New drug targets AKT mutations in Hard-to-Treat cancers
NCT ID NCT06400251
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial tests the drug ipatasertib in 35 adults with advanced cancers (solid tumors, lymphoma, or multiple myeloma) that have a specific AKT gene mutation. Ipatasertib is an AKT inhibitor designed to block cancer growth signals. The main goal is to see if the drug can shrink tumors or stop them from growing. Participants will take the drug and undergo biopsies, blood draws, and CT scans to monitor response.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Ipatasertib (an AKT inhibitor drug)
- What this could lead to
- If it works, this could point toward a targeted treatment option for patients with AKT-mutated cancers that are hard to treat.
- What could go wrong
- This is a small, early-phase trial (35 patients) with no control group. The drug may not shrink tumors or improve survival, and side effects are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
35 people
The number who actually took part.
- Started
-
Aug 2019
- Expected to finish
-
Jan 2027
An estimate. End dates often move.
- Lead sponsor
-
A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients must have met applicable eligibility criteria in the Master MATCH Protocol EAY131/ NCI-2015-00054 prior to registration to treatment subprotocol * Patients must have an AKT mutation as determined via the MATCH Master Protocol * Patients with breast cancer are excluded * Patients with castration-resistant prostate cancer should maintain castrate levels of testosterone (i.e., with gonadotropin-releasing hormone (GnRH) agonists or through surgical castration). Patients are allowed to continue abiraterone acetate/prednisone with Ipatasertib if the patient just progressed on abiraterone acetate/prednisone * Patients must not have known hypersensitivity to Ipatasertib or compounds of similar chemical or biologic composition * Patients with known KRAS, NRAS, HRAS, or BRAF mutations are not eligible for this protocol, as these mutations may lead to limited response due to resistance * Patients with diabetes or risk for hyperglycemia are eligible. Patients with diabetes mellitus should be on a stable dose of oral hypoglycemic agents for \>= 4 weeks and appropriate diet. Patients with diabetes mellitus may enter the study unless any of the following exclusion criteria are fulfilled: * Baseline fasting glucose value of \> 8.9 mmol/L or 160 mg/dL (fasting is defined as no calorific intake for at least 8 hours) * Patients not on a stable dose of oral hypoglycemic medication for \>= 4 weeks and appropriate diet * Insulin required for routine diabetic management and control * More than two oral hypoglycemic medications required for routine diabetic management and control * Glycosylated hemoglobin (hemoglobin A1C) \>= 7.5% * Prior PI3K and mTOR inhibitors are allowed, including in the metastatic setting. Prior AKT inhibitors are excluded * Patients with a history of inflammatory bowel diseases (Crohn's disease and ulcerative colitis) or active diverticulitis are not eligible * Patients may not have received strong inhibitors or potent inducers or substrates of CYP3A4/5 within 2 weeks before the first dose of study treatment (3 weeks for St John's wort) * In addition to the patient contraception requirements outlined in EAY131 MATCH Master Protocol, male patients must also refrain from donating sperm for the duration of study participation, and for 4 months after completion of study
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
ECOG-ACRIN Cancer Research Group
Philadelphia, Pennsylvania, 19103, United States
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