Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03835949
Recruitment Status : Recruiting
First Posted : February 11, 2019
Last Update Posted : February 3, 2021
Sponsor:
Information provided by (Responsible Party):
Tracon Pharmaceuticals Inc.

Tracking Information
First Submitted Date  ICMJE February 5, 2019
First Posted Date  ICMJE February 11, 2019
Last Update Posted Date February 3, 2021
Actual Study Start Date  ICMJE July 26, 2019
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 7, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 7, 2019)
  • 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
  • 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
  • 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
  • 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.
  • 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.
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of TJ004309 in Combination With Atezolizumab (Tecentriq®) in Patients With Advanced or Metastatic Cancer
Official Title  ICMJE A Phase 1 Dose-Escalation Study of TJ004309 in Combination With Atezolizumab (Tecentriq®) in Patients With Advanced or Metastatic Cancer
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Solid Tumor
  • Metastatic Cancer
Intervention  ICMJE
  • Drug: TJ004309
    Antibody to CD73
  • Drug: Atezolizumab
    Humanized monoclonal antibody to PD-L1
Study Arms  ICMJE Experimental: TJ004309 plus Atezolizumab
TJ004309 will be dose escalated in a 3+3 design in combination with atezolizumab.
Interventions:
  • Drug: TJ004309
  • Drug: Atezolizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 7, 2019)
36
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2021
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 or NK 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 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.
  19. 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.
  20. 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Charles Theuer, MD, PhD (858) 251-3490 clinicaltrials@traconpharma.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03835949
Other Study ID Numbers  ICMJE 4309ST101
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Tracon Pharmaceuticals Inc.
Study Sponsor  ICMJE Tracon Pharmaceuticals Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Charles Theuer, MD, PhD Medical Monitor
PRS Account Tracon Pharmaceuticals Inc.
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP