drugset
drugset / Trial / NCT03983954

Naptumomab Estafenatox in Combination With Durvalumab in Subjects With Selected Advanced or Metastatic Solid Tumor, Including a Cohort Expansion in Esophageal Cancer.

NCT03983954 ↗

Phase 1 Active not recruiting 120 enrolled NeoTX Therapeutics Ltd. AstraZeneca · collab
Non-randomizedSequentialOpen-labelTreatment

Summary

This Phase 1b is a dose escalation, MTD expansion and cohort expansions study to assess the safety and tolerability of a combination of NAP with durvalumab in subjects with selected advanced or metastatic solid tumors.

Timeline

Start
2019-10-10
Primary completion
2027-03-01
Completion
2027-03-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Durvalumab Monoclonal antibody 1500 mg Intravenous
Subject Naptumomab estafenatox Protein / enzyme biologic 2 ug/kg Intravenous
Subject Naptumomab estafenatox Protein / enzyme biologic 5 ug/kg Intravenous
Subject Naptumomab estafenatox Protein / enzyme biologic 10 ug/kg Intravenous
Subject Naptumomab estafenatox Protein / enzyme biologic 15 ug/kg Intravenous
Subject Naptumomab estafenatox Protein / enzyme biologic 20 ug/kg Intravenous
Background Obinutuzumab Monoclonal antibody 1000 mg Intravenous

Indications

cervical squamous cell carcinoma colorectal cancer endometrial cancer esophageal cancer estrogen-receptor positive breast cancer gastroesophageal cancer head and neck squamous cell carcinoma hepatocellular carcinoma melanoma mesothelioma non-small cell lung carcinoma ovarian cancer pancreatic adenocarcinoma prostate cancer renal cell carcinoma triple-negative breast carcinoma urinary bladder cancer urothelial carcinoma