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.
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
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
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
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
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