A Phase 1 Dose Escalation and Cohort Expansion Study of TSR-042, an Anti-PD-1 Monoclonal Antibody, in Patients With Advanced Solid Tumors
This is a multicenter, open-label, first-in-human Phase 1 study evaluating the anti-programmed death receptor 1 (anti-PD-1) antibody TSR-042 in patients with advanced solid tumors who have limited available treatment options. The study will be conducted in 2 parts: dose escalation and cohort expansion. The cohort expansion may include up to 5 tumor types, including endometrial and Non-Small Cell Lung cancer.
Cancer (Oncology) - All Solid Tumors,
Cancer (Oncology) - Cholangiocarcinoma,
Cancer (Oncology) - Bladder,
Cancer (Oncology) - Breast,
Cancer (Oncology) - Colon,
Cancer (Oncology) - Colorectal,
Cancer (Oncology) - Endometrial,
Cancer (Oncology) - Esophageal,
Cancer (Oncology) - Gastroesophageal Junction,
Cancer (Oncology) - Gynecology,
Cancer (Oncology) - Kidney,
Cancer (Oncology) - Liver,
Cancer (Oncology) - Lung,
Cancer (Oncology) - Pancreas,
Cancer (Oncology) - Peritoneal,
Cancer (Oncology) - Prostate,
Cancer (Oncology) - Rectal,
Cancer (Oncology) - Renal,
Cancer (Oncology) - Stomach
Joshua Press, MD
Swedish Cancer Institute
|Ages Eligible for Study:
||18 Years and older (Adult, Senior)
|Sexes Eligible for Study:
|Accepts Healthy Volunteers:
- Patient has received prior therapy with an anti- programmed death receptor 1 (anti-PD-1), anti-PD-1- ligand-1 (anti-PD-L1), or anti-PD-1 ligand-2 (anti-PD- L2) agent.
- Known uncontrolled central nervous system (CNS) metastases and/or carcinomatous meningitis. Note: Patients with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least 4 weeks prior to the first dose of study treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are clinically stable off steroids for at least 7 days prior to study treatment. Carcinomatous meningitis precludes a patient from study participation regardless of clinical stability.
- Known additional malignancy that progressed or required active treatment within the last 2 years. Exceptions include basal cell carcinoma of the skin, squamous cell cancer (SqCC) of the skin that has undergone potentially curative therapy, or in situ cervical cancer.
- Known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies).
- Known active hepatitis B (eg, hepatitis B surface antigen [HBsAg] reactive) or hepatitis C (eg, hepatitis C virus ribonucleic acid (HCV RNA) (qualitative) is detected).
- Active autoimmune disease that has required systemic treatment in the past 2 years (ie, with use of disease- modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- History of interstitial lung disease.