ALTA2618 for Cancer

Recruiting in Palo Alto (17 mi)

+15 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Alterome Therapeutics, Inc.

Must not be taking: PI3K inhibitors, mTOR inhibitors

Disqualifiers: KRAS, NRAS, HRAS, BRAF, others

No Placebo Group

Trial Summary

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.

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.

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

See 3 more

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.

Trial 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 (AKT Inhibitor)

Trial OverviewThe 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

1Treatment groups

Experimental Treatment

Group I: ALTA2618Experimental Treatment1 Intervention

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