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

Clinicaltrials.gov ID: NCT06533059
db-list-check Status RECRUITING
b-loader Phase PHASE1
b-people Age ≥ 18 Years
b-bullseye-arrow Enrollments 110

Conditions

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

Drugs

ALTA2618

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.

Locations

8 locations Found with status Recruiting

Status

  • RECRUITING

Central Contacts

Study Director

  • Study Medical Director

Status

  • RECRUITING

Central Contacts

Study Director

  • Study Medical Director

Status

  • RECRUITING

Central Contacts

Study Director

  • Study Medical Director

Status

  • RECRUITING

Central Contacts

Study Director

  • Study Medical Director

Status

  • RECRUITING

Central Contacts

Study Director

  • Study Medical Director

Status

  • RECRUITING

Central Contacts

Study Director

  • Study Medical Director

Status

  • RECRUITING

Central Contacts

Study Director

  • Study Medical Director

Status

  • RECRUITING

Central Contacts

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:

    ALTA2618

    Description:

    Oral ALTA2618 tablets will be administered at protocol-defined dose

Outcome Measures

Primary Outcome Measures

Adverse Events

Time Frame: Up to 39 months

Dose Limiting Toxicities

Time Frame: 21 days

Secondary Outcome Measures

Maximum Observed Plasma Concentration (Cmax)

Time Frame: 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)

Time Frame: 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)

Time Frame: 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)

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

Overall Response Rate (ORR)

Time Frame: Up to 39 months

Duration of Response (DOR)

Time Frame: Up to 39 months

Progression-Free Survival (PFS)

Time Frame: Up to 39 months

Overall Survival (OS)

Time Frame: Up to 39 months

Timeline

  • Last Updated
    October 15, 2024
  • Start Date
    August 1, 2024
  • Today
    February 5, 2025
  • Completion Date ( Estimated )
    December 29, 2027

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