KO-2806 Monotherapy and Combination Therapies in Advanced Solid Tumors

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.

Conditions

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)

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Study Overview

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Study Details

Study overview

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.

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

KO-2806 Monotherapy and Combination Therapies in Advanced Solid Tumors

Condition
Solid Tumors with HRAS Alterations
Intervention / Treatment

-

Contacts and Locations

Los Angeles

University of Southern California, Los Angeles, California, United States, 90033

Los Angeles

Cedars-Sinai Medical Center, Los Angeles, California, United States, 90048

Los Angeles

UCLA Department of Medicine, Los Angeles, California, United States, 90095

Denver

Sarah Cannon Research Institute at HealthONE, Denver, Colorado, United States, 80218

Celebration

AdventHealth Celebration, Celebration, Florida, United States, 34747

Sarasota

Florida Cancer Specialists, Sarasota, Florida, United States, 34232

Iowa City

University of Iowa Hospitals & Clinics, Iowa City, Iowa, United States, 52242

Boston

Dana-Farber Cancer Institute, Boston, Massachusetts, United States, 02215

Saint Louis

Washington University School of Medicine, Saint Louis, Missouri, United States, 63110

Oklahoma City

OU Stephenson Cancer Center, Oklahoma City, Oklahoma, United States, 73104

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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): Must have received at least 1 prior systemic therapy with IO-based treatment for locally advanced or metastatic RCC
  • * 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
  • * 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Kura Oncology, Inc.,

Study Record Dates

2027-04