drugset / Trial / NCT04895748

DFF332 as a Single Agent and in Combination With Everolimus & Immuno-Oncology Agents in Advanced/Relapsed Renal Cancer & Other Malignancies

NCT04895748 ↗

Phase 1 Terminated 40 enrolled Novartis Pharmaceuticals
Non-randomizedSequentialOpen-labelTreatment

Summary

This was a first in human study of DFF332, a small molecule that targets a protein called HIF2α. By acting on HIF2α, DFF332 may be able to stop the growth of certain types of cancer. DFF332 was planned to be tested at different doses as single agent and in combination with Everolimus (RAD001, an mTOR inhibitor), and also in combination with Spartalizumab (PDR001, an anti-PD1) plus Taminadenant (NIR178, an adenosine A2A receptor antagonist), in patients with advanced clear cell renal cell carcinoma and other malignancies with HIF stabilizing mutations.

Timeline

Start
2021-11-30
Primary completion
2026-02-13
Completion
2026-02-13

Outcome

Outcome not reported

Stopped (Business): “Business decision and not related to safety concerns”

Drugs

EvaluationDrugModalityDoseRoute
Subject DFF332 Small molecule — —
Subject Everolimus Small molecule — —
Subject NIR178 Unknown — —
Subject Spartalizumab Monoclonal antibody — —