Trial purpose
Cancer treatment
Tumor type
Multi-Cancer
Age
18+
Clinical summary
Summary
The purpose of this study is to understand how safe and tolerable a drug called ALTA2618 is in adults with AKT1 E17K mutation advanced solid cancers.
To be eligible, participants should have progressed on, been intolerant to, or declined prior standard of care treatment.
The study consists of two parts: Part 1- Dose Escalation, and Part 1b - Dose Expansion.
ALTA2618 is a targeted drug that will be administered continuously at a protocol-defined dose based on cohort assignment.
Conditions
This trial is treating people with solid cancers with an identified AKT1 E17K mutation that is metastatic or unable to be removed through surgery (unresectable)
Eligibility
Inclusion
- 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
- 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.
Inclusion
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
- Your cancer has not spread to other parts of the body, but it is not possible to perform surgery to remove it (unresectable).
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
- You are able to swallow medication by mouth.
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Alterome Therapeutics, Inc.
Scientific Title
A Phase 1/1b Multiple Cohort Trial of ALTA2618 in Patients with Advanced Solid Tumors with AKT1 E17K Mutation
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