drugset / Trial / NCT05081609

A Study to Investigate Safety and Tolerability of TransCon IL-2 β/γ Alone or in Combination With Pembrolizumab and/or TransCon TLR7/8 Agonist or Other Anticancer Therapies in Adult Participants With Locally Advanced or Metastatic Solid Tumor Malignancies

NCT05081609

Phase 1/2 Active not recruiting 320 enrolled Ascendis Pharma A/S
Non-randomizedSequentialOpen-labelTreatment

Summary

TransCon IL-2 β/γ is an investigational drug being developed for treatment of locally advanced or metastatic solid tumors. This is a first-in-human, open-label, Phase 1/2, dose escalation and dose expansion study of TransCon IL-2 β/γ as monotherapy or in combination therapy in adult participants with advanced or metastatic solid tumors. Given the unique PK profile enabled by the TransCon technology, TransCon IL-2 β/γ presents the opportunity to enhance the therapeutic index of current IL-2 therapy.

Timeline

Start
2022-01-11
Primary completion
2027-08
Completion
2029-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Pembrolizumab Monoclonal antibody Intravenous
Subject TransCon IL-2 β/γ Protein / enzyme biologic Intravenous
Subject Trastuzumab Monoclonal antibody Intravenous
Subject Trastuzumab emtansine Other / unclassified Intravenous