Clinical Trials /

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

NCT03835949

Description:

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.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: 4309ST101
  • NCT ID: NCT03835949

Conditions

  • Solid Tumor
  • Metastatic Cancer

Interventions

DrugSynonymsArms
TJ004309TJ004309 plus Atezolizumab
AtezolizumabTJ004309 plus Atezolizumab

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
TJ004309 plus AtezolizumabExperimentalTJ004309 will be dose escalated in a 3+3 design in combination with atezolizumab.
  • TJ004309
  • Atezolizumab

Eligibility 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Maximum Tolerate Dose of TJ004309 plus Atezolizumab
Time Frame:Approximately 2-8 months
Safety Issue:
Description: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

Measure:Determine Phase 2 dose to TJ004309 as a single agent
Time Frame:Approximately 2-8 months
Safety Issue:
Description:Determine the Phase 2 dose of TJ004309 as a single agent
Measure:Trough TJ004309 concentrations
Time Frame:Approximately 2-8 months
Safety Issue:
Description:Trough (pre-dose and post-dose) serum TJ004309 concentrations will be measured when given as a single agent and with atezolizumab
Measure:Trough atezolizumab concentrations
Time Frame:Approximately 2-8 months
Safety Issue:
Description:Trough (pre-dose and post-dose) serum atezolizumab concentrations will be measured when given with TJ004309
Measure:Determine the Rate of TJ004309 Immunogenicity
Time Frame:Approximately 2-8 months
Safety Issue:
Description:The number of patients who develop immunogenicity to TJ004309 (anti-product antibody development) will be determined.
Measure:Determine the Rate of Atezolizumab Immunogenicity
Time Frame:Approximately 2-8 months
Safety Issue:
Description:The number of patients who develop immunogenicity to atezolizumab (anti-product antibody development) will be determined.
Measure:Assessment of antitumor activity
Time Frame:Approximately 2-8 months
Safety Issue:
Description:Antitumor activity will be assessed by the response rate by iRECIST and RECIST 1.1

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Tracon Pharmaceuticals Inc.

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