At a glance
ClinicalIndex Comparison RecordPhase 1Recruiting· 300 target
Drug / intervention
Darlifarnib +2 moredrug
Likely dose
Not stated in record
Key inclusion· 10
- ✓Age at least 18 years
- ✓Histologically or cytologically confirmed advanced solid tumors
- ✓Measurable disease by RECIST v1.1
- ✓Karnofsky Performance Status 70 or higher
Key exclusion· 10
- ✕CNS metastases including spinal cord compression, leptomeningeal disease, or clinically active CNS metastases
- ✕Prior treatment with FTI or HRAS inhibitor
- ✕Major surgery within 28 days prior to Cycle 1 Day 1 without complete recovery
- ✕Toxicity from prior therapy not resolved to baseline
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating Darlifarnib, Cabozantinib, and 1 other intervention for Solid Tumors With HRAS Alterations and 6 related conditions. Currently recruiting, targeting 300 participants across 38 sites in 5 countries.
Signals
Enrolling ahead of pace
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSolid Tumors With HRAS Alterations, Non Small Cell Lung Cancer (NSCLC), Colorectal Cancer (CRC), Pancreatic Ductal Adenocarcinoma (PDAC), Clear Cell Renal Cell Carcinoma (ccRCC), Renal Cell Carcinoma (Kidney Cancer), Non Clear Cell Renal Cell Carcinoma (nccRCC)
CountriesFrance, Germany, Italy, Spain, United States
CollaboratorsMirati Therapeutics Inc.
Timeline
Phase 1Recruiting
2024202520262027
First PostedSep 2023
Enrollment StartOct 2023
TodayJul 2026
Primary CompletionJan 2027
Study CompletionApr 2027
First PostedSep 7, 2023
Enrollment StartOct 18, 2023
Primary CompletionJan 1, 2027
Study CompletionApr 1, 2027
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 2.8 years agoPrimary completion in 6 months
Interventions
Darlifarnibdrug
Oral administration
Cabozantinibdrug
Oral administration
Adagrasibdrug
Oral administration