The purpose of this study is to characterize the safety and tolerability of ALTA3263 in adults with advanced solid tumors with KRAS mutations.
This is an open-label, multicenter, Phase 1/1b study of ALTA3263, an orally bioavailable KRAS isoform-selective inhibitor that inhibits multiple mutant forms of KRAS, in adults with advanced solid tumor malignancies with KRAS mutations. This study will evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary clinical activity of ALTA3263 as a monotherapy and as a combination regimen. The study consists of two parts: Part 1 - Dose Escalation and Part 1b - Dose Expansion.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
188
Research Site
Orlando, Florida, United States
RECRUITINGResearch Site
Boston, Massachusetts, United States
RECRUITINGResearch Site
Boston, Massachusetts, United States
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 15: 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 15: 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 15: 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 48 hours postdose
Objective 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
New York, New York, United States
RECRUITINGResearch Site
Nashville, Tennessee, United States
RECRUITINGResearch Site
Houston, Texas, United States
RECRUITINGResearch Site
San Antonio, Texas, United States
RECRUITINGResearch Site
Fairfax, Virginia, United States
RECRUITINGProgression-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