Completed • Phasen II • Stufe III, IV • ER negativ • PR negativ • HER2 negativ • Post-Menopausal • Interventionell

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A Clinical Study of TJ004309 With Atezolizumab (TECENTRIQ®) in Patients With Ovarian Cancer and Selected Solid Tumors

Brief Summary

This is a multicenter, open label, Phase 2 study of TJ004309 in combination with atezolizumab in patients with advanced or metastatic solid tumors.

Beschreibung

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.

Studiendesign

Zulassungskriterien

Arms and Intervention

• TJ004309

Einschlusskriterien

• 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:

• histologically or cytologically confirmed metastatic nsclc

• histologically or cytologically confirmed recurrent or metastatic hnscc (oral cavity, oropharynx, hypopharynx, or larynx)

• histologically or cytologically confirmed metastatic or non-resectable advanced metastatic gastric or gastroesophageal adenocarcinoma

• histologically or cytologically confirmed unresectable, locally advanced or metastatic tnbc (confirmed her2-negative, estrogen receptor-negative and progesterone receptor-negative)

• 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

• pd-l1 expression tumor proportion score (tps) ≥ 1% for nsclc and combined proportion score (cps) ≥ 1% for all other tumor types

• a 28-day washout period after the completion of programmed death-1 (pd-1)/pd-l1 therapy

• 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.

Ausschlusskriterien

• 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