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AKT Inhibitor

ALTA2618 for Cancer

Phase 1
Recruiting
Research Sponsored by Alterome Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Unresectable or metastatic disease
Histologically confirmed diagnosis of a solid tumor malignancy harboring AKT1 E17K mutation identified through molecular testing with a Clinical Laboratory Improvement Amendments-certified diagnostic
Must not have
Prior treatment with PI3K and/or mTOR inhibitors
Patients known to have KRAS, NRAS, HRAS, or BRAF genomic alterations in their tumor
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 39 months
Awards & highlights

Summary

This trial aims to understand how safe and well-tolerated ALTA2618 is in adults with a specific type of advanced solid tumors called AKT1 E17K-mutant tumors.

Who is the study for?
This trial is for adults with advanced solid tumors that have a specific mutation called AKT1 E17K. It's open to those who haven't had success with previous treatments or for whom no suitable alternatives exist.
What is being tested?
The study is testing the safety and how well people can tolerate ALTA2618, which is a new medication aimed at targeting certain mutations in tumor cells.
What are the potential side effects?
Specific side effects of ALTA2618 are not listed, but common ones for cancer medications may include nausea, fatigue, skin reactions, and changes in blood counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer cannot be removed by surgery or has spread.
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My cancer has the AKT1 E17K mutation.
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I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been treated with PI3K or mTOR inhibitors before.
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My tumor has a KRAS, NRAS, HRAS, or BRAF mutation.
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I cannot swallow or absorb pills due to a medical condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 39 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 39 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adverse Events
Dose Limiting Toxicities
Secondary study objectives
Area Under Plasma Concentration Time Curve During the Dosing Interval (AUCt)
Duration of Response (DOR)
Maximum Observed Plasma Concentration (Cmax)
+5 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: ALTA2618Experimental Treatment1 Intervention
ALTA2618 will be administered continuously at a protocol-defined dose based on cohort assignment

Find a Location

Who is running the clinical trial?

Alterome Therapeutics, Inc.Lead Sponsor
Study Medical DirectorStudy DirectorAlterome Therapeutics
~73 spots leftby Dec 2026
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