Clinical Trials in Spain / NCT06533059
Active, not recruiting
Phase 1
A Study to Learn About Study Medicine ALTA2618 in Adults With AKT1 E17K-Mutant Solid Tumors
NCT06533059 · tracked via the Priya Life Science Spain tracker
Condition(s) studied
CancerBreast CancerEndometrial CancerMetastatic CancerAdvanced Solid Tumor
Investigational drug(s) / intervention(s)
ALTA2618
ALTA2618: Oral ALTA2618 tablets will be administered at protocol-defined dose
Study summary
The purpose of this study is to characterize the safety and tolerability of ALTA2618 in adults with AKT1 E17K-mutant advanced solid tumors.
Eligibility
Inclusion Criteria:
* 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 Criteria:
* 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.
Primary outcome measure(s)
- Adverse Events — Up to 39 months
Number of participants that experience treatment-emergent adverse events (TEAEs). - Dose Limiting Toxicities — 21 days
Number of participants with Dose Limiting Toxicities (DLTs).
Trial sites (31)
| Facility | City | Region | Status |
|---|---|---|---|
| Research Site | La Jolla | California | |
| Research Site | Denver | Colorado | |
| Research Site | Sarasota | Florida | |
| Research Site | Boston | Massachusetts | |
| Research Site | Boston | Massachusetts | |
| Research Site | St Louis | Missouri | |
| Research Site | Nashville | Tennessee | |
| Research Site | Houston | Texas | |
| Research Site #2 | San Antonio | Texas | |
| Research Site | San Antonio | Texas | |
| Research Site | Fairfax | Virginia | |
| Research Site | Madison | Wisconsin | |
| Research Site | Randwick | New South Wales | |
| Research Site | Malvern | Victoria | |
| Research Site | Nedlands | Western Australia | |
| Research Site | Caen | France | |
| Research Site | Villejuif | France | |
| Research Site | Kyoto | Japan | |
| Research Site | Tokyo | Japan | |
| Research Site | Seoul | South Korea | |
| Research Site | Seoul | South Korea | |
| Research Site | Barcelona | Spain | |
| Research Site | Barcelona | Spain | |
| Research Site | Madrid | Spain | |
| Research Site | Madrid | Spain | |
| Research Site | Taipei | Taiwan | |
| Research Site | London | United Kingdom | |
| Research Site | London | United Kingdom | |
| Research Site | Manchester | United Kingdom | |
| Research Site | Newcastle upon Tyne | United Kingdom | |
| Research Site | Sutton | United Kingdom |
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06533059 on ClinicalTrials.gov ↗ ← All trials in Spain