Trials / Completed
CompletedNCT04204473
A Study of TY-9591 in Advanced Non-small Cell Lung Cancer(NSCLC) Patients With EGFR Positive Mutation
Phase I, Open-label, Single-arm Study to Evaluate the Safety, Tolerance, Pharmacokinetics and Preliminary Efficacy of TY-9591 Tablets in Advanced NSCLC Patients With Epidermal Growth Factor Receptor( EGFR) Positive Mutation
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 105 (actual)
- Sponsor
- TYK Medicines, Inc · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this study is to evaluate the safety and tolerability of TY-9591, with dose-escalation stage and dose-expansion stage.
Detailed description
* To define the maximum tolerated dose(MTD) and the recommended phase 2 dose (RP2D) * To investigate the pharmacokinetic profile of TY-9591 and its metabolites after single then multiple doses of TY-9591 administered orally once daily * To evaluate the anti-cancer activity of TY-9591 in NSCLC patients with EGFR mutation(ORR、PFS、DoR、DCR、and CBR)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TY-9591(10mg,40mg) qd. po | Increased dose cohorts from low dose to MTD(20mg Cohort1, 40mg Cohort2, 80mg Cohort3,120mg Cohort4, 160mg Cohort5, 200mg Cohort6) |
Timeline
- Start date
- 2020-05-07
- Primary completion
- 2023-03-03
- Completion
- 2023-05-18
- First posted
- 2019-12-19
- Last updated
- 2023-11-18
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04204473. Inclusion in this directory is not an endorsement.