A Phase 1 interventional study of ALTA2618 in Cancer, Breast Cancer and Endometrial Cancer, sponsored by Alterome Therapeutics, Inc.. Active, not recruiting at 31 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-15.
Sponsored by Alterome Therapeutics, Inc. · Phase 1, Interventional, and Treatment
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.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's planned enrollment of 110 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Alterome Therapeutics, Inc. is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other inclusion/exclusion criteria may apply.
ALTA2618 will be administered continuously at a protocol-defined dose based on cohort assignment
Drug: ALTA2618
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
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
This study is active, not recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Alterome Therapeutics, Inc.