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TR115 in Patients With Relapsed / Refractory Non-Hodgkin's Lymphoma or Advanced Solid Tumors

Primary Purpose

Non-Hodgkin's Lymphoma, Relapsed, Non-Hodgkin's Lymphoma Refractory, Advanced Solid Tumor

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
TR115
Sponsored by
Tarapeutics Science Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Hodgkin's Lymphoma, Relapsed

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key 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. tumor type criteria: relapsed/refractory histologically or cytologically documented non-hodgkin's lymphoma must have received at least 1 prior systemic therapies, including but not limited as below: Follicular Lymphoma (FL), Diffuse Large B-cell Lymphoma (DLBCL), Peripheral T-cell lymphoma-Not Otherwise Specified (PTCL-NOS), Angioimmunoblastic T-cell Lymphoma (AITL), Anaplastic Large Cell Lymphoma (ALCL). 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. eastern cooperative oncology group performance status (ECOG) ≤2 at screening. life expectancy of at least 3 months. acceptable organ function: absolute neutrophil count (ANC)≥1.0×109/L (note: growth factor supports within 14 days of the first dose); platelet count (PLT)≥90×109/L (note: PLT≥70 × 109/L for patients with Non-Hodgkin Lymphoma (NHL) and ≥50 × 109/L allowed in patients with bone marrow infiltration. no blood product transfusion is allowed within 14 days of the first dose); hemoglobin (Hb) ≥90g/L (note: Hb ≥80g/L for patients with NHL and ≥70g/L in patients with bone marrow infiltration. no blood product transfusion is allowed within 14 days of the first dose); 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×ULN, Aspartate Amino Tranferase (AST) and Alanine Transaminase (ALT)≤2.5×ULN (note: ≤ 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. Key Exclusion Criteria: known or suspected allergies to any of the investigational drug compositon. 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). subjects may not be able to complete the study due to poor compliance or other reasons, or unsuitable for the study by the investigator's judgment.

Sites / Locations

  • The first affiliated hospital, Zhejiang university school of medicineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dose Escalation and Expansion

Arm Description

Participants with relapsed/Refractory Non-Hodgkin's Lymphoma or Advanced solid tumor will receive TR115 at escalating and expansion dose levels.

Outcomes

Primary Outcome Measures

Adverse events and serious adverse events
frequency, duration and severity of adverse events and serious adverse events evaluated by NCI CTCAE 5.0
dose limited toxicities
incidence of dose limited toxicities
maximum tolerated dose
evaluated by safety review committee
recommedded phase 2 dose
evaluated by safety review committee

Secondary Outcome Measures

AUClast
characterize the pharmacokinetic profile of TR115
AUCinf
characterize the pharmacokinetic profile of TR115
Cmax
characterize the pharmacokinetic profile of TR115
Tmax
characterize the pharmacokinetic profile of TR115
CL/F
characterize the pharmacokinetic profile of TR115
Vz/F
characterize the pharmacokinetic profile of TR115
Terminal half-life (T1/2)
characterize the pharmacokinetic profile of TR115

