Trials / Unknown
UnknownNCT04993391
AP-L1898 Capsule in Patients With Non-small Cell Lung Cancer
A Dose-escalation, Dose-extension and Efficacy-extension, Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile and Preliminary Efficacy of AP-L1898 Capsule for the Treatment of the Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer
- Status
- Unknown
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 156 (estimated)
- Sponsor
- Suzhou Junjing BioSciences Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a phase I/II, open-label, first-in-human clinical study designed to evaluate the safety, tolerability, PK profile and efficacy of JS111 for patients with Non-small cell lung cance. This study is divided into 3 periods: dose escalation stage, dose extension stage, and efficacy extension stage.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | JS111(AP-L1898 Capsules) | 40 mg, QD |
| DRUG | JS111(AP-L1898 Capsules) | 80 mg, QD |
| DRUG | JS111(AP-L1898 Capsules) | 160 mg, QD |
| DRUG | JS111(AP-L1898 Capsules) | 240 mg, QD |
| DRUG | JS111(AP-L1898 Capsules) | 320 mg, QD |
Timeline
- Start date
- 2021-07-13
- Primary completion
- 2024-06-18
- Completion
- 2024-08-18
- First posted
- 2021-08-06
- Last updated
- 2022-10-26
Locations
37 sites across 1 country: China
Source: ClinicalTrials.gov record NCT04993391. Inclusion in this directory is not an endorsement.