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Investigating ALTA2618 for adults with specific cancer mutations

AKTive-001: A Phase 1/1b Multiple Cohort Trial of ALTA2618 in Patients With Advanced Solid Tumors With AKT1 E17K Mutation

PHASE1 · Alterome Therapeutics, Inc. · NCT06533059

This study is testing a new oral medication called ALTA2618 to see if it is safe and effective for adults with advanced cancer that has a specific mutation.

Quick facts

PhasePHASE1
Study typeInterventional
Enrollment110 (estimated)
Ages18 Years and up
SexAll
SponsorAlterome Therapeutics, Inc. (industry)
Locations51 sites (La Jolla, California and 50 other locations)
Trial IDNCT06533059 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and tolerability of ALTA2618, an oral AKT1 E17K inhibitor, in adults with advanced solid tumors that have the AKT1 E17K mutation. It is an open-label, multicenter Phase 1/1b study designed to determine the best dose while assessing pharmacokinetics and preliminary clinical activity. The study consists of two parts: a dose escalation phase and a dose expansion phase, focusing on patients who have progressed on or are intolerant to prior therapies.

Who should consider this trial

Good fit: Ideal candidates are adults with unresectable or metastatic solid tumors harboring the AKT1 E17K mutation who have not responded to or cannot tolerate standard therapies.

Not a fit: Patients with prior treatment using PI3K or mTOR inhibitors or those with specific genomic alterations like KRAS, NRAS, HRAS, or BRAF mutations may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a targeted therapy option for patients with AKT1 E17K-mutant solid tumors.

How similar studies have performed: Other studies targeting specific mutations in cancer have shown promise, suggesting potential for success with this approach.

Eligibility criteria

Show full inclusion / exclusion 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:

* 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

Other inclusion/exclusion criteria may apply.

Where this trial is running

La Jolla, California and 50 other locations

+1 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Cancer, Breast Cancer, Endometrial Cancer, Metastatic Cancer, Advanced Solid Tumor, AKT1 E17K, Breast cancer, Breast carcinoma

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.