Full Information

First Posted
December 6, 2022
Last Updated
April 22, 2023
Sponsor
Tarapeutics Science Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05650580
Brief Title
TR115 in Patients With Relapsed / Refractory Non-Hodgkin's Lymphoma or Advanced Solid Tumors
Official Title
A Phase I Clinical Study to Characterize Safety, Tolerability, and Pharmacokinetics of TR115 in Patients With Relapsed / Refractory Non-Hodgkin's Lymphoma or Advanced Solid Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 23, 2023 (Actual)
Primary Completion Date
July 30, 2024 (Anticipated)
Study Completion Date
January 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tarapeutics Science Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
A phase 1 dose escalation and expanded cohort study of TR115 in the treatment of adult patients with relapsed/refractory non-hodgkin's lymphoma or advanced solid tumors.
Detailed Description
This is a open-label, dose escalation and expansion, accelerated titration combined 3+3 design, phase 1 study, to evaluate the safety and tolerability, and to determine the Recommeded Phase II Dose (RP2D) of TR115 when administered bid in patients with non-hodgkin's lymphoma or advanced solid tumors. During the dose escalation phase, Up to 6 cohorts of 1-6 0r 3-6 patients each will be treated in the study. Patients will receive study treatment until criteria for study termination are met. A safety Follow-up Visit will conducted 30 days (±7 days) after the last dose of treatment. Patients who discontinue study treatment for reasons other than disease progression will have post-treatment follow-up for disease assessment until start of new anticancer treatment, lost to follow-up, death, or until the sponsor stops the study, whichever comes first. After finishing the dose escalation phase, a dose extension phase will be initiated with additional patients included in order to further evaluate the tolerability, pharmacokinetics, and efficacy at the recommended dose that have been evaluated in the dose escalation phase. Adverse events 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 Lugano 2014/RECIST 1.1 criteria, assessed by the investigator.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Hodgkin's Lymphoma, Relapsed, Non-Hodgkin's Lymphoma Refractory, Advanced Solid Tumor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dose Escalation and Expansion
Arm Type
Experimental
Arm Description
Participants with relapsed/Refractory Non-Hodgkin's Lymphoma or Advanced solid tumor will receive TR115 at escalating and expansion dose levels.
Intervention Type
Drug
Intervention Name(s)
TR115
Intervention Description
TR115 is supplied as tablet with dosage strength of 100mg. TR115 tablet will be administered orally on a continuous twice daily (BID) schedule and a treatment cycle is defined as 28 days for the purposes of scheduling procedures and evaluations. TR115 tablets will be given until there appears evidence of progressive disease , intolerable toxicity, or the subject discontinues from the study treatment for other reasons. Proposed daily dose (BID): 100mg, 200mg, 400mg, 800mg, 1200mg, 1600mg. It is possible for additional and/or intermediate dose levels to be added during the course of the study. Cohorts may be added at any dose level below the Maximum Tolerated Dose (MTD) in order to better understand safety, Pharmacokinetic (PK) or Pharmacodynamic (PD).
Primary Outcome Measure Information:
Title
Adverse events and serious adverse events
Description
frequency, duration and severity of adverse events and serious adverse events evaluated by NCI CTCAE 5.0
Time Frame
from the first dose to within 30 days after the last dose
Title
dose limited toxicities
Description
incidence of dose limited toxicities
Time Frame
within 31 days after the first dose
Title
maximum tolerated dose
Description
evaluated by safety review committee
Time Frame
Throughout the study for approximately 2 years
Title
recommedded phase 2 dose
Description
evaluated by safety review committee
Time Frame
Throughout the study for approximately 2 years
Secondary Outcome Measure Information:
Title
AUClast
Description
characterize the pharmacokinetic profile of TR115
Time Frame
within 31 days after the first dose
Title
AUCinf
Description
characterize the pharmacokinetic profile of TR115
Time Frame
within 31 days after the first dose
Title
Cmax
Description
characterize the pharmacokinetic profile of TR115
Time Frame
within 31 days after the first dose
Title
Tmax
Description
characterize the pharmacokinetic profile of TR115
Time Frame
within 31 days after the first dose
Title
CL/F
Description
characterize the pharmacokinetic profile of TR115
Time Frame
within 31 days after the first dose
Title
Vz/F
Description
characterize the pharmacokinetic profile of TR115
Time Frame
within 31 days after the first dose
Title
Terminal half-life (T1/2)
Description
characterize the pharmacokinetic profile of TR115
Time Frame
within 31 days after the first dose
Other Pre-specified Outcome Measures:
Title
ORR
Description
efficacy-overall response rate
Time Frame
Throughout the study for approximately 2 years
Title
PFS
Description
efficacy-progression free survival
Time Frame
Throughout the study for approximately 2 years
Title
DOR
Description
efficacy-duration of response
Time Frame
Throughout the study for approximately 2 years
Title
CBR
Description
efficacy--clinical benefit rate
Time Frame
Throughout the study for approximately 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key 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. tumor type criteria: relapsed/refractory histologically or cytologically documented non-hodgkin's lymphoma must have received at least 1 prior systemic therapies, including but not limited as below: Follicular Lymphoma (FL), Diffuse Large B-cell Lymphoma (DLBCL), Peripheral T-cell lymphoma-Not Otherwise Specified (PTCL-NOS), Angioimmunoblastic T-cell Lymphoma (AITL), Anaplastic Large Cell Lymphoma (ALCL). 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. eastern cooperative oncology group performance status (ECOG) ≤2 at screening. life expectancy of at least 3 months. acceptable organ function: absolute neutrophil count (ANC)≥1.0×109/L (note: growth factor supports within 14 days of the first dose); platelet count (PLT)≥90×109/L (note: PLT≥70 × 109/L for patients with Non-Hodgkin Lymphoma (NHL) and ≥50 × 109/L allowed in patients with bone marrow infiltration. no blood product transfusion is allowed within 14 days of the first dose); hemoglobin (Hb) ≥90g/L (note: Hb ≥80g/L for patients with NHL and ≥70g/L in patients with bone marrow infiltration. no blood product transfusion is allowed within 14 days of the first dose); 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×ULN, Aspartate Amino Tranferase (AST) and Alanine Transaminase (ALT)≤2.5×ULN (note: ≤ 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. Key Exclusion Criteria: known or suspected allergies to any of the investigational drug compositon. 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). subjects may not be able to complete the study due to poor compliance or other reasons, or unsuitable for the study by the investigator's judgment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yang Shu, MD, BS.
Phone
+8613918983465
Email
shuyang@tarapeutics.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jie Jin, MD, PhD
Organizational Affiliation
Zhejiang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The first affiliated hospital, Zhejiang university school of medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jie Jin, MD Ph.D
Phone
0571-87236898
Email
jiej0503@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

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TR115 in Patients With Relapsed / Refractory Non-Hodgkin's Lymphoma or Advanced Solid Tumors

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