drugset / Trial / NCT04205227

ENB003 Plus Pembrolizumab Phase 1b/2a in Solid Tumors

NCT04205227

Phase 1/2 Active not recruiting 137 enrolled ENB Therapeutics, Inc Merck Sharp & Dohme LLC · collab
Non-randomizedSingle-groupOpen-labelTreatment

Summary

First-in Human study evaluating the safety, tolerability and efficacy of ENB003 in combination with Pembrolizumab in solid tumors. The study is separated into two parts. Part A is a 3+3 dose escalation to define the recommended RP2D; this part will include metastatic melanoma, platinum resistant ovarian cancer, and pancreatic cancer patients subjects, but other solid tumors will be allowed. Once the RP2D is selected, the study will be expanded into metastatic melanoma, platinum resistant ovarian cancer, and pancreatic cancer subjects. A small number of sarcoma subjects will be included, as exploratory.

Timeline

Start
2020-02-18
Primary completion
2026-01-01
Completion
2026-03-31

Drugs

EvaluationDrugModalityDoseRoute
Subject ENB003 Unknown 150 ug
Subject ENB003 Unknown 300 ug
Subject ENB003 Unknown 500 ug
Subject ENB003 Unknown 750 ug
Subject ENB003 Unknown 1000 ug
Subject ENB003 Unknown 2000 ug
Subject Pembrolizumab Monoclonal antibody 200 mg