Actively Recruiting
A Study of XZP-5955 Tablets in Patients With NTRK or ROS1 Fusion Positive Locally Advanced or Metastatic Solid Tumors
Led by Xuanzhu Biopharmaceutical Co., Ltd. · Updated on 2022-08-30
360
Participants Needed
1
Research Sites
286 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study of XZP-5955 Tablets in Patients With NTRK or ROS1 Fusion Positive Locally Advanced or Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older
- Diagnosed with locally advanced or metastatic solid tumor with NTRK or ROS1 gene fusion confirmed by pathology or central laboratory
- For certain cohorts: locally advanced/metastatic solid tumor with NTRK fusion or locally advanced/metastatic NSCLC with ROS1 fusion, with specific prior therapy histories
- At least one measurable target lesion per RECIST 1.1 criteria
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1
- Life expectancy of at least 3 months
- Adequate organ function based on laboratory tests (specific blood counts, liver and kidney function, coagulation parameters)
- Fertile patients agree to use reliable contraception during the trial and for 90 days after last dose
- Women of childbearing potential must have a negative pregnancy test within 7 days before first dose
You will not qualify if you...
- Received anti-tumor therapy (chemotherapy, radiotherapy, biotherapy, endocrine, immunotherapy) within 4 weeks before first dose, with some exceptions
- Received other investigational drugs within 4 weeks before first dose
- Major surgery or significant trauma within 4 weeks before first dose, or requiring elective surgery during study
- Unresolved adverse reactions from prior anti-tumor therapy above grade 1 except specified conditions
- Inability to swallow medication or conditions severely affecting gastrointestinal absorption
- Symptomatic cerebral or meningeal metastases; stable asymptomatic cases allowed with prior treatment at least 1 month ago
- Active infections needing intravenous therapy
- History of immune deficiencies including positive HIV test
- Active Hepatitis B or C infection
- Known interstitial lung disease except stable radioactive pulmonary fibrosis
- History of serious cardiovascular disease
- Pregnant or lactating women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
Actively Recruiting
Research Team
J
Jingjing Dong
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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