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New drug combo targets Hard-to-Treat cancers in early trial

NCT ID NCT06026410

Disease control Sponsor: Kura Oncology, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This early-stage trial tests a new drug called KO-2806, alone or with other cancer drugs, in adults with advanced solid tumors that have not responded to standard treatments. The study aims to find safe doses and check for early signs of tumor shrinkage. About 300 participants will be enrolled across multiple sites.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
KO-2806 (darlifarnib), cabozantinib, adagrasib
What this could lead to
If successful, this could point toward a new treatment option for certain advanced solid tumors that have not responded to standard therapies.
What could go wrong
This is an early Phase 1 trial, so safety and effectiveness are not yet established. Many drugs fail at this stage, and side effects may be significant.
Why investors are watching

Kura Oncology is testing its drug KO-2806 in people with advanced solid tumors for the first time. This early-stage trial checks safety and whether the drug shrinks tumors, alone or with other treatments. For a small company, this readout matters because it is the first real test of whether the drug works in humans.

If it works: If the drug proves safe and shows signs of shrinking tumors, Kura could move it into later-stage trials. That would give the company a stronger position to attract partners or funding for further development.

If it fails: Most drugs fail in early human trials, often because they are unsafe or do not work as hoped. A poor result or a delay in this study could set Kura back and reduce confidence in its pipeline.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2023

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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. * 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 cerebrovascular 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.

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Conditions

The condition(s) this trial relates to.

colorectal cancer colorectal neoplasm kidney cancer neoplasm non-small cell lung carcinoma nonpapillary renal cell carcinoma pancreatic ductal adenocarcinoma renal cell carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Clear cell renal cell carcinoma (CCRCC) Colorectal cancer (CRC) Non-clear cell renal cell carcinoma (NCCRCC) Non-small cell lung cancer (NSCLC) Pancreatic ductal adenocarcinoma (PDAC) Renal cell carcinoma (kidney cancer) Solid tumors with hras alterations

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    38 sites in 5 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • AOU Verona - Centro Ricerche Cliniche di Verona

    RECRUITING

    Verona, 37134, Italy

  • AdventHealth Celebration

    RECRUITING

    Celebration, Florida, 34747, United States

  • Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS

    RECRUITING

    Bologna, 40138, Italy

  • Cedars-Sinai Medical Center

    RECRUITING

    Los Angeles, California, 90048, United States

  • Centre Leon Berard

    RECRUITING

    Lyon, 69495, France

  • Charité - Universitätsmedizin Berlin

    RECRUITING

    Berlin, 12203, Germany

  • Dana-Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Florida Cancer Specialists

    RECRUITING

    Sarasota, Florida, 34232, United States

  • Fondazione Piemonte per l'Oncologia - IRCCs Candiolo

    RECRUITING

    Candiolo, 10060, Italy

  • Henry Ford Health System

    RECRUITING

    Detroit, Michigan, 48202, United States

  • Hopital Européen Georges Pompidou

    RECRUITING

    Paris, 75015, France

  • Hospital HM Sanchinarro START Madrid-CIOCC

    RECRUITING

    Madrid, 28050, Spain

  • Hospital Universitari Vall d'Hebron

    RECRUITING

    Barcelona, 08035, Spain

  • Hospital Universitario Virgen del Rocío

    RECRUITING

    Seville, 41013, Spain

  • Hospital de la Santa Creu i de Sant Pau

    RECRUITING

    Barcelona, 08041, Spain

  • Humanitas University

    RECRUITING

    Rozzano, 20089, Italy

  • Institut Universitaire du Cancer Toulouse - Oncopole

    RECRUITING

    Toulouse, 31059, France

  • Istituto Nazionale Tumori IRCCS

    RECRUITING

    Naples, 80131, Italy

  • MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • Mayo Clinic Comprehensive Cancer Center

    RECRUITING

    Phoenix, Arizona, 85054, United States

  • Mayo Clinic Comprehensive Cancer Center

    RECRUITING

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic Comprehensive Cancer Center

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • OU Stephenson Cancer Center

    RECRUITING

    Oklahoma City, Oklahoma, 73104, United States

  • Ohio State University

    RECRUITING

    Columbus, Ohio, 43210, United States

  • Oncologie médicale - Pitié-Salpêtrière

    RECRUITING

    Paris, 75013, France

  • Rutgers Cancer Institute of New Jersey

    RECRUITING

    New Brunswick, New Jersey, 08901, United States

  • SCRI - Oncology Partners

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Sarah Cannon Research Institute at HealthONE

    RECRUITING

    Denver, Colorado, 80218, United States

  • UCLA Department of Medicine

    RECRUITING

    Los Angeles, California, 90095, United States

  • UPMC Hillman Cancer Center

    RECRUITING

    Pittsburgh, Pennsylvania, 15232, United States

  • UT Southwestern Simmons Cancer Center

    RECRUITING

    Dallas, Texas, 75235, United States

  • University of Arizona

    RECRUITING

    Tucson, Arizona, 85724, United States

  • University of Iowa Hospitals & Clinics

    RECRUITING

    Iowa City, Iowa, 52242, United States

  • University of Southern California

    RECRUITING

    Los Angeles, California, 90033, United States

  • University of Wisconsin (Carbone Cancer Center)

    RECRUITING

    Madison, Wisconsin, 53792, United States

    Contact Email: •••••@•••••

  • Universitätsklinikum Ulm

    RECRUITING

    Ulm, 89081, Germany

  • Universitätsklinikum Würzburg

    RECRUITING

    Würzburg, 97080, Germany

  • Washington University School of Medicine

    RECRUITING

    St Louis, Missouri, 63110, United States

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