A PHASE 1/2 OPEN-LABEL DOSE-ESCALATION SAFETY AND TOLERABILITY STUDY OF NC410 IN SUBJECTS WITH ADVANCED OR METASTATIC SOLID TUMORS
Are you eligible to participate in this study?
You may be eligible for this study if you meet the following criteria:
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Conditions: Advanced Or Metastatic Solid Tumors
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Age: Between 18 years - 100 years
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Gender: Male or Female
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Other Inclusion Criteria:
1) ECOG performance status 0 to 1. 2) Locally advanced or metastatic disease; locally advanced disease must not be amenable to resection with curative intent. a. Phase 1: Subjects with advanced or metastatic head and neck squamous cell carcinoma, non-small cell lung cancer, ovarian cancer, cervical cancer, endometrial cancer, gastric cancer (including stomach, esophageal, and gastroesophageal junction), hepatocellular carcinoma (HCC), melanoma, pancreatic cancer, Merkel cell carcinoma, colorectal cancer (CRC), metastatic castrate resistant prostate cancer (CRPC), renal cell carcinoma (RCC), triple negative breast cancer (TNBC), and urothelial carcinoma. b. Phase 2: Subjects with ovarian, gastric and colorectal cancer. 3) Subjects who have disease progression after treatment with available therapies that are known to confer clinical benefit, or who are intolerant to treatment, or who refuse standard treatment.
You may not be eligible for this study if the following are true:
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1) Has not recovered to = Grade 1 from toxic effects of prior therapy (including prior immunotherapy and radiation therapy) and/or complications from prior surgical intervention before starting therapy. 2) Receipt of a live vaccine within 30 days of planned start of study therapy. 3) Documented known activating or driver mutations (i.e. EGFR mutations/amplification, BRAF mutations, ALK alterations, etc.) which have not been previously treated with a standard of care targeted therapy.
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