Actively Recruiting
The Safety, Pharmacokinetics, and Efficacy 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
91 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, pharmacokinetics, and effectiveness of XZP-5955 tablets in patients who have advanced solid tumors with specific gene fusions called NTRK or ROS1. This study is a combined phase I/II trial that focuses on patients with locally advanced or metastatic solid tumors where these gene fusions are present. The trial is conducted by Xuanzhu Biopharmaceutical Co., Ltd. and aims to better understand how this drug behaves in the body and its potential impact on tumor response. Participants will receive XZP-5955 tablets orally. In phase I dose escalation, the drug is given as a single dose on day 1 and then daily from day 4 in 21-day cycles. During phase I dose expansion and phase II, patients take the tablets once daily continuously in 21-day cycles. Some patients will have additional blood samples taken to study how the drug is processed in the body. The study does not use a comparison group or placebo. Throughout the trial, participants will undergo regular assessments including scans to measure tumor size, blood tests to monitor drug levels and organ function, and evaluations for side effects. The main outcomes measured include the highest safe dose, frequency of adverse events, and the overall response rate of tumors over 2 to 3 years after starting treatment. Long-term follow-up will also look at progression-free survival, duration of response, and overall survival. Safety and drug effects will be closely monitored during and after treatment.
CONDITIONS
Brief 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 subjects aged 18 years or older
- Diagnosed with locally advanced or metastatic solid tumors confirmed by histology or cytology
- For phase I dose escalation: No standard therapy available or tumor is relapsed, progressed, nonresponsive, intolerant, or unsuitable to standard therapy
- For phase I dose expansion and phase II: Tumors must test positive for NTRK or ROS1 gene fusion confirmed by a qualified laboratory
- Specific cohorts include patients with NTRK gene fusion or ROS1 gene fusion with various prior treatment statuses
- At least one measurable target lesion according to RECIST version 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy of 3 months or more
- Adequate organ function based on specified laboratory values
- Fertile patients must agree to use reliable contraception during the trial and for 90 days after last dose; women of childbearing age must have a negative pregnancy test within 7 days before starting treatment
You will not qualify if you...
- Received chemotherapy, radiotherapy, biotherapy, endocrine therapy, immunotherapy, or other anti-tumor therapy within 4 weeks before starting study drug, with some exceptions
- Received other investigational drugs within 4 weeks before study drug
- Major organ surgery or significant trauma within 4 weeks before study drug or requiring surgery during trial
- Unresolved adverse reactions from prior anti-tumor therapy above grade 1 (except some stable conditions)
- Unable to swallow drug or conditions affecting gastrointestinal absorption
- Symptomatic cerebral or meningeal metastases requiring steroid treatment within 4 weeks; certain asymptomatic cases allowed
- Active infections requiring intravenous antibiotics
- History of immune deficiencies including positive HIV
- Active Hepatitis B or C infection
- Known interstitial lung disease (except stable radiation-induced fibrosis)
- History of serious cardiovascular disease
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 21-day cycles until disease progression or discontinuation
Participants receive oral XZP-5955 tablets once daily in continuous cycles of 21 consecutive days each. In Phase I dose escalation, dosing starts with a single dose on Day 1 followed by daily doses from Day 4. Treatment continues through Phase I dose expansion and Phase II according to protocol.
Visits occur throughout treatment cycles as scheduled for dosing and assessments
Duration - Up to 30 days after last dose for safety monitoring; efficacy outcomes assessed up to 2 to 3 years after first dose
Participants are monitored for safety and treatment outcomes after stopping XZP-5955 tablets.
Approximately 1 to 2 visits within 30 days post-treatment; long-term assessments as scheduled
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
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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