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Solid TumorPhase 1NCT03835949

Study of TJ004309 in Combination With Atezolizumab (Tecentriq®) in Patients With Advanced or Metastatic Cancer

A Phase 1 study testing TJ004309 and Atezolizumab in people with Solid Tumor and Metastatic Cancer, run by Tracon Pharmaceuticals Inc. at 4 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a multicenter, open label, Phase 1 dose escalation study of TJ004309 in combination with standard dose atezolizumab in patients with advanced or metastatic cancer in patients who are refractory to or intolerant to all available therapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumor, Metastatic Cancer
What is being tested?
TJ004309 and Atezolizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
4 sitesUnited States
Study dates
16 Jul 2019to Jun 2022
Phase
Phase 1
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

  • Histologically confirmed advanced or metastatic cancer in patients who are refractory to or intolerant to all available therapy.
  • Measurable disease by iRECIST
  • Formalin fixed, paraffin-embedded (FFPE) tumor tissue that permits the preparation of 12 unstained slides of tumor sample- Biopsy must be excisional, incisional, or core. Needle aspiration is insufficient.
  • Age ≥ 18 years
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
  • Resolution of all acute adverse events resulting from prior cancer therapies to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤ 1 or baseline (except alopecia or neuropathy)
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  • Adequate organ function
  • Willingness and ability to consent for self to participate in study
  • Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures

Who cannot join

  • Autoimmune disease requiring treatment within the past twelve months
  • Condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days prior to study treatment
  • History of or active interstitial lung disease
  • Prior T-cell or NK cell therapy
  • Current treatment on another therapeutic clinical trial
  • Receipt of systemic anticancer therapy, including investigational agents, within 28 days prior to study treatment
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  • Major surgical procedure or significant traumatic injury within 4 weeks prior to study treatment, and must have fully recovered from any such procedure; and no date of surgery (if applicable) or anticipated need for a major surgical procedure planned within the next 6 months
  • Chest radiotherapy ≤ 28 days, wide field radiotherapy ≤ 28 days (defined as > 50% of volume of pelvic bones or equivalent), or limited field radiation for palliation ≤ 14 days prior to study treatment - such patients must have recovered adequately from any side effects of such therapy.
  • Hypertension defined as blood pressure (BP) systolic > 150 or diastolic > 90 mm Hg
  • Ascites or pericardial effusion that required intervention within 3 months 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 CNS disease over the 7 days prior to study treatment
  • Angina, myocardial infarction (MI), symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack TIA), arterial embolism, pulmonary embolism, percutaneous transluminal coronary angioplasty (PTCA), or coronary artery bypass grafting (CABG) within 6 months prior to study treatment
  • Thrombolytic use (except to maintain IV catheters) within 10 days prior study treatment
  • Known active viral or nonviral hepatitis or cirrhosis, except patients with Hepatitis C infection and undetectable virus following treatment are eligible.
  • Any active infection requiring systemic treatment
  • History of hemorrhage or hemoptysis (> ½ teaspoon bright red blood) within 3 months prior to study treatment
  • Known human immunodeficiency virus (HIV) unless CD4+ T cell count > 350 cells/μL with an undetectable viral load.
  • Pregnancy or breastfeeding - Female patients must be surgically sterile (i.e., ≥ 6 weeks following surgical bilateral oophorectomy with or without hysterectomy or tubal ligation) or be postmenopausal for at least one year, or must agree to use effective contraception during the study and for 5 months following last dose of TJ004309. All female patients of reproductive potential must have a negative pregnancy test (serum or urine) within 7 days prior to study treatment. Male patients must be surgically sterile or must agree to use effective contraception during the study and for 5 months following last dose of TJ004309.
  • Patients with any severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infections should not be enrolled in the trial. Patients who required IV antibiotics or were treated with antiviral medications within this 4 week period should be discussed with the TRACON prior to enrollment.
  • 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

4 sites in 1 country.

United States4 sites

  • The University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • City of Hope

    Duarte, California, 91010

  • MD Anderson Cancer Center

    Houston, Texas, 77230

  • HonorHealth Research Institute

    Scottsdale, Arizona, 85258

Other trials in United States

About this study

Official title: A Phase 1 Dose-Escalation Study of TJ004309 in Combination With Atezolizumab (Tecentriq®) in Patients With Advanced or Metastatic Cancer

This is a multicenter, open label, Phase 1 dose escalation study of TJ004309 in combination with standard dose atezolizumab in patients with advanced or metastatic cancer in patients who are refractory to or intolerant to all available therapy.

Being tested
TJ004309, Atezolizumab
Medical subject headings
Neoplasm Metastasis

What participants receive

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

  • TJ004309Drug

    Antibody to CD73

  • AtezolizumabDrug

    Humanized monoclonal antibody to PD-L1

Study groups in NCT03835949
Study groupRoleWhat they receive
TJ004309 plus AtezolizumabExperimentalTJ004309 will be dose escalated in a 3+3 design in combination with atezolizumab.
Receives: Drug: TJ004309; Drug: Atezolizumab

What is being measured

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

  1. Maximum Tolerate Dose of TJ004309 plus Atezolizumab

    Evaluate safety and tolerability and determine a recommended Phase 2 dose of TJ004309 when combined with standard dose atezolizumab in patients with advanced or metastatic cancer. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 and coded using MedDRA 14.1.

    Measured: Approximately 2-8 months

Secondary outcomes (6)

  1. Determine Phase 2 dose to TJ004309 as a single agent

    Determine the Phase 2 dose of TJ004309 as a single agent

    Measured: Approximately 2-8 months

  2. Trough TJ004309 concentrations

    Trough (pre-dose and post-dose) serum TJ004309 concentrations will be measured when given as a single agent and with atezolizumab

    Measured: Approximately 2-8 months

  3. Trough atezolizumab concentrations

    Trough (pre-dose and post-dose) serum atezolizumab concentrations will be measured when given with TJ004309

    Measured: Approximately 2-8 months

  4. Determine the Rate of TJ004309 Immunogenicity

    The number of patients who develop immunogenicity to TJ004309 (anti-product antibody development) will be determined.

    Measured: Approximately 2-8 months

  5. Determine the Rate of Atezolizumab Immunogenicity

    The number of patients who develop immunogenicity to atezolizumab (anti-product antibody development) will be determined.

    Measured: Approximately 2-8 months

  6. Assessment of antitumor activity

    Antitumor activity will be assessed by the response rate by iRECIST and RECIST 1.1

    Measured: Approximately 2-8 months

Timeline

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

  1. First posted11 Feb 2019
  2. Study start16 Jul 2019
  3. Primary completionJun 2022 (estimated)
  4. Study completionJun 2022 (estimated)

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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03835949
Sponsor's protocol ID
4309ST101
Status last verified
Mar 2022
First submitted
5 Feb 2019
Last updated
1 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TJ004309 and Atezolizumab in people with Solid Tumor and Metastatic Cancer, run by Tracon Pharmaceuticals Inc. at 4 sites in United States.

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 9 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: status not confirmed, as of the sponsor's last update on 1 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. 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 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.

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

Are results available for this study?

Results are not available in the source record.

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?

Maximum Tolerate Dose of TJ004309 plus Atezolizumab (time frame: Approximately 2-8 months). 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 NCT03835949.

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 1 Apr 2022.

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