NCT06533059Active, not recruitingPhase 1
A Study to Learn About Study Medicine ALTA2618 in Adults With AKT1 E17K-Mutant Solid Tumors
AKTive-001: A Phase 1/1b Multiple Cohort Trial of ALTA2618 in Patients With Advanced Solid Tumors With AKT1 E17K Mutation
Source: ClinicalTrials.gov · Last updated 15 Jul 2026
Brief summary (registry, in English)
The purpose of this study is to characterize the safety and tolerability of ALTA2618 in adults with AKT1 E17K-mutant advanced solid tumors.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 110 (estimated)
- First submitted
- 25 Jul 2024
- Start date
- 22 Aug 2024
- Primary completion date
- 29 Dec 2026
- Lead sponsor
- Alterome Therapeutics, Inc.
- Diseases
- Prostate cancer, Triple-negative breast cancer, Endometrial cancer, Cervical cancer, Ovarian cancer
- NCT number
- NCT06533059
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 110
- From 22 Aug 2024 to the primary completion date, 29 Dec 2026
- 26 sites in 8 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior treatment with PI3K and/or mTOR inhibitors
Other illness
- Known condition that prohibits ability to swallow or absorb an oral medication
- Other inclusion/exclusion criteria may apply.
Other
- Patients known to have KRAS, NRAS, HRAS, or BRAF genomic alterations in their tumor
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (26)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.