Actively Recruiting
TR128 in Patients With Advanced Solid Tumors
Led by Tarapeutics Science Inc. · Updated on 2024-05-14
50
Participants Needed
3
Research Sites
96 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a open-label, 3+3 design, dose escalation and expansion, phase I study, to evaluate the safety and tolerability, and to determine the Recommended Phase II Dose (RP2D) of TR128 when administered qd in patients with advanced solid tumors. Up to 5 cohorts of 3-6 patients each will be treated in dose escalation phase of the study. One cycle is 28 days. Dose expansion phase to further evaluate the safety, tolerability and preliminary anti-tumor activity of TR128 at the RP2D.
CONDITIONS
Official Title
TR128 in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Understand and voluntarily agree to participate with signed informed consent
- Male or female at least 18 years old
- Histologically or cytologically confirmed advanced malignant solid tumors
- Failed standard treatment, no standard treatment, or unsuitable for standard treatment
- Measurable disease with at least one lesion assessable by RECIST 1.1
- ECOG performance status 0 or 1
- Life expectancy of at least 3 months
- Acceptable organ function including neutrophils, platelets, hemoglobin, coagulation, liver and kidney function
- Agree to use medically approved contraceptives during study and 6 months after last dose (if fertile)
You will not qualify if you...
- Medical or surgical history excluding participation as defined by protocol
- Previous medical treatment history excluding participation as defined by protocol
- Abnormal laboratory results excluding participation as defined by protocol
- Pregnant or breastfeeding women (currently or within 6 months after delivery)
- Judged unsuitable for the study by the investigator
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
2
Harbin Medical University Cancer Hospital
Harbin, Heilonjiang, China, 150081
Actively Recruiting
3
Tianjin Medical University Cancer Institute&Hospital
Tianjin, Tianjin Municipality, China, 300060
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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