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
Qualifiers
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
Treatments tested in this trial
- TR64
Treatment groups
19 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov