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NCT05103358 · ClinicalTrials.gov registry record · Phase 2
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 study of Cancer and Solid Tumor, sponsored by Aadi Bioscience.
- Active
- Registry status
- Phase 2
- Development phase
- 120
- Enrollment target
- 20
- Study locations
NCT05103358: Active Phase 2 study of Cancer and Solid Tumor, sponsored by Aadi Bioscience.
NCT05103358 is a Phase 2 study of Cancer and Solid Tumor that is active but no longer recruiting, run by Aadi Bioscience. The registered enrollment target is 120 participants, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (97% lower). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05103358, a Phase 2 study of Cancer and Solid Tumor, is active but no longer recruiting, sponsored by Aadi Bioscience.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 120 participants
- Enrollment target
- 20
- Study locations
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
Primary Outcome
ORR based on the proportion of patients with best overall response (BOR) of confirmed partial response (PR) or complete response (CR) from the time of study treatment initiation until disease progression as determined by IRR using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
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 |
What the registry record for NCT05103358 still lists
NCT05103358 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (97% lower).
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.
NCT05103358 names 20 study sites across 3 states, led by California, Arizona, Alabama.
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.
What interventions are being tested in trial NCT05103358?
The interventions under investigation include: nab-sirolimus (DRUG).
Who is sponsoring clinical trial NCT05103358?
This trial is sponsored by Aadi Bioscience, which has 9 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT05103358's enrollment target sits among peer trials
120 288th of 615 higher than 321 of 615 other Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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