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Trial record 1 of 1 for:    NCT03835949
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Study of TJ004309 in Combination With Atezolizumab (Tecentriq®) in Patients With Advanced or Metastatic Cancer

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ClinicalTrials.gov Identifier: NCT03835949
Recruitment Status : Recruiting
First Posted : February 11, 2019
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
Tracon Pharmaceuticals Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Solid Tumor Metastatic Cancer Drug: TJ004309 Drug: Atezolizumab Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Dose-Escalation Study of TJ004309 in Combination With Atezolizumab (Tecentriq®) in Patients With Advanced or Metastatic Cancer
Estimated Study Start Date : April 12, 2019
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: TJ004309 plus Atezolizumab
TJ004309 will be dose escalated in a 3+3 design in combination with atezolizumab.
Drug: TJ004309
Antibody to CD73

Drug: Atezolizumab
Humanized monoclonal antibody to PD-L1




Primary Outcome Measures :
  1. Maximum Tolerate Dose of TJ004309 plus Atezolizumab [ Time Frame: Approximately 2-8 months ]
    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.


Secondary Outcome Measures :
  1. Determine Phase 2 dose to TJ004309 as a single agent [ Time Frame: Approximately 2-8 months ]
    Determine the Phase 2 dose of TJ004309 as a single agent

  2. Trough TJ004309 concentrations [ Time Frame: Approximately 2-8 months ]
    Trough (pre-dose and post-dose) serum TJ004309 concentrations will be measured when given as a single agent and with atezolizumab

  3. Trough atezolizumab concentrations [ Time Frame: Approximately 2-8 months ]
    Trough (pre-dose and post-dose) serum atezolizumab concentrations will be measured when given with TJ004309

  4. Determine the Rate of TJ004309 Immunogenicity [ Time Frame: Approximately 2-8 months ]
    The number of patients who develop immunogenicity to TJ004309 (anti-product antibody development) will be determined.

  5. Determine the Rate of Atezolizumab Immunogenicity [ Time Frame: Approximately 2-8 months ]
    The number of patients who develop immunogenicity to atezolizumab (anti-product antibody development) will be determined.

  6. Assessment of antitumor activity [ Time Frame: Approximately 2-8 months ]
    Antitumor activity will be assessed by the response rate by iRECIST and RECIST 1.1



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically confirmed advanced or metastatic cancer in patients who are refractory to or intolerant to all available therapy.
  2. Measurable disease by iRECIST
  3. 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.
  4. Age ≥ 18 years
  5. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
  6. 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)
  7. Adequate organ function
  8. Willingness and ability to consent for self to participate in study
  9. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures

Exclusion Criteria:

  1. Autoimmune disease requiring treatment within the past twelve months
  2. Condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days prior to study treatment
  3. History of or active interstitial lung disease
  4. Prior T-cell therapy
  5. Current treatment on another therapeutic clinical trial
  6. Receipt of systemic anticancer therapy, including investigational agents, within 28 days prior to study treatment
  7. 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
  8. 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.
  9. Hypertension defined as blood pressure (BP) systolic > 150 or diastolic > 90 mm Hg
  10. Ascites or pericardial effusion that required intervention within 3 months prior to study treatment.
  11. 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
  12. 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
  13. Thrombolytic use (except to maintain IV catheters) within 10 days prior study treatment
  14. Known active viral or nonviral hepatitis or cirrhosis, except patients with Hepatitis C infection and undetectable virus following treatment are eligible.
  15. Any active infection requiring systemic treatment
  16. History of hemorrhage or hemoptysis (> ½ teaspoon bright red blood) within 3 months prior to study treatment
  17. Known human immunodeficiency virus (HIV) unless CD4+ T cell count > 350 cells/μL with an undetectable viral load.
  18. 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, 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 6 months following last dose of TJ004309.
  19. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03835949


Contacts
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Contact: Charles Theuer, MD, PhD (858) 251-3490 clinicaltrials@traconpharma.com

Locations
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United States, Alabama
The University of Alabama at Birmingham Not yet recruiting
Birmingham, Alabama, United States, 35294
United States, Arizona
HonorHealth Research Institute Not yet recruiting
Scottsdale, Arizona, United States, 85258
United States, California
City of Hope Recruiting
Duarte, California, United States, 91010
United States, Texas
MD Anderson Cancer Center Not yet recruiting
Houston, Texas, United States, 77230
Sponsors and Collaborators
Tracon Pharmaceuticals Inc.
Investigators
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Study Director: Charles Theuer, MD, PhD Medical Monitor

Additional Information:
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Responsible Party: Tracon Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT03835949     History of Changes
Other Study ID Numbers: 4309ST101
First Posted: February 11, 2019    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplasms, Second Primary
Neoplasms
Neoplastic Processes
Pathologic Processes
Atezolizumab
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs