Clinical Trials Directory

Trials / Active Not Recruiting

Active Not RecruitingNCT03891953

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

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

Status
Active Not Recruiting
Phase
Phase 1
Study type
Interventional
Enrollment
98 (actual)
Sponsor
Novartis Pharmaceuticals · Industry
Sex
All
Age
18 Years – 100 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGDKY709Novel immunomodulatory agent
DRUGPDR001PDR001 is a high-affinity, ligand-blocking, humanized IgG4 monoclonal antibody directed against PD-1 that blocks the binding of PD-L1 and PD-L2

Timeline

Start date
2019-05-07
Primary completion
2026-10-30
Completion
2026-10-31
First posted
2019-03-27
Last updated
2026-01-21

Locations

9 sites across 6 countries: United States, Germany, Hong Kong, Japan, Spain, Taiwan

Regulatory

Source: ClinicalTrials.gov record NCT03891953. Inclusion in this directory is not an endorsement.