A Phase 1, first-in-human, multicenter, open-label study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of KO-2806 administered as monotherapy and in combination therapy in adult patients with advanced solid tumors.

Principal Investigator

Dott.ssa Vanesa Gregorc

Contact Information for Access

Phase

FASE I (FIH)

Status

ATTIVO

Objective of the study

1. To evaluate the safety and tolerability of KO-2806 administered as monotherapy and in combination therapy in patients with advanced solid tumors (escalation phases).

2. To determine the maximum tolerated dose (MTD)/highest protocol-defined dose (HPDD) and/or the optimal biologically active dose (OBAD) of KO-2806 administered as monotherapy and in combination therapy in patients with advanced solid tumors (dose-escalation phases).

3. Determine the recommended Phase 2 dose (RP2D) of KO-2806 in combination therapy for patients with advanced solid tumors (expansion phase).

4. Evaluate the antitumor activity of KO-2806 in combination therapy in patients with advanced solid tumors (expansion phase).

Multiple Conditions:
Lung
Colon
Kidney

ClinicalTrials.gov ID NCT06026410
Sponsor: Kura Oncology, Inc.

Pathologies

Kidney cancer (renal cancer)

Medication

Darlifarnib (KO-2806, farnesyl transferase inhibitor), Adagrasib, Cabozantinib

Who is eligible to participate in the study?

Patients who are 18 years of age or older and who meet the study’s eligibility criteria may participate in this study.
Patients with renal cell carcinoma who have received at least one prior course of immunotherapy, no more than three courses of chemotherapy, and who have not previously received cabozantinib.

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KO-2806-001