NCT03891953

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

Active, enrolled Phase 1 Last updated 21 January 2026

What this trial tests

Phase 1 trial testing DKY709 in Carcinoma, Non-Small-Cell Lung in 98 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

7 May 2019

Primary endpoint
30 October 2026

31 October 2026

Quick facts

Lead sponsor	Novartis Pharmaceuticals
Phase	Phase 1
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	98
Start date	7 May 2019
Primary completion	30 October 2026
Estimated completion	31 October 2026
Sites	9 locations across Hong Kong, Japan, Taiwan, Germany, United States, Spain

Drugs / interventions tested

• DKY709 — full drug profile →
• PDR001 — full drug profile →

Conditions studied

• Carcinoma, Non-Small-Cell Lung — all drugs for Carcinoma, Non-Small-Cell Lung →
• Melanoma — all drugs for Melanoma →
• Nasopharyngeal Carcinoma — all drugs for Nasopharyngeal Carcinoma →
• Microsatellite Stable Colorectal Cancer — all drugs for Microsatellite Stable Colorectal Cancer →

Sponsor

Novartis Pharmaceuticals — full company profile →

Who can join

Adults 18 to 100, any sex, with Carcinoma, Non-Small-Cell Lung or Melanoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. PROTAC targeted protein degraders: the past is prologue.
   Békés M, Langley DR, Crews CM. · · 2022 · cited 2098× · PMID 35042991 · DOI 10.1038/s41573-021-00371-6
2. Protein degraders enter the clinic - a new approach to cancer therapy.
   Chirnomas D, Hornberger KR, Crews CM. · · 2023 · cited 430× · PMID 36781982 · DOI 10.1038/s41571-023-00736-3
3. Improvement of the anticancer efficacy of PD-1/PD-L1 blockade via combination therapy and PD-L1 regulation.
   Wu M, Huang Q, Xie Y, Wu X, et al · · 2022 · cited 336× · PMID 35279217 · DOI 10.1186/s13045-022-01242-2
4. Current Advances in the Treatment of BRAF-Mutant Melanoma.
   Patel H, Yacoub N, Mishra R, White A, et al · · 2020 · cited 133× · PMID 32092958 · DOI 10.3390/cancers12020482
5. Skin cancer: understanding the journey of transformation from conventional to advanced treatment approaches.
   Hasan N, Nadaf A, Imran M, Jiba U, et al · · 2023 · cited 117× · PMID 37803407 · DOI 10.1186/s12943-023-01854-3
6. Targeted protein degradation: advances in drug discovery and clinical practice.
   Zhong G, Chang X, Xie W, Zhou X. · · 2024 · cited 112× · PMID 39500878 · DOI 10.1038/s41392-024-02004-x
7. Clinical considerations for the design of PROTACs in cancer.
   Nieto-Jiménez C, Morafraile EC, Alonso-Moreno C, Ocaña A. · · 2022 · cited 71× · PMID 35249548 · DOI 10.1186/s12943-022-01535-7
8. Revolutionization in Cancer Therapeutics via Targeting Major Immune Checkpoints PD-1, PD-L1 and CTLA-4.
   Pandey P, Khan F, Qari HA, Upadhyay TK, et al · · 2022 · cited 67× · PMID 35337133 · DOI 10.3390/ph15030335