Clinical trial · Interventional
Testing Ipatasertib as Potentially Targeted Treatment in Cancers With AKT Genetic Changes (MATCH - Subprotocol Z1K)
MATCH Treatment Subprotocol Z1K: Ipatasertib in Patients With Tumors With AKT Mutations
NCT06400251CI-TRIAL-00113206active not recruitingPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This phase II MATCH treatment trial tests how well ipatasertib works in treating patients with cancer that has certain genetic changes called AKT mutations. Ipatasertib is in a class of medications called protein kinase B (AKT) inhibitors. It may stop the growth of cancer cells and may kill them.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Lymphoma | Lymphoma | CURATED_BROADER | 0.78 |
| Advanced Malignant Solid Neoplasm | Malignant Solid Neoplasm | CURATED_BROADER | 0.78 |
| Refractory Lymphoma | Lymphoma | CURATED_BROADER | 0.78 |
| Refractory Malignant Solid Neoplasm | Malignant Solid Neoplasm | CURATED_BROADER | 0.78 |
| Refractory Multiple Myeloma | Multiple Myeloma | CURATED_BROADER | 0.78 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biopsy Procedure | Procedure | — | UNRESOLVED |
| Biospecimen Collection | Procedure | — | UNRESOLVED |
| Computed Tomography | Procedure | — | UNRESOLVED |
| Ipatasertib | Drug | Ipatasertib | ALIAS |
| Magnetic Resonance Imaging | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (ipatasertib)
- description
- Patients receive ipatasertib 400 mg PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo CT or MRI during screening and on study, as well as during follow-up as clinically necessary. Patients undergo biopsies and blood sample collection on study.
- interventionNames
- Procedure: Biopsy Procedure
- Procedure: Biospecimen Collection
- Procedure: Computed Tomography
- Drug: Ipatasertib
- Procedure: Magnetic Resonance Imaging
Primary outcomes (1)
- measure
- Objective Response Rate (ORR)
- timeFrame
- Tumor assessments occurred at baseline, then every 2 cycles for the first 26 cycles and every 3 cycles thereafter until disease progression, up to 3 years post registration
- description
- ORR is defined as the percentage of patients whose tumors have a complete or partial response to treatment among analyzable patients. Objective response is defined consistent with Response Evaluation Criteria in Solid Tumors version 1.1, the Cheson (2014) criteria for lymphoma patients, and the Response Assessment in Neuro-Oncology criteria for glioblastoma patients. Details about how to define complete response and partial response can be found in the master protocol. 90% two-sided binomial exact confidence interval is calculated for ORR.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.