Actively Recruiting
Phase 1 Study Evaluating Safety and Preliminary Activity of KO-2806 Alone and in Combination in Adults With Advanced Solid Tumors
Led by Kura Oncology, Inc. · Updated on 2026-06-08
300
Participants Needed
38
Research Sites
12 weeks
Total Duration
On this page
Sponsors
K
Kura Oncology, Inc.
Lead Sponsor
M
Mirati Therapeutics Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating KO-2806, a farnesyltransferase inhibitor (FTI), in adult patients with advanced solid tumors. This first-in-human study is designed to assess KO-2806 as a monotherapy and in combination with other treatments. The trial focuses on patients with specific genetic tumor alterations such as HRAS, KRAS, and NRAS mutations or amplifications, across various solid tumor types including lung, colorectal, pancreatic, and renal cancers. The study includes multiple treatment groups: KO-2806 alone for HRAS-altered tumors; combinations with cabozantinib or adagrasib for advanced or metastatic renal cell carcinoma (RCC), non-small cell lung cancer (NSCLC), colorectal cancer (CRC), and pancreatic ductal adenocarcinoma (PDAC). Treatments are administered orally, with dose escalation and expansion phases to evaluate safety, dosing, and preliminary antitumor activity. Participants will undergo regular assessments including evaluation of adverse events, dose-limiting toxicities, and tumor response using RECIST v1.1 criteria. Pharmacokinetics, pharmacodynamics, and other laboratory tests will be conducted during treatment cycles, which last 28 days each. The trial includes monitoring for up to 24 months of treatment and survival follow-up up to 37 months, aiming to gather detailed safety and efficacy data for KO-2806 in this patient population.
CONDITIONS
Brief Title
KO-2806 Monotherapy and Combination Therapies in Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years of age
- Histologically or cytologically confirmed advanced solid tumors
- Specific genetic alterations for each arm, including HRAS mutations/amplifications, HRAS overexpression (HNSCC only), KRAS/NRAS/HRAS mutations or amplifications in NSCLC or CRC, KRAS mutations/amplifications in PDAC
- Prior systemic therapy including immuno-oncology treatment for RCC, NSCLC, CRC, or PDAC as specified per study arm
- Measurable disease by RECIST v1.1
- Karnofsky Performance Status of 70 or higher with no significant decline in the past 2 weeks
- Acceptable liver, renal, endocrine, and hematologic function
- Other protocol-defined inclusion criteria may apply
You will not qualify if you...
- Use of anticancer therapy within 14 days or 5 half-lives before study treatment
- Prior treatment with farnesyltransferase inhibitors or HRAS inhibitors
- Major surgery within 28 days before treatment without full recovery
- Spinal cord compression, leptomeningeal disease, or active central nervous system metastases
- Unresolved toxicity from prior therapy (except hair loss)
- Active or recent autoimmune or inflammatory disorders within 5 years (with exceptions)
- Active uncontrolled infections requiring systemic therapy
- Inability to swallow or gastrointestinal conditions affecting drug absorption
- Poor cardiac or vascular function including recent serious heart events or heart failure class II or higher
- Other invasive cancers within 2 years
- Other protocol-defined exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months
Participants receive oral KO-2806 alone or in combination with other drugs to evaluate safety and preliminary activity in advanced solid tumors.
Repeated visits during treatment cycles of 28 days each
Duration - Up to 13 months after treatment
Participants are monitored for safety and overall survival after completing treatment.
Visits continued up to 37 months from first dose including safety assessments
Trial Site Locations
Total: 38 locations
1
Mayo Clinic Comprehensive Cancer Center
Phoenix, Arizona, United States, 85054
Actively Recruiting
2
University of Arizona
Tucson, Arizona, United States, 85724
Actively Recruiting
3
University of Southern California
Los Angeles, California, United States, 90033
Actively Recruiting
4
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
5
UCLA Department of Medicine
Los Angeles, California, United States, 90095
Actively Recruiting
6
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, United States, 80218
Actively Recruiting
7
AdventHealth Celebration
Celebration, Florida, United States, 34747
Actively Recruiting
8
Mayo Clinic Comprehensive Cancer Center
Jacksonville, Florida, United States, 32224
Actively Recruiting
9
Florida Cancer Specialists
Sarasota, Florida, United States, 34232
Actively Recruiting
10
University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States, 52242
Actively Recruiting
11
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
12
Henry Ford Health System
Detroit, Michigan, United States, 48202
Actively Recruiting
13
Mayo Clinic Comprehensive Cancer Center
Rochester, Minnesota, United States, 55905
Actively Recruiting
14
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
15
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08901
Actively Recruiting
16
Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
17
OU Stephenson Cancer Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
18
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
19
SCRI - Oncology Partners
Nashville, Tennessee, United States, 37203
Actively Recruiting
20
UT Southwestern Simmons Cancer Center
Dallas, Texas, United States, 75235
Actively Recruiting
21
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
22
University of Wisconsin (Carbone Cancer Center)
Madison, Wisconsin, United States, 53792
Actively Recruiting
23
Centre Leon Berard
Lyon, France, 69495
Actively Recruiting
24
Oncologie médicale - Pitié-Salpêtrière
Paris, France, 75013
Actively Recruiting
25
Hopital Européen Georges Pompidou
Paris, France, 75015
Actively Recruiting
26
Institut Universitaire du Cancer Toulouse - Oncopole
Toulouse, France, 31059
Actively Recruiting
27
Charité - Universitätsmedizin Berlin
Berlin, Germany, 12203
Actively Recruiting
28
Universitätsklinikum Ulm
Ulm, Germany, 89081
Actively Recruiting
29
Universitätsklinikum Würzburg
Würzburg, Germany, 97080
Actively Recruiting
30
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS
Bologna, Italy, 40138
Actively Recruiting
31
Fondazione Piemonte per l'Oncologia - IRCCs Candiolo
Candiolo, Italy, 10060
Actively Recruiting
32
Istituto Nazionale Tumori IRCCS
Naples, Italy, 80131
Actively Recruiting
33
Humanitas University
Rozzano, Italy, 20089
Actively Recruiting
34
AOU Verona - Centro Ricerche Cliniche di Verona
Verona, Italy, 37134
Actively Recruiting
35
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035
Actively Recruiting
36
Hospital de la Santa Creu i de Sant Pau
Barcelona, Spain, 08041
Actively Recruiting
37
Hospital HM Sanchinarro START Madrid-CIOCC
Madrid, Spain, 28050
Actively Recruiting
38
Hospital Universitario Virgen del Rocío
Seville, Spain, 41013
Actively Recruiting
Research Team
K
Kura Medical Information
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
7
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