RECRUITING

KO-2806 Monotherapy and Combination Therapies in Advanced Solid Tumors

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Conditions

Solid Tumors with HRAS AlterationsNon Small Cell Lung Cancer (NSCLC)Colorectal Cancer (CRC)Pancreatic Ductal Adenocarcinoma (PDAC)Clear Cell Renal Cell Carcinoma (ccRCC)Renal Cell Carcinoma (Kidney Cancer)HRASKRASNRASFarnesyl transferase inhibitor (FTI)Tyrosine Kinase inhibitor (TKI)Phase 1KRAS G12C inhibitorNSCLCccRCCRCCPDACCRC

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This first-in-human (FIH) dose-escalation and dose-validation/expansion study will assess KO-2806, a farnesyl transferase inhibitor (FTI), as a monotherapy and in combination, in adult patients with advanced solid tumors.

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

Quick Facts

Study Start:2023-10-18
Study Completion:2027-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06026410

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * At least 18 years of age.
  2. * Histologically or cytologically confirmed advanced solid tumors
  3. * Arm #1 (Monotherapy): 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
  4. * Arm #2 (Combination): Must have received at least 1 prior systemic therapy with IO-based treatment for locally advanced or metastatic RCC
  5. * Arm #3 (Combination): Must have KRAS G12C-mutant locally advanced or metastatic NSCLC, CRC, or PDAC and have received at least 1 prior systemic therapy for advanced or metastatic disease
  6. * Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
  7. * Karnofsky Performance Status of 70 or higher with no clinically significant deterioration over the previous 2 weeks.
  8. * Acceptable liver, renal, endocrine, and hematologic function.
  9. * Other protocol-defined inclusion criteria may apply.
  1. * Ongoing treatment with certain anticancer agents.
  2. * Prior treatment with an FTI or HRAS inhibitor.
  3. * Major surgery, other than local procedures, within 28 days prior to Cycle 1 Day 1, without complete recovery.
  4. * Spinal cord compression, leptomeningeal disease, or clinically active CNS metastases.
  5. * Toxicity (excluding alopecia) from prior therapy that has not been completely resolved to baseline at the time of consent.
  6. * Active or prior documented autoimmune or inflammatory disorders within the past 5 years prior to Cycle 1 Day 1 (with exceptions).
  7. * Active, uncontrolled bacterial, viral, or fungal infections requiring systemic therapy.
  8. * Inability to swallow, impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the trial drugs.
  9. * Inadequate cardiac and/or vascular function, including receipt of treatment for unstable angina, myocardial infarction, and/or cerebro-vascular attack within the prior 6 months, mean QTcF ≥470 ms, or Class II or greater congestive heart failure.
  10. * Other invasive malignancy within 2 years.
  11. * Other protocol-defined exclusion criteria may apply.

Contacts and Locations

Study Contact

Clinical Operations
CONTACT
617-588-3755
KO-2806-001@kuraoncology.com

Study Locations (Sites)

University of Southern California
Los Angeles, California, 90033
United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048
United States
UCLA Department of Medicine
Los Angeles, California, 90095
United States
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, 80218
United States
AdventHealth Celebration
Celebration, Florida, 34747
United States
Florida Cancer Specialists
Sarasota, Florida, 34232
United States
University of Iowa Hospitals & Clinics
Iowa City, Iowa, 52242
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
United States
Washington University School of Medicine
Saint Louis, Missouri, 63110
United States
OU Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
United States
SCRI - Oncology Partners
Nashville, Tennessee, 37203
United States
University of Wisconsin (Carbone Cancer Center)
Madison, Wisconsin, 53792
United States

Collaborators and Investigators

Sponsor: Kura Oncology, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-18
Study Completion Date2027-04

Study Record Updates

Study Start Date2023-10-18
Study Completion Date2027-04

Terms related to this study

Keywords Provided by Researchers

  • HRAS
  • KRAS
  • NRAS
  • Farnesyl transferase inhibitor (FTI)
  • Tyrosine Kinase inhibitor (TKI)
  • Phase 1
  • KRAS G12C inhibitor
  • NSCLC
  • ccRCC
  • RCC
  • PDAC
  • CRC

Additional Relevant MeSH Terms

  • Solid Tumors with HRAS Alterations
  • Non Small Cell Lung Cancer (NSCLC)
  • Colorectal Cancer (CRC)
  • Pancreatic Ductal Adenocarcinoma (PDAC)
  • Clear Cell Renal Cell Carcinoma (ccRCC)
  • Renal Cell Carcinoma (Kidney Cancer)