Trials / Completed
CompletedNCT03452150
D-0316 First Time in Patients Ascending Dose Study
A Phase I Study of D-0316 in Patients With Advanced Non Small Cell Lung Cancer With Mutation of Epidermal Growth Factor Receptor Tyrosine Kinase
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 84 (actual)
- Sponsor
- InventisBio Co., Ltd · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This is a phase 1 open label multicentre study of D-0316 administered orally in patients with advanced NSCLC who have progressed following prior therapy with an EGFR-TKI (Epidermal Growth Factor Receptor tyrosine kinase inhibitor agent). This is the first time this drug has ever been tested in patients, and so it will help to understand safety, tolerability, pharmacokinetics and preliminary anti-tumour activity of ascending doses of D-0316.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | D-0316 | If initial dosing of D-0316 is tolerated then subsequent cohorts will test increasing doses until a maximum tolerated dose or maximum feasible dose is defined |
Timeline
- Start date
- 2018-01-03
- Primary completion
- 2020-08-28
- Completion
- 2020-12-31
- First posted
- 2018-03-02
- Last updated
- 2023-04-25
Locations
3 sites across 1 country: China
Source: ClinicalTrials.gov record NCT03452150. Inclusion in this directory is not an endorsement.