A Study to Learn About Study Medicine ALTA2618 in Adults With AKT1 E17K-Mutant Solid Tumors
Conditions
Cancer, Breast Cancer, Endometrial Cancer, Metastatic Cancer, Advanced Solid TumorDrugs
ALTA2618Summary
The purpose of this study is to characterize the safety and tolerability of ALTA2618 in adults with AKT1 E17K-mutant advanced solid tumors.
Detailed Description
This is an open-label, multicenter, Phase 1/1b study of ALTA2618, a mutant-selective and orally bioavailable AKT1 E17K inhibitor, in adults with AKT1 E17K-mutant solid tumors. This study will evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary clinical activity of ALTA2618, and aims to find the best dose. The study consists of two parts: Part 1 – Dose Escalation and Part 1b – Dose Expansion.
Locations
8 locations Found with status Recruiting
Status
- RECRUITING
Central Contacts
- Alterome Clinical Trial Contact Center
- 619-768-8189
- [email protected]
Study Director
- Study Medical Director
Status
- RECRUITING
Central Contacts
- Alterome Clinical Trial Contact Center
- 619-768-8189
- [email protected]
Study Director
- Study Medical Director
Status
- RECRUITING
Central Contacts
- Alterome Clinical Trial Contact Center
- 619-768-8189
- [email protected]
Study Director
- Study Medical Director
Status
- RECRUITING
Central Contacts
- Alterome Clinical Trial Contact Center
- 619-768-8189
- [email protected]
Study Director
- Study Medical Director
Status
- RECRUITING
Central Contacts
- Alterome Clinical Trial Contact Center
- 619-768-8189
- [email protected]
Study Director
- Study Medical Director
Status
- RECRUITING
Central Contacts
- Alterome Clinical Trial Contact Center
- 619-768-8189
- [email protected]
Study Director
- Study Medical Director
Status
- RECRUITING
Central Contacts
- Alterome Clinical Trial Contact Center
- 619-768-8189
- [email protected]
Study Director
- Study Medical Director
Status
- RECRUITING
Central Contacts
- Alterome Clinical Trial Contact Center
- 619-768-8189
- [email protected]
Study Director
- Study Medical Director
Eligibility 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.
Study Plan
ALTA2618
EXPERIMENTAL
ALTA2618 will be administered continuously at a protocol-defined dose based on cohort assignment
DRUG:
ALTA2618Description:
Oral ALTA2618 tablets will be administered at protocol-defined dose
Outcome Measures
Primary Outcome Measures
Adverse Events
Dose Limiting Toxicities
Secondary Outcome Measures
Maximum Observed Plasma Concentration (Cmax)
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Area Under Plasma Concentration Time Curve During the Dosing Interval (AUCt)
Terminal Half-Life (t1/2)
Overall Response Rate (ORR)
Duration of Response (DOR)
Progression-Free Survival (PFS)
Overall Survival (OS)
Timeline
Last Updated
October 15, 2024Start Date
August 1, 2024Today
February 5, 2025Completion Date ( Estimated )
December 29, 2027
Sponsors of this trial
Lead Sponsor
Alterome Therapeutics, Inc.