Advanced Solid Tumor, Breast Cancer, Cancer, Endometrial Cancer, Metastatic Cancer
Conditions
Keywords
AKT1 E17K, Breast cancer, Breast carcinoma, Breast neoplasm, ER positive breast, HR positive breast, Triple negative breast cancer, Gynecologic cancer, Gynecologic neoplasm, Gynecologic carcinoma, Endometrial cancer, Endometrial neoplasm, Endometrial carcinoma, Cervical cancer, Cervical neoplasm, Cervical carcinoma, Ovarian cancer, Ovarian carcinoma, Ovarian neoplasm, Fallopian cancer, Fallopian carcinoma, Fallopian neoplasm, Prostate cancer, Prostate carcinoma, Prostate neoplasm, Solid tumors, AKT mutation, Mutant AKT, AKT1 mutation, AKT mutant, AKT1E17K
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.
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.
Interventions
DRUGALTA2618
Oral ALTA2618 tablets will be administered at protocol-defined dose
Sponsors
Alterome Therapeutics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | Up to 39 months | Number of participants that experience treatment-emergent adverse events (TEAEs). |
| Dose Limiting Toxicities | 21 days | Number of participants with Dose Limiting Toxicities (DLTs). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) | Cycle 1 (each cycle is 21 days) Day 1 (or Lead-in) and Day 8: Predose and up to 24 hours postdose | Cmax |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) | Cycle 1 (each cycle is 21 days) Day 1 (or Lead-in) and Day 8: Predose and up to 24 hours postdose | Tmax |
| Area Under Plasma Concentration Time Curve During the Dosing Interval (AUCt) | Cycle 1 (each cycle is 21 days) Day 1 (or Lead-in) and Day 8: Predose and up to 24 hours postdose | AUCt |
| Terminal Half-Life (t1/2) | Cycle 1 (each cycle is 21 days) Lead-in phase: Predose and up to 72 hours postdose | t1/2 |
| Overall Response Rate (ORR) | Up to 39 months | Assess per RECIST 1.1 |
| Duration of Response (DOR) | Up to 39 months | Assess per RECIST 1.1 |
| Progression-Free Survival (PFS) | Up to 39 months | Assess per RECIST 1.1 |
| Overall Survival (OS) | Up to 39 months | Assess per RECIST 1.1 |
Countries
Australia, France, Japan, South Korea, Spain, Taiwan, United Kingdom, United States
Contacts
STUDY_DIRECTORStudy Medical Director
Alterome Therapeutics
Outcome results
None listed