RecruitingPhase 1

KO-2806 Monotherapy and Combination Therapies in 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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests KO-2806 in people for the first time, both alone and with other cancer drugs. It will study doses in adults with advanced solid tumors. Some groups will receive cabozantinib alone or switch from cabozantinib to a drug combination.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You must be at least 18 and have an advanced solid tumor confirmed by testing tissue or cells.
  • Group 1: Standard treatments must have stopped working or not worked. Your cancer must have certain changes in the HRAS, KRAS, or NRAS genes, or extra HRAS activity. The allowed changes depend on whether you have head and neck, lung, colon or rectal, pancreatic, or another solid cancer.
  • Group 2: You must have advanced kidney cancer. For mostly clear cell cancer, you must have had at least one drug treatment that included immunotherapy, which helps the immune system fight cancer. For non-clear cell cancer, prior treatment is not required.
  • Groups 3 and 7: You must have advanced cancer with a KRAS G12C gene change and at least one prior drug treatment, including available approved standard treatments. Group 3 allows certain lung, colon or rectal, or pancreatic cancers. Group 7 allows only non-small cell lung cancer.
  • Groups 4–6: You must have advanced clear cell kidney cancer and never have taken cabozantinib. You must have had 1–3 prior cancer drug treatments, including immunotherapy.
  • Your cancer must be measurable using the study's rules.
  • Your ability to do daily tasks must score at least 70 on the Karnofsky scale, with no major decline in the past 2 weeks.
  • Your liver, kidneys, hormone system, and blood tests must meet study limits. Other study rules may apply.

Who can't join

  • You had cancer treatment too close to the first study dose: within 14 days or the time for five half-lives of the drug, whichever is shorter. A half-life is the time it takes the body to remove half a drug. You also cannot have had a farnesyltransferase inhibitor (FTI) or HRAS-blocking drug before.
  • You had major surgery within 28 days before the first study dose and have not fully recovered. Small local procedures do not count. Side effects from past treatment, other than hair loss, must have returned to your usual baseline before consent.
  • You have pressure on the spinal cord, cancer in the lining around the brain or spinal cord, or active cancer spread to the brain or spinal cord.
  • You have had an autoimmune disease, where the immune system attacks the body, or an inflammatory disorder within the past 5 years. Some exceptions apply.
  • You have an active, uncontrolled bacterial, viral, or fungal infection needing treatment that works throughout the body.
  • You cannot swallow, or you have stomach or bowel problems that could greatly affect how your body takes in the study drugs.
  • Your heart or blood vessels do not meet study limits. This includes treatment for unstable chest pain, a heart attack, or a stroke in the past 6 months; a heart rhythm test result called QTcF of 470 milliseconds or more; or class II or worse heart failure.
  • You have had another invasive cancer within 2 years. Other study rules may also exclude you.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * At least 18 years of age. * Histologically or cytologically confirmed advanced solid tumors * Arm #1 (KO-2806 monotherapy): Patients who have progressed on, or are refractory to, standard of care (SOC) treatments with advanced solid tumors, specifically: 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 who have received at least 1 prior systemic therapy including available approved SOC treatments for KRAS G12C-mutant locally advanced or metastatic NSCLC, CRC, or PDAC. * Arm #4 (Combination): Patients must be cabozantinib-naïve and have received at least 1 prior systemic therapy with IO-based treatment for locally advanced or metastatic ccRCC, but no more than 3 prior systemic anticancer therapies. * Arm #5 (Cabozantinib monotherapy): Patients must be cabozantinib-naïve and have received at least 1 prior systemic therapy with IO-based treatment for locally advanced or metastatic ccRCC, but no more than 3 prior systemic anticancer therapies. * Arm #6 (Cabozantinib rollover to combination): Patients must be cabozantinib-naïve and have received at least 1 prior systemic therapy with IO-based treatment for locally advanced or metastatic ccRCC, but no more than 3 prior systemic anticancer therapies. * Arm #7 (Combination): Patients who have received at least 1 prior systemic therapy including available approved SOC treatments for KRAS G12C-mutant locally 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: * Any use of anticancer therapy within 14 days or 5 half-lives (whichever is shorter) of Cycle 1 Day 1. * 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 cerebrovascular 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 sites (22)

AZ

CA

CO

FL

IA

MA

MI

MN

MO

NJ

OH

OK

PA

TN

TX

WI