Kidney Cancer Clinical Trial

KO-2806 Monotherapy and Combination Therapies in Advanced Solid Tumors

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.

View Eligibility Criteria

Eligibility 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): 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.
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.

Study is for people with:

Kidney Cancer

Phase:

Phase 1

Estimated Enrollment:

270

Study ID:

NCT06026410

Recruitment Status:

Recruiting

Sponsor:

Kura Oncology, Inc.

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There are 10 Locations for this study

See Locations Near You

University of Southern California
Los Angeles California, 90033, United States More Info
Xiomara Menendez, RN
Contact
323-865-3000
[email protected]
UCLA Department of Medicine
Los Angeles California, 90095, United States More Info
Christopher Lim
Contact
310-633-8400
[email protected]
Sarah Cannon Research Institute at HealthONE
Denver Colorado, 80218, United States More Info
AdventHealth Celebration
Celebration Florida, 34747, United States More Info
Amy Whitaker
Contact
[email protected]
Florida Cancer Specialists
Sarasota Florida, 34232, United States More Info
Nancy Olsen
Contact
[email protected]
Dana-Farber Cancer Institute
Boston Massachusetts, 02215, United States More Info
Emily McClure, RN
Contact
857-215-0180
[email protected]
Washington University School of Medicine
Saint Louis Missouri, 63110, United States More Info
Jessica Ley
Contact
314-747-8092
[email protected]
OU Stephenson Cancer Center
Oklahoma City Oklahoma, 73104, United States More Info
Christina Caldwell
Contact
405-271-8001
[email protected]
SCRI - Oncology Partners
Nashville Tennessee, 37203, United States More Info
Contact
844-482-4812
University of Wisconsin (Carbone Cancer Center)
Madison Wisconsin, 53792, United States More Info
UW Carbone Cancer Center - Cancer Connect
Contact
800-622-8922
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Kidney Cancer

Phase:

Phase 1

Estimated Enrollment:

270

Study ID:

NCT06026410

Recruitment Status:

Recruiting

Sponsor:


Kura Oncology, Inc.

How clear is this clinincal trial information?

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