Actively Recruiting
TR64 in Patients With Advanced Solid Tumors
Led by Tarapeutics Science Inc. · Updated on 2024-05-14
19
Participants Needed
2
Research Sites
206 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
TR64 in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Fully understand the study procedures and agree to participate voluntarily with signed informed consent
- Male or female patients aged 18 years or older at the time of consent
- Histologically or cytologically confirmed advanced malignant solid tumors with failed, no, or unsuitable standard treatments
- Have measurable disease with at least one lesion assessable by RECIST 1.1 criteria
- Eastern Cooperative Oncology Group performance status of 0, 1, or 2 at screening
- Life expectancy of at least 3 months
- Acceptable organ function: ANC 61.5 x 10 9/L; platelet count 6590 x 10 9/L; hemoglobin 6590 g/L; total bilirubin 641.5 times upper limit normal; ALT and AST 642.5 times upper limit normal; creatinine clearance 6550 ml/min
- Fertile males and females must agree to use medically approved contraception during the study and for 90 days after the last dose
You will not qualify if you...
- Known or suspected allergies to any component of the investigational drug
- Medical or surgical history that excludes participation per protocol
- Previous medical treatments excluded by the protocol
- Abnormal laboratory results excluding participation per protocol
- Pregnant or lactating women (currently breastfeeding or within 6 months after delivery if not breastfeeding)
- Inability to complete the study due to poor compliance or other reasons, or judged unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China, 233004
Actively Recruiting
2
The First Hospital of China Medical University
Shenyang, Liaoning, China, 110002
Actively Recruiting
Research Team
Y
Yang Shu, MD. BS.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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