- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05751356
TR128 in Patients With Advanced Solid Tumors
A Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of TR128 in Patients With Advanced Solid Tumors
Study Overview
Detailed Description
This phase I study of TR128 will investigate the tolerability, safety, pharmacokinetics (PK) and preliminary efficacy of TR128, and will define the maximum tolerated dose (MTD) of TR128 using 3+3 design. A dose expansion phase will identify the recommended phase 2 dose. In this clinical study, TR128 is given orally daily. A treatment cycle is defined as 28 days. Patients will receive study treatment until criteria for study termination are met. A safety follow-up visit will be conducted 28 days after the last dose of study treatment. Patients who discontinue study treatment for reasons other disease progression will have post-treatment follow-up for disease assessment until start of new anticancer treatment, patient withdraws consent, is lost to follow-up, death, or until the sponsor stops the study, whichever comes first.
Adverse events (AEs) will be assessed using the NCI Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0.
Tumor response will be assessed by computed tomography (CT) and /or magnetic resonance imaging (MRI) scan using RECIST1.1 criteria, assessed by the investigator.
Study Type
Enrollment (Estimated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Yang Shu, MD. BS.
- Phone Number: +8613918983465
- Email: shuyang@tarapeutics.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
- eastern cooperative oncology group performance status (ECOG) ≤1 at screening.
- life expectancy of at least 3 months.
- acceptable organ function: Absolute neutrophil count(ANC)≥1.5×109/L; Platelet count(PLT)≥90×109/L; Hemoglobin(Hb)≥90 g/L; International Normalized Ratio (INR) or Prothrombin Time (PT)≤1.5×Upper limit of normal value (ULN), Activated Partial Thromboplastin Time (APTT)≤1.5×ULN ; Total bilirubin(TBIL)≤1.5×Upper limit of normal value(ULN) (≤3× ULN if there is liver involvement); Alanine aminotransferase(ALT)≤2.5×ULN and aspartate aminotransferase(AST)≤2.5×ULN (≤ 5 × ULN if there is liver involvement); Creatinine (Cr) ≤1.5×ULN or Creatinine Clearance (CCr) ≥50 ml/min (calculated by Cockcroft-Gault formula).
- fertile male and female must agree to use medically approved contraceptives during the study and within 6 months after the last dose of the study.
Exclusion Criteria:
- 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.
- pregnant and lactating women (currently breast-feeding or less than six months after delivery although not breast-feeding).
- unsuitable for the study by the investigator's judgment.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: TR128
|
TR128 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.
Starting dose is 100mg, with escalation to 500mg.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dose limited toxicities
Time Frame: within 28 days after the first dose
|
Incidence of dose limited toxicities
|
within 28 days after the first dose
|
Maximum tolerated dose
Time Frame: Throughout the study for approximately 2 years
|
Evaluated by safety review committee
|
Throughout the study for approximately 2 years
|
Adverse Events and Serious Adverse Events
Time Frame: from the first dose to within 30 days after the last dose
|
Frequency, duration, and severity of Adverse Events and Serious Adverse Events evaluated by NCI CTCAE v5.0
|
from the first dose to within 30 days after the last dose
|
Recommended phase II dose
Time Frame: Throughout the study for approximately 2 years
|
Evaluated by safety review committee
|
Throughout the study for approximately 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
AUClast
Time Frame: within 31 days after the first dose
|
Characterize the pharmacokinetic profile of TR128
|
within 31 days after the first dose
|
Tmax
Time Frame: within 31 days after the first dose
|
Characterize the pharmacokinetic profile of TR128
|
within 31 days after the first dose
|
Vz/F
Time Frame: within 31 days after the first dose
|
characterize the pharmacokinetic profile of TR128
|
within 31 days after the first dose
|
ORR
Time Frame: throughout the study for approximately 2 years
|
Efficacy-overall response rate
|
throughout the study for approximately 2 years
|
PFS
Time Frame: throughout the study for approximately 2 years
|
Efficacy-progression free survival
|
throughout the study for approximately 2 years
|
DOR
Time Frame: throughout the study for approximately 2 years
|
Efficacy-duration of response
|
throughout the study for approximately 2 years
|
AUCinf
Time Frame: within 31 days after the first dose
|
Characterize the pharmacokinetic profile of TR128
|
within 31 days after the first dose
|
Cmax
Time Frame: within 31 days after the first dose
|
Characterize the pharmacokinetic profile of TR128
|
within 31 days after the first dose
|
CL/F
Time Frame: within 31 days after the first dose
|
Characterize the pharmacokinetic profile of TR128
|
within 31 days after the first dose
|
Terminal half-life (T1/2)
Time Frame: within 31 days after the first dose
|
Characterize the pharmacokinetic profile of TR128
|
within 31 days after the first dose
|
DCR
Time Frame: throughout the study for approximately 2 years
|
Efficacy-disease control rate
|
throughout the study for approximately 2 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lin Shen, MD, PhD, Peking University Cancer Hospital & Institute
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TR128-CN-PI-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Advanced Solid Tumor
-
Impact Therapeutics, Inc.RecruitingSolid Tumor | Advanced Solid TumorChina, Taiwan, United States, Australia
-
Aadi Bioscience, Inc.RecruitingAdvanced Solid Tumor | Tumor | Tumor, SolidUnited States
-
Pyxis Oncology, IncRecruiting
-
Neurogene Inc.Merck Sharp & Dohme LLCActive, not recruitingSolid Tumor | Advanced Solid TumorUnited States, Australia, Canada
-
EMD Serono Research & Development Institute, Inc.Merck KGaA, Darmstadt, GermanyCompletedSolid Tumor | Advanced Solid TumorSpain, United States, Netherlands, United Kingdom
-
BeiGeneRecruitingSolid Tumor | Advanced Solid TumorUnited States, New Zealand, Australia, China
-
Zhuhai Yufan Biotechnologies Co., LtdRecruitingAdvanced Solid Tumor | Advanced Solid MalignanciesChina
-
Zhuhai Yufan Biotechnologies Co., LtdRecruitingAdvanced Solid Tumor | Advanced Solid MalignanciesUnited States
-
Jazz PharmaceuticalsMerck Sharp & Dohme LLCRecruitingAdvanced Solid Tumor | Metastatic Solid TumorUnited States
-
PharmaEngineNot yet recruitingAdvanced Solid Tumor | Metastatic Solid Tumor