AzTrials
AzTrials

Advanced Solid TumorPhase 1/2NCT04322006

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

A Phase 1/2 study testing TJ004309 and Toripalimab in people with Advanced Solid Tumor, run by TJ Biopharma Co., Ltd. at 23 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumor
What is being tested?
TJ004309 and Toripalimab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
225 participants
Where
23 sitesChina
Study dates
9 May 2020to 30 Apr 2025
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 17Show fewer
  • 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
  • The man have reproductive ability or childbearing female (refers to men and women not on birth control operation, and the menopause women), must use the highly effective contraceptive methods (such as oral contraceptives, intrauterine contraceptive device, abstemious sexual desire or barrier contraceptive method combined with spermicide) during the study, and sustain contraception 6 months after the last dose
  • Willingness and ability to consent for self to participate in study and comply with scheduled visits, treatment plan, laboratory tests, and other study procedures

Who cannot join

  • 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.)
Show all 20Show fewer
  • 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.)
  • Cardiovascular diseases with clinical significance, include phase II-III cardiac insufficiency defined by New York Heart Association, myocardial infarction (MI) within 3 months prior to study treatment, symptomatic congestive heart failure, cerebral infarction within 3 months prior to study treatment, percutaneous transluminal coronary angioplasty (PTCA), or coronary artery bypass grafting (CABG) within 6 months prior to study treatment
  • Deep-venous thrombosis within 6 months prior to study treatment (except treated without warfarin 2 weeks prior to study treatment)
  • Thrombolytic use (except to maintain IV catheters) within 10 days prior study treatment
  • Any active infection requiring systemic treatment
  • Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for this study

Trial locations and contacts

23 sites in 1 country.

23 sites in 1 country

China23 sites

  • Cancer Hospital, Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality

  • The First Bethune Hospital of Jilin University

    Changchun, Jilin, 130021

  • Hunan Cancer Hospital

    Changsha, Hunan

  • Sichuan Cancer Hospital

    Chengdu, Sichuan

  • Army Medical Center of PLA

    Chongqing, Chongqing Municipality

  • Chongqing Cancer Hospital

    Chongqing, Chongqing Municipality

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong, 510080

  • Guangdong Provincial Hospital of Chinese Medicine

    Guangzhou, Guangdong

  • Harbin Medical University Cancer Hospital

    Haerbin, Heilongjiang

  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

    Hanzhou, Zhejiang

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui

  • Yunnan Cancer Hospital

    Kunming, Yunnan

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

  • Cancer Hospital affiliated to Shantou University Medical College

    Shantou, Guangdong

  • Liaoning Cancer Hospital and Institute

    Shenyang, Liaoning

  • The First Hospital of China Medical University

    Shenyang, Liaoning

  • Hubei Cancer Hospital

    Wuhan, Hubei

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

    Wuhan, Hubei

  • The First Affiliated Hospital of Xi 'an Jiaotong University

    Xi'an, Shaanxi

  • Northern Jiangsu People's Hospital

    Yangzhou, Jiangsu

  • Henan Cancer Hospital

    Zhengzhou, Henan

Other trials in China

About this study

Official title: 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

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.

Being tested
TJ004309, Toripalimab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TJ004309Drug

    Antibody to CD73

  • ToripalimabDrug

    Humanized monoclonal antibody to PD-1

Study groups in NCT04322006
Study groupRoleWhat they receive
TJ004309 injection Monotherapy or Combination with ToripalimabExperimentalTJ004309 will be dose escalated in a 3+3 design in Monotherapy or combination with Toripalimab
Receives: Drug: TJ004309; Drug: Toripalimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose Limiting Toxicities(DLT)

    The safety and tolerance of TJ004309

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

  2. MTD

    Maximum tolerated dose (MTD)

    Measured: 2 years

  3. MED

    Maximum effective dose (MED)

    Measured: 2 years

  4. Recommend dose of TJ004309

    Recommend dose of TJ004309

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Mar 2020
  2. Study start9 May 2020
  3. Primary completion30 Apr 2025
  4. Study completion30 Apr 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
225 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04322006
Sponsor's protocol ID
TJ004309STM102
Status last verified
May 2026
First submitted
17 Mar 2020
Last updated
13 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing TJ004309 and Toripalimab in people with Advanced Solid Tumor, run by TJ Biopharma Co., Ltd. at 23 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose Limiting Toxicities(DLT) (time frame: 28days after first dose for QW, 21days after first dose for Q3W). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04322006.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in