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ACTIVE NOT RECRUITING
NCT03891953
PHASE1

Study of Safety and Efficacy of DKY709 Alone or in Combination With PDR001 in Patients With Advanced Solid Tumors.

Sponsor: Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

This is a phase I/Ib, open label study. The escalation portion will characterize the safety and tolerability of DKY709 and DKY709 in combination with PDR001 in subjects with NSCLC or melanoma who have received prior anti-PD-1/PD-L1 therapy, or subjects with NPC. After the determination of the MTD/RD for a particular treatment arm, dose expansion will further assess safety, tolerability, PK/PD, and anti-tumor activity of each regimen at the MTD/RD.

Official title: A Phase I/Ib, Open-label, Multi-center, Study of DKY709 as a Single Agent and in Combination With PDR001 in Patients With Advanced Solid Tumors

Key Details

Gender

All

Age Range

18 Years - 100 Years

Study Type

INTERVENTIONAL

Enrollment

98

Start Date

2019-05-07

Completion Date

2026-10-31

Last Updated

2026-01-21

Healthy Volunteers

No

Interventions

DRUG

DKY709

Novel immunomodulatory agent

DRUG

PDR001

PDR001 is a high-affinity, ligand-blocking, humanized IgG4 monoclonal antibody directed against PD-1 that blocks the binding of PD-L1 and PD-L2

Locations (9)

Massachusetts General Hospital

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Sarah Cannon Research Institute

Nashville, Tennessee, United States

Novartis Investigative Site

Dresden, Saxony, Germany

Novartis Investigative Site

Essen, Germany

Novartis Investigative Site

Hong Kong, Hong Kong

Novartis Investigative Site

Chuo Ku, Tokyo, Japan

Novartis Investigative Site

Barcelona, Spain

Novartis Investigative Site

Taipei, Taiwan