KO-2806 Monotherapy and Combination Therapies in Advanced Solid Tumors

Conditions

• Clear Cell Renal Cell Carcinoma (ccRCC)
• Colorectal Cancer (CRC)
• Non Clear Cell Renal Cell Carcinoma (nccRCC)
• Non Small Cell Lung Cancer (NSCLC)
• Pancreatic Ductal Adenocarcinoma (PDAC)
• Renal Cell Carcinoma (Kidney Cancer)
• Solid Tumors With HRAS Alterations

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Darlifarnib — DRUG
  Oral administration
• Cabozantinib — DRUG
  Oral administration
• Adagrasib — DRUG
  Oral administration

Study Details

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.

Key Dates

Start date

Oct 18, 2023

Status verified

Jun 2026

Primary completion

Jan 31, 2027

Completion

Apr 30, 2027

Study Design

Enrollment

300 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Arm #1: RAS-altered advanced solid tumors, monotherapy (escalation phase)
  Patients with advanced solid tumors and the following: * 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 for NSCLC or CRC * KRAS-mutant and/or amplified PDAC
• Experimental: Arm #2: Advanced or metastatic RCC, combination therapy (escalation phase)
  Patients who have received at least 1 prior systemic therapy with immuno-oncology (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
• Experimental: Arm #3: Advanced or metastatic NSCLC, CRC, or PDAC, combination therapy (escalation phase)
  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
• Experimental: Arm #4: Advanced or metastatic ccRCC, combination therapy (expansion phase)
  Patients must be cabozantinib-naïve and have received at least 1 prior systemic therapy with IO-based treatment for locally advanced or metastatic ccRCC
• Experimental: Arm #5: Advanced or metastatic ccRCC, monotherapy (expansion phase)
  Patients must be cabozantinib-naïve and have received at least 1 prior systemic therapy with IO-based treatment for locally advanced or metastatic ccRCC
• Experimental: Arm #6: Advanced or metastatic ccRCC, cabozantinib rollover to combination therapy (expansion phase)
  Patients must be cabozantinib-naïve and have received at least 1 prior systemic therapy with IO-based treatment for locally advanced or metastatic ccRCC
• Experimental: Arm #7: Advanced or metastatic NSCLC, combination therapy (expansion phase)
  Patients with KRAS G12C-mutant locally advanced or metastatic NSCLC who have received at least 1 prior systemic therapy including available approved standard of care treatments

Primary Outcome Measure

Rate of dose-limiting toxicities (DLTs) [ Time Frame: DLTs will be evaluated during the first 28 days of KO-2806 treatment (dose escalation) ]

Central Contacts

• Kura Medical Information
  844-KURAONC (844-587-2662)
  [email protected]

Locations (22)

Find similar trials in Phoenix, AZ

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