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NCT06026410 | RECRUITING | Solid Tumors With HRAS Alterations

KO-2806 Monotherapy and Combination Therapies in Advanced Solid Tumors
Sponsor:

Kura Oncology, Inc.

Brief Summary:

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.

Condition or disease

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)

Intervention/treatment

Darlifarnib

Cabozantinib

Adagrasib

Phase

PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 270 participants
Masking : NONE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2023-10-18
Estimated Primary Completion Date : 2027-01
Estimated Study Completion Date : 2027-04

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * At least 18 years of age.
  • * Histologically or cytologically confirmed advanced solid tumors
  • * 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
  • * 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 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.
  • * 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
  • * Ongoing treatment with certain anticancer agents.
  • * 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 cerebro-vascular 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.
KO-2806 Monotherapy and Combination Therapies in Advanced Solid Tumors

Location Details

NCT06026410

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Arizona

Mayo Clinic Comprehensive Cancer Center

Phoenix, arizona, United States, 85054

RECRUITING

United States, California

University of Southern California

Los Angeles, California, United States, 90033

RECRUITING

United States, California

Cedars-Sinai Medical Center

Los Angeles, California, United States, 90048

RECRUITING

United States, California

UCLA Department of Medicine

Los Angeles, California, United States, 90095

RECRUITING

United States, Colorado

Sarah Cannon Research Institute at HealthONE

Denver, Colorado, United States, 80218

RECRUITING

United States, Florida

AdventHealth Celebration

Celebration, florida, United States, 34747

RECRUITING

United States, Florida

Mayo Clinic Comprehensive Cancer Center

Jacksonville, florida, United States, 32224

RECRUITING

United States, Florida

Florida Cancer Specialists

Sarasota, florida, United States, 34232

RECRUITING

United States, Iowa

University of Iowa Hospitals & Clinics

Iowa City, Iowa, United States, 52242

RECRUITING

United States, Massachusetts

Dana-Farber Cancer Institute

Boston, Massachusetts, United States, 02215

RECRUITING

United States, road cancer

Henry Ford Health System

Detroit, road cancer, United States, 48202

RECRUITING

United States, Minnesota

Mayo Clinic Comprehensive Cancer Center

Rochester, Minnesota, United States, 55905

RECRUITING

United States, Missouri

Washington University School of Medicine

St Louis, Missouri, United States, 63110

RECRUITING

United States, New Jersey

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States, 08901

RECRUITING

United States, Oklahola

OU Stephenson Cancer Center

Ololama City, Okholohan, United States, 73104

RECRUITING

United States, Pennsylvania

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States, 15232

RECRUITING

United States, Tennessee

SCRI - Oncology Partners

Nashville, Tennessee, United States, 37203

RECRUITING

United States, Texas

UT Southwestern Simmons Cancer Center

dallas, Texas, United States, 75235

RECRUITING

United States, Texas

MD Anderson Cancer Center

Houston, Texas, United States, 77030

RECRUITING

United States, Wisconsin

University of Wisconsin (Carbone Cancer Center)

Madison, Wisconsin, United States, 53792

RECRUITING

France,

Medical oncology - Pitié-Salpêtrière

Paris, France, 75013

RECRUITING

France,

Georges Pompidou European Hospital

Paris, France, 75015

RECRUITING

France,

Toulouse University Cancer Institute - Oncopole

Toulouse, France, 31059

RECRUITING

Italy,

University Hospital Policlinico Sant'Orsola Malpighi IRCCS

Bologna, Italy, 40138

RECRUITING

Italy,

Piedmont Foundation for Oncology - IRCCs Candiolo

Candiolo, Italy, 10060

RECRUITING

Italy,

National Cancer Institute IRCCS

Napoli, Italy, 80131

RECRUITING

Italy,

Camplus Humanitas University

Rozzano, Italy, 20089

RECRUITING

Italy,

AOU Verona - Clinical Research Center of Verona

Verona, Italy, 37134

RECRUITING

Spain,

Vall d'Hebron University Hospital

Barcelona, Spain, 08035

RECRUITING

Spain,

Santa Creu and Sant Pau Hospital

Barcelona, Spain, 08041

RECRUITING

Spain,

Hospital HM Sanchinarro START Madrid-CIOCC

Madrid, Spain, 28050

RECRUITING

Spain,

Virgen del Rocío University Hospital

Seville, Spain, 41013