Combination Therapies in Advanced Solid Tumors

2023. "KO-2806 Monotherapy and Combination Therapies in Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06026410.

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