a clinical study of tj004309 with atezolizumab (tecentriq®) in patients with ovarian cancer and selected solid tumors

Conditions: Ovarian Cancer; Head and Neck Cancer; Non Small Cell Lung Cancer; Gastrointestinal Cancer; Triple Negative Breast Cancer; Ovarian Carcinoma

Summary: this is a multicenter, open label, phase 2 study of tj004309 in combination with atezolizumab in patients with advanced or metastatic solid tumors.

this is a multicenter, open label, phase 2 study of tj004309 in combination with atezolizumab in patients with advanced or metastatic solid tumors. this clinical study includes two cohorts: cohort 1 will include immuno-oncology (io) treatment naïve ovarian cancer (oc) patients who have progressed on or after platinum therapy; and cohort 2 will include patients with head and neck squamous cell carcinoma (hnscc), non-small cell lung cancer (nsclc), gastrointestinal cancer (gc), triple negative breast cancer (tnbc), or ovarian carcinoma (oc) with pd-l1 expression ≥ 1%. additional cohorts for selected tumor types might be added later.

Eligibility criteria:
inclusion criteria: * cohort 1: patients with histologically confirmed epithelial ovarian cancer, fallopian tube, or primary peritoneal cancer subjects with any high-grade serous component, progressed on or after platinum-containing therapy and not eligible for further platinum containing treatment (platinum-resistant, platinum-refractory disease defined by progression of disease on a platinum-containing regimen or recurrence of disease within 180 days of receiving the last dose of platinum-based treatment). * cohort 2: patients with selected tumor types that have relapsed or progressed after 2 lines of therapy or who are ineligible for other standard of care (soc) therapies: 1. histologically or cytologically confirmed metastatic nsclc 2. histologically or cytologically confirmed recurrent or metastatic hnscc (oral cavity, oropharynx, hypopharynx, or larynx) 3. histologically or cytologically confirmed metastatic or non-resectable advanced metastatic gastric or gastroesophageal adenocarcinoma 4. histologically or cytologically confirmed unresectable, locally advanced or metastatic tnbc (confirmed her2-negative, estrogen receptor-negative and progesterone receptor-negative) 5. histologically confirmed ovarian cancer of all high-grade epithelial types who are io treatment naïve and have progressed after 3 months on or after platinum-containing therapy 6. pd-l1 expression tumor proportion score (tps) ≥ 1% for nsclc and combined proportion score (cps) ≥ 1% for all other tumor types 7. a 28-day washout period after the completion of programmed death-1 (pd-1)/pd-l1 therapy 8. patients should have no more than 5 prior lines of therapies * cohort 2 - (optional for the ovarian cohort) pre-treatment fresh tumor biopsies and paired treatment fresh tumor biopsies will be collected from at least 5 patients. biopsy must be excisional, incisional, or core. exclusion criteria: * has received prior therapy with an anti-pd-1, anti-pd-l1, or anti-pd-l2 agent or with an agent directed to another stimulatory or co-inhibitory t-cell receptor (e.g. cytotoxic t-lymphocyte-associated protein 4 \[ctla-4\], ox 40 \[tumor necrosis factor receptor superfamily, member 4 (tnfrsf4)\], cd137 \[tumor necrosis factor receptor superfamily member 9 (tnfrsf9)\]) (only applies to ovarian cancer patients in cohorts 1 and 2) * disease progression within 6 months of starting anti-pd-1 and anti-pd-l1 inhibitors * known active or chronic hepatitis b or hepatitis c, other hepatitides (non-alcohol steatohepatitis, alcohol or drug-related, autoimmune) serology at screening or cirrhosis * active autoimmune disease requiring systemic treatment within the past 12 months * active interstitial lung disease (ild) or pneumonitis or a history of ild * brain involvement with cancer, spinal cord compression, 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 * known human immunodeficiency virus (hiv) unless cd4+ t cell count \> 350 cells/μl with an undetectable viral load