TGRX-1942 Chinese Phase I for Advanced Solid Tumor And/or Relapsed/Refractory Hematologic Malignancies
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorShenzhen TargetRx Co., Ltd.
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Allergic to any of the ingredient of the investigational drug
History of other primary malignancies
Have adverse/toxic effects from previous treatment that has not recovered to CTCAE 5.0 <= Grade 1
Received other anti-tumor treatments (i.e., chemotherapy, biologics, immunotherapy, targeted therapy, etc.) 28 days before first dose, or radiation therapy 14 days before first dose
Trial design
Design model
Single group
Treatments tested in this trial
TGRX-1942
DrugAt dose escalation phase, TGRX-1942 will be given orally to patient once a day under a 7-dose sequence of 4mg, 10mg, 20mg, 30mg, 40mg, 50mg, and 60mg. The dose level a particular patient will be assigned depends on the progression of the study and PI evaluation on the safety of previous dose group(s).
Treatment groups
90 Participants
are divided into 1 treatment groupGroup A: Experimental: TGRX-1942Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
From screening through completion of the study, an average of 3.5 years.2
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.
Time frame
From Day 1 of Cycle 1 to Day 28 of Cycle 1 of dose escalation phase (each cycle is 28 days)Secondary outcomes
1
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.
Time frame
From screening, every 3 cycles during treatment period (each cycle is 28 days) and at end of study, an average of 3.5 years.2
Time to Maximum Concentration (Tmax)
To measure the time to reach maximum plasma drug concentration from dosing
Time frame
On day 1-6 of the single dosing phase; patient will only be dosed once on Day 1 of this phase3
Maximum Concentration (Cmax)
To measure the maximum plasma drug concentration from dosing
Time frame
On day 1-6 of the single dosing phase; patient will only be dosed once on Day 1 of this phase4
Area Under Curve (AUC0-t)
To calculate area under curve of drug plasma concentration from dosing to last measurable time point
Time frame
On day 1-6 of the single dosing phase; patient will only be dosed once on Day 1 of this phaseSponsors and contacts
Click on the lead sponsor to view all of their trials.
Shenzhen TargetRx Co., Ltd.
Lead sponsor
Sir Run Run Shaw Hospital
Collaborator
Source ClinicalTrials.gov