A Phase I/II Study of Evaluating the Safety, Tolerance, Pharmacokinetics, Pharmacodynamics and Curative Effect of Dose Escalation and Extension for Single Drug TJ004309 and Toripalimab Combine Treatment for Advanced Solid Tumor

TJ Biopharma Co., Ltd.23 sites in 1 country376 target enrollmentMay 9, 2020

ConditionsAdvanced Solid Tumor

InterventionsTJ004309 Toripalimab

DrugsTJ004309 Toripalimab

Overview

Phase: Phase 1
Intervention: TJ004309
Conditions: Advanced Solid Tumor
Sponsor: TJ Biopharma Co., Ltd.
Enrollment: 376
Locations: 23
Primary Endpoint: Recommend dose of TJ004309
Status: Active, not recruiting
Last Updated: 11 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials Related News

Overview

Brief Summary

This study is a phase I/II study of single drug TJ004309 and Toripalimab combine treatment for Advanced solid tumor. This study include two stages. First stage is dose escalation and second stage is dose extension. The purpose of part A is to confirm the MTD or MED and the clinical dose. The purpose of part B is to observe the safety, effectiveness, Pharmacokinetics, pharmacodynamics and biomarker properties for effective subjects.

Registry

clinicaltrials.gov

Start Date

May 9, 2020

End Date

December 30, 2025

Last Updated

11 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

TJ Biopharma Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age ≥ 18 years
•Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1
•In the dose-escalation phase, subjects with advanced solid tumors that are histologically or cytologically confirmed to be unresectable or have metastasized, subjects with standard treatment failure or intolerance (disease progression, or inability to tolerate chemotherapy, targeted therapy, etc.), or subjects without effective treatment.
•Synchronous dose expansion (will base on dose-escalation phase)
•At least one measurable disease by modified RECIST 1.1 for immune based therapeutics V1.1
•Expected survival ≥ 3 months
•Adequate organ function as defined by the following criteria:
•Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≤ 2.5 times upper limit of normal (ULN)
•Total serum bilirubin ≤ 1.5 times the ULN
•Absolute neutrophil count (ANC) ≥ 1.5 ×109/ L

Exclusion Criteria

•Pregnancy or breastfeeding
•Prior T-cell therapy
•Receipt of systemic anticancer therapy or ≥ 5 times the elimination half-life of the drug has elapsed within 2 weeks prior to study treatment (Note: whichever is shorter shall prevail.)
•Exist ≥ 2 kinds of primary tumor, expect cured preinvasive carcinoma and basaloma. (patients are not excluded if ≥ 5 years treatment with other tumor prior to study treatment.)
•Autoimmune disease requiring treatment within the past twelve months only requiring related treatment replacement
•Condition requiring systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalent) or other immunosuppressive medications more than 7 days within 14 days prior to study treatment (Note: inhaled and topical steroids, and adrenal replacement steroid doses \> 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.)
•Current treatment on another therapeutic clinical trial within 14 days prior to study treatment
•Major surgical procedure or significant traumatic injury within 4 weeks prior to study treatment and no date of surgery (if applicable) or anticipated need for a major surgical procedure planned during study treatment
•Chest radiotherapy ≤ 4 weeks, wide field radiotherapy ≤ 4 weeks (defined as \> 50% of volume of pelvic bones or equivalent) or palliative radiotherapy ≤ 2 weeks prior to study treatment
•Brain involvement with cancer, spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease, unless the lesion(s) have been radiated or resected, are considered fully treated and inactive, are asymptomatic, and no steroids have been administered for central nervous system disease over the 2 weeks prior to study treatment