Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Los Angeles, California and other locations
Dates
study started
completion around
Principal Investigator
by Marla D. Lipsyc-Sharf, MD
Headshot of Marla D. Lipsyc-Sharf
Marla D. Lipsyc-Sharf

Description

Summary

The purpose of this study is to characterize the safety and tolerability of ALTA2618 in adults with AKT1 E17K-mutant advanced solid tumors.

Official Title

AKTive-001: A Phase 1/1b Multiple Cohort Trial of ALTA2618 in Patients With Advanced Solid Tumors With AKT1 E17K Mutation

Details

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.

Keywords

Cancer, Breast Cancer, Endometrial Cancer, Metastatic Cancer, Advanced Solid Tumor, AKT1 E17K, Breast carcinoma, Breast neoplasm, ER positive breast, HR positive breast, Triple negative breast cancer, Gynecologic cancer, Gynecologic neoplasm, Gynecologic carcinoma, 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, Breast Neoplasms, Endometrial Neoplasms, ALTA2618

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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.

Locations

  • Research Site accepting new patients
    Los Angeles California 90095 United States
  • Research Site accepting new patients
    Denver Colorado 80218 United States

Lead Scientist at UCLA

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Alterome Therapeutics, Inc.
Links
Sign up for this study
ID
NCT06533059
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 110 study participants
Last Updated