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Taking people in FrancePhase 1

Tests KO-2806 alone and combined with other drugs in advanced solid tumors

Tests KO-2806 alone and with other drugs in adults with advanced solid tumors.

Key facts

Who runs it
Kura Oncology, Inc.
Where
Lyon, Paris, and Toulouse Cedex 9, FranceSee the 3 sitesAlso in 4 other countries, 34 sites
Registry title
KO-2806 Monotherapy and Combination Therapies in Advanced Solid Tumors
Status
Recruiting
Phase
Phase 1
People taking part
300 people, planned
Started
18 Oct 2023
Expected to end
Apr 2027
Type of study
Interventional, 7 groups
Treatments tested
  • Darlifarnib
  • Cabozantinib
  • Adagrasib
Record updated
14 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with advanced solid tumors, such as lung, colorectal, pancreatic or kidney cancer, whose disease has progressed after earlier treatment. It tests KO-2806 alone and with other drugs.

Age
18 years or older.
Sex
All sexes can join.
Disease stage
Advanced or metastatic solid tumors that can be measured by RECIST v1.1. Types include HRAS-mutant tumors, NSCLC, CRC, PDAC and kidney cancer (clear cell or non-clear cell).
Earlier treatment
Depends on the arm. Most arms need at least 1 earlier systemic treatment, and some need earlier immunotherapy-based treatment. Some arms allow no more than 3 earlier anticancer therapies. Some arms need people who have never taken cabozantinib. Earlier treatment with an FTI or HRAS inhibitor is not allowed.
Biomarker or test result
Depends on the arm. HRAS-mutant and/or amplified tumors; KRAS, NRAS and/or HRAS changes in NSCLC or CRC; KRAS-mutant and/or amplified PDAC; HRAS overexpression for head and neck tumors only; KRAS G12C mutation for some combination arms.

Main reasons for not taking part

  • Anticancer therapy within 14 days or 5 half-lives before starting
  • Earlier treatment with an FTI or HRAS inhibitor
  • Spinal cord compression, leptomeningeal disease or active brain metastases
  • Heart problems, including a heart attack or stroke in the past 6 months
  • Another invasive cancer within 2 years

The registry criteria, word for word

Show all 17 criteriaShow less

Who can take part

  • 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; Arm #3 (Combination): Patients who have received at least 1 prior systemic therapy including available approved SOC treatments for KRAS G12C-mutant locally advanced or metastatic NSCLC, CRC, or PDAC; Arm #4 (Combination): Patients must be cabozantinib-naïve and have received at least 1 prior systemic therapy with IO-based treatment for locally advanced or metastatic ccRCC, but no more than 3 prior systemic anticancer therapies; Arm #5 (Cabozantinib monotherapy): Patients must be cabozantinib-naïve and have received at least 1 prior systemic therapy with IO-based treatment for locally advanced or metastatic ccRCC, but no more than 3 prior systemic anticancer therapies; Arm #6 (Cabozantinib rollover to combination): Patients must be cabozantinib-naïve and have received at least 1 prior systemic therapy with IO-based treatment for locally advanced or metastatic ccRCC, but no more than 3 prior systemic anticancer therapies; Arm #7 (Combination): Patients who have received at least 1 prior systemic therapy including available approved SOC treatments for KRAS G12C-mutant locally 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

Who cannot take part

  • 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
  • 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)
  • Inadequate cardiac and/or vascular function, including receipt of treatment for unstable angina, myocardial infarction, and/or cerebrovascular attack within the prior 6 months, mean QTcF ≥470 ms, or Class II or greater congestive heart failure
  • Spinal cord compression, leptomeningeal disease, or clinically active CNS metastases
  • 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
  • Other invasive malignancy within 2 years
  • Other protocol-defined exclusion criteria may apply

Where in France

Also in 4 other countries, 34 sites

  • Centre Leon BerardLyon, FranceTaking people
  • Assistance Publique Hopitaux de ParisParis, FranceTaking people
  • Oncopole Claudius RegaudToulouse Cedex 9, FranceTaking people

About the trial

What the trial wants to find out

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.

The 7 groups in the trial

  • Arm #1: RAS-altered advanced solid tumors, monotherapy (escalation phase)Treatment being tested

    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: Darlifarnib

  • Arm #2: Advanced or metastatic RCC, combination therapy (escalation phase)Treatment being tested

    Patients who have received at least 1 prior systemic therapy with immuno-oncology (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

    Treatment: Darlifarnib and Cabozantinib

  • Arm #3: Advanced or metastatic NSCLC, CRC, or PDAC, combination therapy (escalation phase)Treatment being tested

    Patients with KRAS G12C-mutant locally advanced or metastatic NSCLC, CRC, or PDAC who have received at least 1 prior systemic therapy including available approved standard of care treatments

    Treatment: Darlifarnib and Adagrasib

  • Arm #4: Advanced or metastatic ccRCC, combination therapy (expansion phase)Treatment being tested

    Patients must be cabozantinib-naïve and have received at least 1 prior systemic therapy with IO-based treatment for locally advanced or metastatic ccRCC

    Treatment: Darlifarnib and Cabozantinib

  • Arm #5: Advanced or metastatic ccRCC, monotherapy (expansion phase)Treatment being tested

    Patients must be cabozantinib-naïve and have received at least 1 prior systemic therapy with IO-based treatment for locally advanced or metastatic ccRCC

    Treatment: Cabozantinib

  • Arm #6: Advanced or metastatic ccRCC, cabozantinib rollover to combination therapy (expansion phase)Treatment being tested

    Patients must be cabozantinib-naïve and have received at least 1 prior systemic therapy with IO-based treatment for locally advanced or metastatic ccRCC

    Treatment: Darlifarnib and Cabozantinib

  • Arm #7: Advanced or metastatic NSCLC, combination therapy (expansion phase)Treatment being tested

    Patients with KRAS G12C-mutant locally advanced or metastatic NSCLC who have received at least 1 prior systemic therapy including available approved standard of care treatments

    Treatment: Darlifarnib and Adagrasib

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
Phase 1, First-in-Human, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of KO-2806 When Administered as Monotherapy and in Combination Therapy in Adult Patients With Advanced Solid Tumors
Plain-language title
Tests KO-2806 alone and combined with other drugs in advanced solid tumorsGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
14 October 2026