Clinical trialPhase 1Unknown
A Study of XY0206 in Subjects With Advanced or Metastatic Solid Tumours
A Phase I Open and Multiple Ascending Dose Study to Assess the Safety、Tolerability、Pharmacokinetics and Pharmacodynamic Characteristics of XY0206 in Subjects With Chinese Advanced or Metastatic Solid Tumours
- Outcome
- Outcome unknown
- Phase
- Phase 1
- Status
- Unknown
- Study type
- Interventional
- Start
- 19 December 2018
- Expected end
- December 2020
- Enrollment
- 34 participants
- Sites
- 4
- Primary outcomes
- DLT; AE; ADR; SAE; Blood routine
- Sponsor
- Industry
- Results posted
- No
- Last update
- 21 August 2020
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Brief summary public domain (ClinicalTrials.gov)
1. To observe the safety and tolerability of oral XY0206 in patients with advanced/metastatic malignant solid tumor in China, and observe the drug dose limiting toxicity (DLT) to establish the maximum tolerated dose (MTD) in humans. 2. To investigate the pharmacokinetic (PK) characteristics, pharmacodynamics (PD) characteristics, and PK/PD correlation of single and multiple doses of XY0206 in patients with advanced/metastatic malignant solid tumors to provide dose selection basis for clinical studies; 3. To evaluate the effect of standard meal on main PK parameters of XY0206; 4. To determine the metabolites of XY0206 in patients with advanced/metastatic malignant solid tumor. 5. To explore the correlation between PK and QTcF. 6. Preliminary investigates the effectiveness of XY0206 in patients with advanced/metastatic malignant solid tumors.