TR64 in Patients With Advanced Solid Tumors
ConditionAdvanced Solid Tumor
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorTarapeutics Science Inc.
About this trial
This is a open-label, dose escalation, accelerated titration combined 3+3 design, phase I study, to evaluate the safety and tolerability, and to determine the RP2D of TR64 when administered qd in patients with advanced solid tumors. Up to 6 cohorts of 1-6 or 3-6 patients each will be treated in the study.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Fully understand the procedures of the clinical study and participate voluntarily with signed and dated written informed consent form, comply with the requirements of the study protocol.
Males and/or females at least 18 years old when signing the informed consent form.
Histologically or cytologically confirmed patients with advanced malignant solid tumors, eligible patients must have failed standard treatment, no standard treatment, or not suitable for standard treatment at this stage as determined by the investigator.
Measurable disease with at least one lesion amenable to response assessment per RECIST 1.1.
Disqualifiers
Known or suspected allergies to any of the investigational drug composition.
Medical history and surgical history excluded according to the protocol.
Any previous medical treatment history exclude from the protocol.
Abnormal laboratory results exclude from the protocol.
Trial design
Design model
Single group
Treatments tested in this trial
TR64
DrugTR64 tablets will be given daily for 28 days in 28-day cycles until there appears evidence of progressive disease, intolerable toxicity, or the subject discontinues from the study treatment for other reasons.
Treatment groups
19 Participants
are divided into 1 treatment groupGroup A: TR64Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Adverse Events and Serious Adverse Events
Frequency, duration and severity of Adverse Events and Serious Adverse Events evaluated by NCI CTCAE v5.0
Time frame
From the first dose to within 28 days after the last dose2
Dose limited toxicities
Incidence of dose limited toxicities
Time frame
within 28 days after the first dose3
Maximum tolerated dose
Evaluated by safety review committee
Time frame
Throughout the study for approximately 2 years4
Recommended phaseII dose
Evaluated by safety review committee
Time frame
Throughout the study for approximately 2 yearsSecondary outcomes
1
AUClast
Characterize the pharmacokinetic profile of TR64
Time frame
within 35 days after the first dose2
AUCinf
Characterize the pharmacokinetic profile of TR64
Time frame
within 35 days after the first dose3
Cmax
Characterize the pharmacokinetic profile of TR64
Time frame
within 35 days after the first dose4
Tmax
Characterize the pharmacokinetic profile of TR64
Time frame
within 35 days after the first doseOther outcomes
1
ORR
Efficacy-Overall Response Rate
Time frame
Throughout the study for approximately 2 years2
PFS
Efficacy-Progression Free Survival
Time frame
Throughout the study for approximately 2 years3
DOR
Efficacy-Duration of Response
Time frame
Throughout the study for approximately 2 years4
CBR
Efficacy-Clinical Benefit Rate
Time frame
Throughout the study for approximately 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov