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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
5/02/2025

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
Timepoint [1] 0 0
Up to 39 months
Primary outcome [2] 0 0
Dose Limiting Toxicities
Timepoint [2] 0 0
21 days
Secondary outcome [1] 0 0
Maximum Observed Plasma Concentration (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)
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)
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)
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)
Timepoint [5] 0 0
Up to 39 months
Secondary outcome [6] 0 0
Duration of Response (DOR)
Timepoint [6] 0 0
Up to 39 months
Secondary outcome [7] 0 0
Progression-Free Survival (PFS)
Timepoint [7] 0 0
Up to 39 months
Secondary outcome [8] 0 0
Overall Survival (OS)
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)
WA
Recruitment hospital [1] 0 0
Research Site - Nedlands
Recruitment postcode(s) [1] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Colorado
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Massachusetts
Country [4] 0 0
United States of America
State/province [4] 0 0
Missouri
Country [5] 0 0
United States of America
State/province [5] 0 0
Tennessee
Country [6] 0 0
United States of America
State/province [6] 0 0
Texas
Country [7] 0 0
United States of America
State/province [7] 0 0
Virginia

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

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to characterize the safety and tolerability of ALTA2618 in adults with AKT1 E17K-mutant advanced solid tumors.
Trial website
https://clinicaltrials.gov/study/NCT06533059
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Study Medical Director
Address 0 0
Alterome Therapeutics
Country 0 0
Phone 0 0
Fax 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
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06533059