A Phase I/II Study of TJ004309 for Advanced Solid Tumor

NCT04322006 | Active Not Recruiting Phase 1

• 1 other identifier: TJ004309STM102
• Study Type: interventional
• Target: 376
• Locations: 1 country
• Sites: 23

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.

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (4)

• Dose Limiting Toxicities(DLT)

  The safety and tolerance of TJ004309

  28days after first dose for QW, 21days after first dose for Q3W

• MTD

  Maximum tolerated dose (MTD)

  2 years

• MED

  Maximum effective dose (MED)

  2 years

• Recommend dose of TJ004309

  Recommend dose of TJ004309

  2 years

Study Arms (1)

TJ004309 injection Monotherapy or Combination with Toripalimab

EXPERIMENTAL

TJ004309 will be dose escalated in a 3+3 design in Monotherapy or combination with Toripalimab

Drug: TJ004309; Drug: Toripalimab

Interventions

TJ004309 DRUG

Antibody to CD73

TJ004309 injection Monotherapy or Combination with Toripalimab

Toripalimab DRUG

Humanized monoclonal antibody to PD-1

TJ004309 injection Monotherapy or Combination with Toripalimab

Eligibility Criteria

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

You may qualify if:

• 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
• Platelets ≥ 100×109/ L without transfusion support within 28 days prior to study treatment
• Hemoglobin ≥ 9.0 g/dL without transfusion support within 14 days prior to study treatment
• Serum creatinine ≤ 1.5 times the ULN or Creatinine clearance \> 30 mL/min by Cockcroft-Gault formula
• International normalized ratio (INR) in normal range
• Serum pregnancy test must be negative for childbearing female prior to study treatment

You may not qualify if:

• 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
• Known active viral or nonviral hepatitis or cirrhosis, except patients with Hepatitis C infection and undetectable virus following treatment are eligible.
• Known human immunodeficiency virus (HIV) positive
• Ascites or pericardial effusion that can not be control
• History of or active interstitial lung disease
• Hypertension is not well controlled by medication. Hypertension defined as blood pressure (BP) systolic \> 150 or diastolic \> 90 mm Hg (Note: Initiation or adjustment of antihypertensive medication prior to study entry is allowed provided that the average of the three most recent BP readings prior to study enrollment is ≤150/90 mm Hg.)

Sponsors & Collaborators

• TJ Biopharma Co., Ltd.: lead

Study Sites (23)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Location

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Location

Army Medical Center of PLA

Chongqing, Chongqing Municipality, China

Location

Chongqing Cancer Hospital

Chongqing, Chongqing Municipality, China

Location

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

Location

Guangdong Provincial Hospital of Chinese Medicine

Guangzhou, Guangdong, China

Location

Cancer Hospital affiliated to Shantou University Medical College

Shantou, Guangdong, China

Location

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

Location

Harbin Medical University Cancer Hospital

Haerbin, Heilongjiang, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, China

Location

Hubei Cancer Hospital

Wuhan, Hubei, China

Location

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Location

Hunan Cancer Hospital

Changsha, Hunan, China

Location

Northern Jiangsu People's Hospital

Yangzhou, Jiangsu, China

Location

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Location

The First Bethune Hospital of Jilin University

Changchun, Jilin, 130021, China

Location

Liaoning Cancer Hospital and Institute

Shenyang, Liaoning, China

Location

The First Hospital of China Medical University

Shenyang, Liaoning, China

Location

The First Affiliated Hospital of Xi 'an Jiaotong University

Xi'an, Shaanxi, China

Location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

Sichuan Cancer Hospital

Chengdu, Sichuan, China

Location

Yunnan Cancer Hospital

Kunming, Yunnan, China

Location

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hanzhou, Zhejiang, China

Location

MeSH Terms

Interventions

toripalimab

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: March 17, 2020
• First Posted: March 26, 2020
• Study Start: May 9, 2020
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: May 22, 2025

Record last verified: 2025-05

Locations

CN (23)