Advanced solid tumors with AKT1 E17K mutation
Conditions
Interventions
Oral ALTA2618 tablets will be administered once daily.
Sponsors
Nakashima Michiyo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Histologically confirmed diagnosis of a solid tumor malignancy harboring AKT1 E17K mutation identified through molecular testing (NGS- or PCR-based) with a Clinical Laboratory Improvement Amendments-certified (or equivalent) diagnostic test. - Unresectable or metastatic disease. - Progressed on, intolerant to, or declined prior standard-of-care therapy (including targeted therapy, if applicable) appropriate to tumor type and stage. - Evaluable or measurable disease per RECIST v1.1. - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. - Adequate organ function.
Exclusion criteria
Exclusion criteria: - Prior treatment with PI3K and/or mTOR inhibitors. - Patients known to have KRAS, NRAS, HRAS, or BRAF genomic alterations in their tumor. - Known condition that prohibits ability to swallow or absorb an oral medication.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Number of participants that experience treatment-emergent adverse events (TEAEs) - Number of participants with Dose Limiting Toxicities (DLTs) | — |
Secondary
| Measure | Time frame |
|---|---|
| - Maximum Observed Plasma Concentration (Cmax) - Time to Reach Maximum Observed Plasma Concentration (Tmax) - Area Under Plasma Concentration Time Curve During the Dosing Interval (AUCt) - Terminal Half-Life (t1/2) - Overall Response Rate (ORR), assess per RECIST 1.1 - Duration of Response (DOR), assess per RECIST 1.1 - Progression-Free Survival (PFS), assess per RECIST 1.1 - Overall Survival (OS), assess per RECIST 1.1 | — |
Countries
Australia, France, Japan, South Korea, Spain, Taiwan, UK, US
Contacts
Public ContactMichiyo Nakashima
Syneos Health Japan K.K.
Outcome results
None listed