ALTA2618 for Cancer

Recruiting at 31 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

Trial Summary

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.

What is the purpose of this trial?

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

Research Team

Study Medical Director

Principal Investigator

Alterome Therapeutics

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+