Trials / Recruiting
RecruitingNCT04996121
A Study of XZP-5955 Tablets in Patients With NTRK or ROS1 Fusion Positive Locally Advanced or Metastatic Solid Tumors
The Safety Tolerability Pharmacokinetic Characteristics and Efficacy of XZP-5955 Tablets in Patients With NTRK or ROS1 Gene Fusion Locally Advanced or Metastatic Solid Tumors in a Single-arm Open-label Multi-center Phase I/II Clinical Study
- Status
- Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 360 (estimated)
- Sponsor
- Xuanzhu Biopharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
A phase I/II study to examine the safety, tolerability, pharmacokinetics and efficacy of XZP-5955 tablets in patients with advanced solid tumors harboring NTRK or ROS1 gene fusion
Conditions
- Locally Advanced or Metastatic Solid Tumors
- Locally Advanced or Metastatic Non-small Cell Lung Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | XZP-5955 tablets | Phase I dose escalation: For each dose cohort, XZP-5955 tablet will be administered orally, single dose for day 1 and then from day 4, administered for continuous cycles of 21 consecutive days for each cycle Phase I dose expansion: XZP-5955 tablet will be administered orally, once daily for continuous cycles of 21 consecutive days for each cycle. Some patients for PK sample collection, the drug will be administered single dose for day 1, then from day 4, administered for continuous cycles of 21 consecutive days for each cycle Phase II: XZP-5955 tablet will be administered orally, once daily for continuous cycles of 21 consecutive days for each cycle |
Timeline
- Start date
- 2021-12-06
- Primary completion
- 2025-09-01
- Completion
- 2027-06-01
- First posted
- 2021-08-09
- Last updated
- 2022-08-30
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04996121. Inclusion in this directory is not an endorsement.