A Dose Escalation and Expansion Phase I Study Evaluating the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of TGRX-1942 in Patients with Advanced Solid Tumor And/or Relapsed/Refractory Hematologic Malignancies
A phase I study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of TGRX-1942 in patients with advanced solid tumor and/or relapsed or refractory hematological malignancies
• For dose escalation phase, patient is diagnosed with advanced/metastatic solid tumor who had failed standard therapies and does not have available effective treatment, or who relapsed from prior treatments
• ECOG score of equals to or lower than 1
• Life expectancy of at least 3 months
• Adequate systemic and organ functions, including hematologic, hepatic and kidney functions
• Willing to provide available tumor biopsy sample or reports, or willing to undergo tumor biopsy examination, and willing to partake whole blood sampling for evaluations
• For female of child-bearing potential, willing to undergo plasma pregnancy test 28 days before first dose and have negative results
• Male and Female of child-bearing potential must agree to take effective contraceptive measures during the entire treatment period and for 2 months after the end of treatment
• Understand and willing to sign informed concent; willing and able to complete the visiting schedule and other tasks as required for the study