ALTA2618 for Cancer

Recruiting at 40 trial locations

Overseen By Alterome Clinical Trial Contact Center

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Alterome Therapeutics, Inc.

Must not be taking: PI3K inhibitors, mTOR inhibitors

Disqualifiers: KRAS, NRAS, HRAS, BRAF, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

110 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, ALTA2618, for individuals with advanced solid tumors that have a specific genetic change called the AKT1 E17K mutation. The main goal is to determine if the treatment is safe and well-tolerated. It targets those with tumors that cannot be surgically removed or have spread, and who have not responded to other treatments. Participants must be able to take oral medications and should not have certain other genetic changes. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that ALTA2618 is likely to be safe for humans?

Research has shown that ALTA2618 could be a promising treatment for some advanced cancers. It targets a specific change in cancer cells called the AKT1 E17K mutation, present in some tumors. Early results suggest that ALTA2618 is generally safe as a once-daily pill, with most people not experiencing serious side effects.

Studies have demonstrated positive results in how the body absorbs and uses ALTA2618, which is crucial for effectively reaching and impacting cancer cells. Although these findings are promising, ALTA2618 remains in the early stages of human testing. Researchers are currently focusing on its safety and are closely monitoring for any side effects. While there is some uncertainty with any new treatment, the safety of ALTA2618 appears promising so far. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

ALTA2618 is unique because it targets cancer cells with a novel mechanism of action that is different from traditional chemotherapy and radiation treatments. Unlike standard treatments that often affect both healthy and cancerous cells, ALTA2618 is designed to specifically disrupt cancer cell growth, potentially offering a more precise and less toxic option. Researchers are excited about ALTA2618 because it represents a new class of targeted therapy, which could lead to improved outcomes and fewer side effects for patients battling cancer.

What evidence suggests that ALTA2618 might be an effective treatment for advanced solid tumors?

Studies have shown that ALTA2618 effectively blocks a specific change in cancer cells called AKT1 E17K. This means it targets and stops this altered protein, which often promotes the growth of certain advanced solid tumors. ALTA2618, the investigational treatment in this trial, demonstrated promising results in early tests, with good drug levels in the body and good tolerance when taken once daily by mouth. These early findings suggest that ALTA2618 could be effective for patients with cancers driven by the AKT1 E17K mutation. ^{2 3 4 5 6}

Who Is on the Research Team?

Study Medical Director

Principal Investigator

Alterome Therapeutics

Are You a Good Fit for This Trial?

This trial is for adults with advanced solid tumors that have a specific mutation called AKT1 E17K. It's open to those who haven't had success with previous treatments or for whom no suitable alternatives exist.

Inclusion Criteria

My cancer cannot be removed by surgery or has spread.

My cancer has worsened or I can't tolerate/declined standard treatments.

Evaluable or measurable disease per RECIST v1.1

Exclusion Criteria

I have been treated with PI3K or mTOR inhibitors before.

My tumor has a KRAS, NRAS, HRAS, or BRAF mutation.

I cannot swallow or absorb pills due to a medical condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive ALTA2618 at increasing doses to determine the maximum tolerated dose

21 days per cycle

Multiple visits per cycle for dose adjustments and monitoring

Dose Expansion

Participants receive ALTA2618 at the determined dose to further evaluate safety and efficacy

21 days per cycle

Regular visits for treatment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 39 months

What Are the Treatments Tested in This Trial?

Interventions

• ALTA2618

Trial Overview

The study is testing the safety and how well people can tolerate ALTA2618, which is a new medication aimed at targeting certain mutations in tumor cells.

How Is the Trial Designed?

Group I: ALTA2618 Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Alterome Therapeutics, Inc.

Lead Sponsor

Trials

2

Recruited

240+

Citations

1.

aacrjournals.org

aacrjournals.org/cancerres/article/84/7_Supplement/LB173/742257/Abstract-LB173-Discovery-of-ALTA-2618-the-first

Abstract LB173: Discovery of ALTA-2618, the first allosteric ...

ALTA-2618 is a potent, highly mutant-selective AKT1 E17K inhibitor that demonstrates favorable PK and tolerability with oral once-daily dosing.

2.

clinicaltrials.med.nyu.edu

clinicaltrials.med.nyu.edu/cancer/clinicaltrial/2770/aktive-001-phase-11b-multiple/

AKTive-001: A Phase 1/1b Multiple Cohort Trial of ALTA2618 ...

This trial is designed to test the effectiveness of ALTA2618 in patients with advanced solid tumors that have a specific genetic mutation (AKT1 E17K).

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06533059

NCT06533059 | A Study to Learn About ...

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.

4.

synapse.patsnap.com

synapse.patsnap.com/blog/first-patient-dosed-in-alteromes-phase-1-trial-of-alta2618-for-akt1-e17k-mutant-solid-tumors

First Patient Dosed in Alterome's Phase 1 Trial of ...

This Phase 1/1b study is investigating ALTA2618 in adult patients with advanced solid tumors harboring the AKT1 E17K mutation.

5.

clinicaltrialvanguard.com

clinicaltrialvanguard.com/news/alterome-uncovers-pre-clinical-data-for-lead-akt1-e17k-inhibitor-program-development/

Alterome Uncovers Pre-Clinical Data for Lead AKT1 E17K ...

This study will evaluate the safety, tolerability, and efficacy of ALTA-2618 in patients with AKT1 E17K-driven cancers who have exhausted ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06533059

NCT06533059 | A Study to Learn About ...

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.