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KO-2806 Monotherapy and Combination Therapies in Advanced Solid Tumors (FIT-001)

K

Kura Oncology

Status and phase

Enrolling
Phase 1

Conditions

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

Treatments

Drug: Cabozantinib
Drug: Adagrasib
Drug: KO-2806

Study type

Interventional

Funder types

Industry

Identifiers

NCT06026410
KO-2806-001

Details and patient eligibility

About

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.

Enrollment

270 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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
    • 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.

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

270 participants in 3 patient groups

Arm #1: RAS-altered advanced solid tumors
Experimental group
Description:
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
Treatment:
Drug: KO-2806
Arm #2: Advanced or metastatic RCC
Experimental group
Description:
Patients who have received at least 1 prior systemic therapy with IO-based treatment for locally advanced or metastatic RCC
Treatment:
Drug: KO-2806
Drug: Cabozantinib
Arm #3: Advanced or metastatic NSCLC, CRC, or PDAC
Experimental group
Description:
Patients with KRAS G12C-mutant locally advanced or metastatic NSCLC, CRC, or PDAC who have received at least 1 prior systemic therapy for advanced or metastatic disease
Treatment:
Drug: KO-2806
Drug: Adagrasib

Trial contacts and locations

26

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Central trial contact

Clinical Operations

Data sourced from clinicaltrials.gov

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