The purpose of this study is to characterize the safety and tolerability of ALTA2618 in adults with AKT1 E17K-mutant advanced solid tumors.
This is an open-label, multicenter, Phase 1/1b study of ALTA2618, a mutant-selective and orally bioavailable AKT1 E17K inhibitor, in adults with AKT1 E17K-mutant solid tumors. This study will evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary clinical activity of ALTA2618, and aims to find the best dose. The study consists of two parts: Part 1 - Dose Escalation and Part 1b - Dose Expansion.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
110
Oral ALTA2618 tablets will be administered at protocol-defined dose
Adverse Events
Number of participants that experience treatment-emergent adverse events (TEAEs).
Time frame: Up to 39 months
Dose Limiting Toxicities
Number of participants with Dose Limiting Toxicities (DLTs).
Time frame: 21 days
Maximum Observed Plasma Concentration (Cmax)
Cmax
Time frame: Cycle 1 (each cycle is 21 days) Day 1 (or Lead-in) and Day 8: Predose and up to 24 hours postdose
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Tmax
Time frame: Cycle 1 (each cycle is 21 days) Day 1 (or Lead-in) and Day 8: Predose and up to 24 hours postdose
Area Under Plasma Concentration Time Curve During the Dosing Interval (AUCt)
AUCt
Time frame: Cycle 1 (each cycle is 21 days) Day 1 (or Lead-in) and Day 8: Predose and up to 24 hours postdose
Terminal Half-Life (t1/2)
t1/2
Time frame: Cycle 1 (each cycle is 21 days) Lead-in phase: Predose and up to 72 hours postdose
Overall Response Rate (ORR)
Assess per RECIST 1.1
Time frame: Up to 39 months
Duration of Response (DOR)
Assess per RECIST 1.1
Time frame: Up to 39 months
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Research Site
La Jolla, California, United States
RECRUITINGResearch Site
Los Angeles, California, United States
RECRUITINGResearch Site
Denver, Colorado, United States
RECRUITINGResearch Site
Sarasota, Florida, United States
RECRUITINGResearch Site
Atlanta, Georgia, United States
RECRUITINGResearch Site
Boston, Massachusetts, United States
RECRUITINGResearch Site
Boston, Massachusetts, United States
RECRUITINGResearch Site
St Louis, Missouri, United States
RECRUITINGResearch Site
Mineola, New York, United States
RECRUITINGResearch Site
New York, New York, United States
RECRUITING...and 41 more locations
Progression-Free Survival (PFS)
Assess per RECIST 1.1
Time frame: Up to 39 months
Overall Survival (OS)
Assess per RECIST 1.1
Time frame: Up to 39 months