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Phase 2 Basket Trial of Nab-sirolimus in Patients With Malignant Solid Tumors With Pathogenic Alterations in TSC1/TSC2 Genes (PRECISION 1)
NCT05103358 · View on ClinicalTrials.gov ↗
Study Summary
A Phase 2 multi-center open-label basket trial of nab-sirolimus for adult and adolescent patients with malignant solid tumors harboring pathogenic inactivating alterations in TSC1 or TSC2 genes
Conditions Studied
Interventions
- DRUG nab-sirolimus
Study Locations (20)
California
- PCR Oncology — Arroyo Grande
- Nextgen Oncology — Beverly Hills
- City of Hope — Duarte
- Providence Medical Foundation (Fullerton) — Fullerton
- MemorialCare — Long Beach
- USC Norris Comprehensive Cancer Center — Los Angeles
- UCLA - Jonsson Comprehensive Cancer Center — Los Angeles
- Providence Medical Foundation (Napa) — Napa
- Hoag Memorial Hospital Presbyterian — Newport Beach
- Sharp HealthCare — San Diego
- UCSF Helen Diller Family Comprehensive Cancer Center — San Francisco
- Ridley-Tree Cancer Center — Santa Barbara
- Sarcoma Oncology Research Center — Santa Monica
- Providence Medical Foundation — Santa Rosa
Arizona
- Arizona Oncology Associates — Goodyear
- Honor Health — Phoenix
- Arizona Oncology Associates — Prescott Valley
- Yuma Regional Medical Center — Yuma
Alabama
- Alabama Oncology — Birmingham
- Southern Cancer Center — Mobile
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2022-02-15 |
| Est. Completion | 2025-12-31 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05103358
The ClinicalTrials.gov registry entry for NCT05103358 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Aadi Bioscience, which has 5 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 10 conditions, with Cancer appearing as the primary indexed condition, and to 1 intervention — of which nab-sirolimus is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05103358 reports 20 study locations spanning 3 distinct geographic areas — top geographies include California, Arizona, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05103358 about?
NCT05103358 is a clinical study titled "Phase 2 Basket Trial of Nab-sirolimus in Patients With Malignant Solid Tumors With Pathogenic Alterations in TSC1/TSC2 Genes (PRECISION 1)". A Phase 2 multi-center open-label basket trial of nab-sirolimus for adult and adolescent patients with malignant solid tumors harboring pathogenic inactivating alterations in TSC1 or TSC2 genes
What is the current status of trial NCT05103358?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 2022-02-15. Estimated completion is 2025-12-31.
What conditions does trial NCT05103358 study?
This clinical trial studies the following conditions: Cancer, Solid Tumor, Neoplasms, Metastatic Cancer, Neoplasm Metastasis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05103358?
The interventions under investigation include: nab-sirolimus (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05103358?
This trial is sponsored by Aadi Bioscience, which has 5 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05103358 being conducted?
This trial has 20 study locations across Alabama, Arizona, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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