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A Study to Learn About Study Medicine ALTA2618 in Adults With AKT1 E17K-Mutant Solid Tumors
A Study to Learn About Study Medicine ALTA2618 in Adults With AKT1 E17K-Mutant Solid Tumors

NCT06533059

Active Not RecruitingPhase 1

Sponsor: Alterome Therapeutics, Inc.

Conditions: Cancer, Breast Cancer, Endometrial Cancer, Metastatic Cancer, Advanced Solid Tumor

Interventions: ALTA2618

Countries: United States, Australia, France, Japan, South Korea, Spain, Taiwan, United Kingdom

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

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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.
Locations (31)
  • La Jolla, California, United States
  • Denver, Colorado, United States
  • Sarasota, Florida, United States
  • Boston, Massachusetts, United States
  • Boston, Massachusetts, United States
  • St Louis, Missouri, United States
  • Nashville, Tennessee, United States
  • Houston, Texas, United States
  • San Antonio, Texas, United States
  • San Antonio, Texas, United States
  • Fairfax, Virginia, United States
  • Madison, Wisconsin, United States
  • Randwick, New South Wales, Australia
  • Malvern, Victoria, Australia
  • Nedlands, Western Australia, Australia
  • Caen, France
  • Villejuif, France
  • Kyoto, Japan
  • Tokyo, Japan
  • Seoul, South Korea
  • Seoul, South Korea
  • Barcelona, Spain
  • Barcelona, Spain
  • Madrid, Spain
  • Madrid, Spain
  • Taipei, Taiwan
  • London, United Kingdom
  • London, United Kingdom
  • Manchester, United Kingdom
  • Newcastle upon Tyne, United Kingdom
  • + 1 more on CT.gov