Trials / Terminated
TerminatedNCT04518137
A Study of Evaluating the Safety and Efficacy of ATG-008 for Advanced Solid Tumors (BUNCH)
An Open-Label, Single-Arm Basket Study of ATG-008 for the Treatment of Patients With Advanced Solid Tumors Harboring NFE2L2, STK11, RICTOR or Other Specific Genetic Alterations
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 5 (actual)
- Sponsor
- Shanghai Antengene Corporation Limited · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a single-arm and open-label study of ATG-008 for the Treatment of Patients With advanced Solid Tumors harboring NFE 2L2, STK11, RICTOR or other specific genetic alterationts
Detailed description
This is a single-arm and open-label study. Approximately 10-12 patients will be enrolled per each genetic alterration group in the study. ATG-008 is the monotherapy for advanced solid tumors with 30mg QD. The clinical efficacy, safety and tolerability of ATG-008 will be evaluated. Addtionalal dose levels may apply after the efficacy/safety and tolerabitly of 30mg QD has been accessed by Sponosor and study steering committee.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ATG-008 30 mg, orally, QD, each 4 week (28-day) a cycle | 48 patients enrolled will be treated with 30mg QD of ATG-008, orally, each 4 week (28-day) a cycle |
Timeline
- Start date
- 2021-04-09
- Primary completion
- 2022-05-30
- Completion
- 2022-05-30
- First posted
- 2020-08-19
- Last updated
- 2023-01-31
Locations
4 sites across 1 country: China
Source: ClinicalTrials.gov record NCT04518137. Inclusion in this directory is not an endorsement.