KO-2806 in Adult Patients With Advanced Solid Tumors

What is the Purpose of this Study?

The purpose of this study is to determine the highest tolerable dose of an investigational drug called KO-2806 in combination with an approved therapy called cabozantinib, in people with renal cell carcinoma (RCC) of predominantly clear cell type (ccRCC) who have been treated with at least 1 prior line of immune-therapy. Researchers also aim to determine whether KO-2806 has an antitumor effect (reduces the size of the tumor and slows down the growth of cancer) in combination with cabozantinib. Increased activity of some key proteins in cells is important for maintaining the cancerous properties of tumor cells. KO-2806 targets certain proteins involved in the patient’s cancer and limits their activity.

Eligibility

* 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

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): Must have received at least 1 prior systemic therapy with IO-based treatment for locally advanced or metastatic RCC with predominantly clear cell subtype
* Arm #3 (Combination): Must have KRAS G12C-mutant locally advanced or metastatic NSCLC and have received at least 1 prior systemic therapy for 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.

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.

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Where can I participate?

CS Cancer at Cedars-Sinai Medical Center : Shannon Cyhan

More about this Clinical Trial

What is the full name of this clinical trial?

KO-2806-001: 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

Study Details

Disease Type/Condition

Cervix, Kidney, Lung, Other Female Genital, Pancreas, Rectum, Small Intestine

Principal Investigator

Hendifar, Andrew

Co-Investigators

Jun Gong, Justin Moyers, Karen Reckamp, Navid Hafez, Omid Hamid, Robert Figlin

Age Group

Adult

Phase

IRB Number

STUDY00003057

ClinicalTrials.gov ID

NCT06026410

Key Eligibility

ClinicalTrials.gov

How do I learn more about this study?

Name

Shannon Cyhan

Shannon.Cyhan@cshs.org