RecruitingPhase 1Phase 2NCT04996121

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


Sponsor

Xuanzhu Biopharmaceutical Co., Ltd.

Enrollment

360 participants

Start Date

Dec 6, 2021

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new oral drug called XZP-5955 in patients with advanced or metastatic solid tumors that have a specific genetic change called an NTRK or ROS1 gene fusion — a type of mutation that drives cancer growth and can be targeted by this drug. **You may be eligible if...** - You are 18 or older with confirmed locally advanced or metastatic solid tumor - Your cancer is NTRK or ROS1 fusion positive (confirmed by an approved laboratory) - Your cancer has progressed or stopped responding to available treatments - You are in good health (ECOG 0–1) with at least 3 months life expectancy - You have adequate blood, liver, and kidney function - You are willing to use contraception if of childbearing potential **You may NOT be eligible if...** - You received anti-tumor therapy within 4 weeks before starting the study drug - You have symptomatic brain or spinal cord metastases requiring steroids - You have a known history of immune deficiency or HIV - You have active hepatitis B or C - You have a serious cardiovascular condition - You are pregnant or breastfeeding - You have significant difficulty swallowing or absorbing oral medications Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGXZP-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


Locations(1)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

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NCT04996121


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