Actively Recruiting
Safety and Tolerability Study for T-1201 Injection 100 mg Kit in Patients With Advanced Solid Tumors
Led by Taivex Therapeutics Corporation · Updated on 2025-05-30
40
Participants Needed
2
Research Sites
318 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of T-1201 injection in subjects with advanced solid tumors refractory to standard therapy, or for whom no standard therapy is available. The main questions it aims to answer are: * The Maximum tolerated dose (MTD) of T-1201 on different dosing schedules. * The Recommended Phase 2 dose (RP2D) of T-1201 on different dosing schedules. Researchers will evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of T-1201. Participants will: Received T-1201 either once every 4 (Part A)/2 (Part B)/3 (Part C) weeks, depend on they participate in which parts of study. Visit the clinic once every 2/3 weeks for checkups and tests
CONDITIONS
Official Title
Safety and Tolerability Study for T-1201 Injection 100 mg Kit in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form
- Histologically and cytologically confirmed advanced malignancies refractory to standard therapy or with no accepted standard therapy
- Solid tumors measurable or evaluable by RECIST v1.1 (excluding previously irradiated target lesions)
- Male or female aged 20 years or older
- ECOG performance status of 0 or 1
- QTcF less than or equal to 470 ms at screening
You will not qualify if you...
- Clinically significant comorbidities such as unstable angina, severe heart failure, uncontrolled hypertension, COPD with frequent exacerbations, refractory asthma, inflammatory bowel disease, or intestinal obstruction
- Acute myocardial infarction or stroke within 6 months before first dose
- Central nervous system metastases or seizure disorder due to cancer unless treated and stable or asymptomatic
- AIDS-defining infections within past 12 months
- Active HBV or HCV infection except inactive carriers or undetectable virus cases
- Inadequate bone marrow, liver, or kidney function based on specific lab value thresholds
- Unresolved toxicities from prior treatments except certain mild conditions
- Major surgery within 4 weeks prior to first dose or ongoing post-operative complications
- Receiving any anti-cancer therapy within 28 days or 5 half-lives before first dose
- History of allergic reactions to irinotecan, Tween 80, or ethanol
- Pregnant or breastfeeding females
- Unwillingness to use effective contraception during and after study
- Recent live attenuated vaccine within 28 days before first dose
- Life expectancy less than 3 months
- Other conditions affecting safety, compliance, or study assessment as judged by Investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
Actively Recruiting
2
National Cheng Kung University Hospital
Tainan, Taiwan
Actively Recruiting
Research Team
H
Hsiao-Fang Li, Ph.D
CONTACT
T
TJ Wu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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