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

NCT05650580 | Recruiting Phase 1

• 1 other identifier: TR115-CN-PI-01
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• Adverse events and serious adverse events

  frequency, duration and severity of adverse events and serious adverse events evaluated by NCI CTCAE 5.0

  from the first dose to within 30 days after the last dose

• dose limited toxicities

  incidence of dose limited toxicities

  within 31 days after the first dose

• maximum tolerated dose

  evaluated by safety review committee

  Throughout the study for approximately 2 years

• recommedded phase 2 dose

  evaluated by safety review committee

  Throughout the study for approximately 2 years

Secondary Outcomes (7)

• AUClast

  within 31 days after the first dose

• AUCinf

  within 31 days after the first dose

• Cmax

  within 31 days after the first dose

• Tmax

  within 31 days after the first dose

• CL/F

  within 31 days after the first dose

Other Outcomes (4)

• ORR

  Throughout the study for approximately 2 years

• PFS

  Throughout the study for approximately 2 years

• DOR

  Throughout the study for approximately 2 years

Study Arms (1)

Dose Escalation and Expansion

EXPERIMENTAL

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

Drug: TR115

Interventions

TR115 DRUG

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).

Dose Escalation and Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tarapeutics Science Inc.: lead

Study Sites (1)

The first affiliated hospital, Zhejiang university school of medicine

Hangzhou, Zhejiang, 310003, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Recurrence

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jie Jin, MD, PhD

  Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yang Shu, MD, BS.

CONTACT

+8613918983465; shuyang@tarapeutics.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2022
• First Posted: December 14, 2022
• Study Start: April 23, 2023
• Primary Completion: July 30, 2025
• Study Completion: December 30, 2025
• Last Updated: May 14, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)