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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06533059




Registration number
NCT06533059
Ethics application status
Date submitted
25/07/2024
Date registered
1/08/2024
Date last updated
13/04/2025

Titles & IDs
Public title
A Study to Learn About Study Medicine ALTA2618 in Adults With AKT1 E17K-Mutant Solid Tumors
Scientific title
AKTive-001: A Phase 1/1b Multiple Cohort Trial of ALTA2618 in Patients With Advanced Solid Tumors With AKT1 E17K Mutation
Secondary ID [1] 0 0
2618-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 0 0
Breast Cancer 0 0
Endometrial Cancer 0 0
Metastatic Cancer 0 0
Advanced Solid Tumor 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ALTA2618

Experimental: ALTA2618 - ALTA2618 will be administered continuously at a protocol-defined dose based on cohort assignment


Treatment: Drugs: ALTA2618
Oral ALTA2618 tablets will be administered at protocol-defined dose
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Adverse Events
Assessment method [1] 0 0
Number of participants that experience treatment-emergent adverse events (TEAEs).
Timepoint [1] 0 0
Up to 39 months
Primary outcome [2] 0 0
Dose Limiting Toxicities
Assessment method [2] 0 0
Number of participants with Dose Limiting Toxicities (DLTs).
Timepoint [2] 0 0
21 days
Secondary outcome [1] 0 0
Maximum Observed Plasma Concentration (Cmax)
Assessment method [1] 0 0
Cmax
Timepoint [1] 0 0
Cycle 1 (each cycle is 21 days) Day 1 (or Lead-in) and Day 8: Predose and up to 24 hours postdose
Secondary outcome [2] 0 0
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Assessment method [2] 0 0
Tmax
Timepoint [2] 0 0
Cycle 1 (each cycle is 21 days) Day 1 (or Lead-in) and Day 8: Predose and up to 24 hours postdose
Secondary outcome [3] 0 0
Area Under Plasma Concentration Time Curve During the Dosing Interval (AUCt)
Assessment method [3] 0 0
AUCt
Timepoint [3] 0 0
Cycle 1 (each cycle is 21 days) Day 1 (or Lead-in) and Day 8: Predose and up to 24 hours postdose
Secondary outcome [4] 0 0
Terminal Half-Life (t1/2)
Assessment method [4] 0 0
t1/2
Timepoint [4] 0 0
Cycle 1 (each cycle is 21 days) Lead-in phase: Predose and up to 72 hours postdose
Secondary outcome [5] 0 0
Overall Response Rate (ORR)
Assessment method [5] 0 0
Assess per RECIST 1.1
Timepoint [5] 0 0
Up to 39 months
Secondary outcome [6] 0 0
Duration of Response (DOR)
Assessment method [6] 0 0
Assess per RECIST 1.1
Timepoint [6] 0 0
Up to 39 months
Secondary outcome [7] 0 0
Progression-Free Survival (PFS)
Assessment method [7] 0 0
Assess per RECIST 1.1
Timepoint [7] 0 0
Up to 39 months
Secondary outcome [8] 0 0
Overall Survival (OS)
Assessment method [8] 0 0
Assess per RECIST 1.1
Timepoint [8] 0 0
Up to 39 months

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/08/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
29/12/2027
Actual
Sample size
Target
110
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC,WA
Recruitment hospital [1] 0 0
Research Site - Malvern
Recruitment hospital [2] 0 0
Research Site - Nedlands
Recruitment postcode(s) [1] 0 0
3144 - Malvern
Recruitment postcode(s) [2] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
Missouri
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
Tennessee
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas
Country [9] 0 0
United States of America
State/province [9] 0 0
Virginia
Country [10] 0 0
Japan
State/province [10] 0 0
Kyoto
Country [11] 0 0
Japan
State/province [11] 0 0
Shizuoka
Country [12] 0 0
Japan
State/province [12] 0 0
Tokyo
Country [13] 0 0
Korea, Republic of
State/province [13] 0 0
Seoul
Country [14] 0 0
Spain
State/province [14] 0 0
Barcelona
Country [15] 0 0
Spain
State/province [15] 0 0
Madrid
Country [16] 0 0
Taiwan
State/province [16] 0 0
Taipei

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Alterome Therapeutics, Inc.
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Study Medical Director
Address 0 0
Alterome Therapeutics
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Alterome Clinical Trial Contact Center
Address 0 0
Country 0 0
Phone 0 0
619-768-8189
Email 0 0
clinical.trials@alterome.com
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06533059