TGRX-1942 Chinese Phase I for Advanced Solid Tumor and/or Relapsed/Refractory Hematologic Malignancies
NCT Number: NCT06484816
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Non Small Cell Lung Cancer|Advanced Solid Tumor|Hematologic Malignancy
Interventions: DRUG: TGRX-1942
Sponsor: Shenzhen TargetRx, Inc.
Collaborators: Sir Run Run Shaw Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 90
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-31
Completion Date: 2027-08-31

Summary:
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

Primary Outcome Measures: Adverse events/serious adverse events, to record and analyse the occasions and rates of subjects with adverse events (AEs) and serious adverse events (SAEs) to understand drug safety profile, From screening through completion of the study, an average of 3.5 years.|Maximum Tolerated Dose (MTD), MTD is defined as the dose level with dose-limiting toxicity (DLT) rate of greater than 0.322 as calculated using the BOIN design at dose escalation phase., From Day 1 of Cycle 1 to Day 28 of Cycle 1 of dose escalation phase (each cycle is 28 days)
Secondary Outcome Measures: Preliminary efficacy, For patients with advanced solid tumors, efficacy is evaluated based on RECIST 1.1 criteria which evaluates tumor size changes. Preliminary efficacy is evaluated by Principal investigator., From screening, every 3 cycles during treatment period (each cycle is 28 days) and at end of study, an average of 3.5 years.|Time to Maximum Concentration (Tmax), To measure the time to reach maximum plasma drug concentration from dosing, On day 1-6 of the single dosing phase; patient will only be dosed once on Day 1 of this phase|Maximum Concentration (Cmax), To measure the maximum plasma drug concentration from dosing, On day 1-6 of the single dosing phase; patient will only be dosed once on Day 1 of this phase|Area Under Curve (AUC0-t), To calculate area under curve of drug plasma concentration from dosing to last measurable time point, On day 1-6 of the single dosing phase; patient will only be dosed once on Day 1 of this phase|Half life (T1/2), to measure the time needed to reach half maximal concentration from dosing, On day 1-6 of the single dosing phase; patient will only be dosed once on Day 1 of this phase|Apparent Clearance (CL/F), To calculate the rate of clearance of the drug after first dosing, On day 1-6 of the single dosing phase; patient will only be dosed once on Day 1 of this phase|Apparent Volume of Distribution (Vz/F), To calculate the volume of distribution of the drug after first dosing, On day 1-6 of the single dosing phase; patient will only be dosed once on Day 1 of this phase|Steady State Time to Maximal Concentration (Tmax,ss), Under once daily dosing schedule, to measure the time to reach maximum plasma drug concentration between two dosing timepoints, On day 1 of Cycle 1 of dose escalation phase (each cycle is 28 days)|Steady State Maximal Concentration (Cmax,ss), Under once daily dosing schedule, to measure the maximal plasma drug concentration from first dosing, On Day 1, 8, 15 and 22 of Cycle 1 and Day 1 of every 3 cycles (each cycle is 28 days). Average duration of the treatment period is 3 years.|Steady State Trough Concentration (Ctrough,ss), Under once daily dosing schedule, to measure the minimal plasma drug concentration from first dosing, On Day 1, 8, 15 and 22 of Cycle 1 and Day 1 of every 3 cycles (each cycle is 28 days). Average duration of the treatment period is 3 years.|Steady State Area Under Curve (AUC0-t,ss), Under once daily dosing schedule, to calculate area under curve of drug plasma concentration between two dosing timepoints, On Day 1, 8, 15 and 22 of Cycle 1 and Day 1 of every 3 cycles (each cycle is 28 days). Average duration of the treatment period is 3 years.