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

NCT06533059 | Recruiting Phase 1 FDA Drug

• 1 other identifier: 2618-001
• Study Type: interventional
• Target: 110
• Locations: 8 countries
• Sites: 51

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.

Conditions

Cancer; Breast Cancer; Endometrial Cancer; Metastatic Cancer; Advanced Solid Tumor

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

Outcome Measures

Primary Outcomes (2)

• Adverse Events

  Number of participants that experience treatment-emergent adverse events (TEAEs).

  Up to 39 months

• Dose Limiting Toxicities

  Number of participants with Dose Limiting Toxicities (DLTs).

  21 days

Secondary Outcomes (8)

• 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

• 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

• 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

• Terminal Half-Life (t1/2)

  Cycle 1 (each cycle is 21 days) Lead-in phase: Predose and up to 72 hours postdose

• Overall Response Rate (ORR)

  Up to 39 months

Study Arms (1)

ALTA2618

EXPERIMENTAL

ALTA2618 will be administered continuously at a protocol-defined dose based on cohort assignment

Drug: ALTA2618

Interventions

ALTA2618 DRUG

Oral ALTA2618 tablets will be administered at protocol-defined dose

ALTA2618

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify 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

Sponsors & Collaborators

• Alterome Therapeutics, Inc.: lead

Study Sites (51)

Research Site

La Jolla, California, 92093, United States

RECRUITING

Research Site

Los Angeles, California, 90095, United States

RECRUITING

Research Site

Denver, Colorado, 80218, United States

RECRUITING

Research Site

Sarasota, Florida, 34232, United States

RECRUITING

Research Site

Atlanta, Georgia, 30322, United States

RECRUITING

Research Site

Boston, Massachusetts, 02114, United States

RECRUITING

Research Site

Boston, Massachusetts, 02215, United States

RECRUITING

Research Site

St Louis, Missouri, 63110, United States

RECRUITING

Research Site

Mineola, New York, 11501, United States

RECRUITING

Research Site

New York, New York, 10016, United States

RECRUITING

Research Site

Maumee, Ohio, 43637, United States

RECRUITING

Research Site

Nashville, Tennessee, 37203, United States

RECRUITING

Research Site

Dallas, Texas, 75230, United States

WITHDRAWN

Research Site

Houston, Texas, 77030, United States

RECRUITING

Research Site #2

San Antonio, Texas, 78229, United States

RECRUITING

Research Site

San Antonio, Texas, 78229, United States

RECRUITING

Research Site

Fairfax, Virginia, 22031, United States

RECRUITING

Research Site

Madison, Wisconsin, 53792, United States

RECRUITING

Research Site

Blacktown, New South Wales, 2148, Australia

RECRUITING

Research Site

Randwick, New South Wales, 2031, Australia

RECRUITING

Research Site

South Brisbane, Queensland, 4101, Australia

RECRUITING

Research Site

Malvern, Victoria, 3144, Australia

RECRUITING

Research Site

Nedlands, Western Australia, 6009, Australia

RECRUITING

Research Site

Caen, 14000, France

RECRUITING

Research Site

Dijon, 21000, France

RECRUITING

Research Site

Saint-Herblain, 44805, France

RECRUITING

Research Site

Villejuif, 94800, France

RECRUITING

Research Site

Kyoto, 606-8507, Japan

RECRUITING

Research Site

Matsuyama, 791-0280, Japan

RECRUITING

Research Site

Shizuoka, 411-8777, Japan

RECRUITING

Research Site

Tokyo, 135-8550, Japan

RECRUITING

Research Site

Seoul, 03722, South Korea

RECRUITING

Research Site

Seoul, 05505, South Korea

RECRUITING

Research Site

Seoul, 06351, South Korea

RECRUITING

Research Site

Seoul, 06591, South Korea

RECRUITING

Research Site

Seoul, 13620, South Korea

RECRUITING

Research Site

Barcelona, 08023, Spain

RECRUITING

Research Site

Barcelona, 08035, Spain

RECRUITING

Research Site

Barcelona, 08908, Spain

RECRUITING

Research Site

Madrid, 28023, Spain

RECRUITING

Research Site

Madrid, 28040, Spain

RECRUITING

Research Site

Valencia, 46010, Spain

RECRUITING

Research Site

Changhua, 500, Taiwan

RECRUITING

Research Site

Taipei, 100, Taiwan

RECRUITING

Research Site

Taipei, 10449, Taiwan

RECRUITING

Research Site

London, SW3 6JJ, United Kingdom

RECRUITING

Research Site

London, W1G 6AD, United Kingdom

RECRUITING

Research Site

London, W1T 7HA, United Kingdom

RECRUITING

Research Site

Manchester, M10 4BX, United Kingdom

RECRUITING

Research Site

Newcastle upon Tyne, NE7 7DN, United Kingdom

RECRUITING

Research Site

Sutton, SM2 5PT, United Kingdom

RECRUITING

MeSH Terms

Conditions

Neoplasms; Breast Neoplasms; Endometrial Neoplasms; Neoplasm Metastasis; Triple Negative Breast Neoplasms; Genital Neoplasms, Female; Uterine Cervical Neoplasms; Ovarian Neoplasms; Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Uterine Neoplasms; Urogenital Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Uterine Cervical Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Endocrine System Diseases; Gonadal Disorders; Genital Neoplasms, Male; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Study Medical Director

  Alterome Therapeutics

  STUDY DIRECTOR

Central Study Contacts

Alterome Clinical Trial Contact Center

CONTACT

619-768-8189; clinical.trials@alterome.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2024
• First Posted: August 1, 2024
• Study Start: August 22, 2024
• Primary Completion (Estimated): December 29, 2026
• Study Completion (Estimated): December 29, 2027
• Last Updated: March 9, 2026

Record last verified: 2026-03

Locations

ES (6); KR (5); US (18); FR (4); GB (6); TW (3); AU (5); JP (4)