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

NCT03891953 | Active Not Recruiting Phase 1 FDA Drug

• 2 other identifiers: CDKY709A12101C2018-002580-26
• Study Type: interventional
• Target: 98
• Locations: 6 countries
• Sites: 9

Brief 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

Carcinoma, Non-Small-Cell Lung; Melanoma; Nasopharyngeal Carcinoma; Microsatellite Stable Colorectal Cancer; Triple Negative Breast Cancer

Keywords

Non-small Cell Lung Cancer; Melanoma; Nasopharyngeal Carcinoma; Microsatellite Stable Colorectal Cancer; Triple Negative Breast Cancer

Outcome Measures

Primary Outcomes (3)

• Safety of DKY709 single agent treatment or DKY709 in combination with PDR001.

  Incidence and severity of AEs and SAEs

  24 months

• incidence of Dose Limiting Toxicities (DLTs)

  The incidence of DLTs during the first cycle of treatment with single agent DKY709 or the combination of DKY709 with PDR001.

  1 Month

• Tolerability of DKY709 single agent treatment or DKY709 in combination with PDR001.

  Incidence and severity of AEs and SAEs

  24 months

Secondary Outcomes (8)

• AUC of DKY709 and PDR001

  24 months

• Cmax of DKY709 and PDR001

  24 months

• Tmax of DKY709 and PDR001

  24 months

• Half-life of DKY709 and PDR001

  24 months

• Progression Free Survival (PFS)

  24 months

Study Arms (2)

DKY709

EXPERIMENTAL

DKY709 monotherapy

Drug: DKY709

DKY709 + PDR001

EXPERIMENTAL

Combination therapy with DKY709 and PDR001

Drug: DKY709; Drug: PDR001

Interventions

DKY709 DRUG

Novel immunomodulatory agent

DKY709; DKY709 + PDR001

PDR001 DRUG

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

Also known as: Spartalizumab

DKY709 + PDR001

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent must be obtained prior to participation in the study.
• Patients must be ≥18 years of age at the time of informed consent form (ICF) signature.
• Patients with advanced/metastatic cancer who have progressed despite having received standard therapy in the metastatic setting or are intolerant to standard therapy, and for whom no effective standard therapy is available
• In expansion: patient with measurable disease as determined by RECIST version 1.1,
• Dose escalation, patients must fit into one of the following groups:
• NSCLC, previously treated with an anti-PD-1/PD-L1 therapy
• Cutaneous Melanoma, previously treated with an anti-PD-1/PD-L1 therapy
• NPC
• Dose expansion part, patients must fit into one of the following groups:
• NSCLC with historic documentation of PD-L1 ≥ 1%. Patients must have progressive disease after having experienced at least 4 months of investigator-assessed disease stability or response on prior anti-PD-L1-containing therapy
• Cutaneous Melanoma, previously treated with anit-PD-1/PD-L1 therapy. Patients should have documented progression following anti-PD-1/PD-L1 therapy.
• NPC, naive to anti-PD-1/PD-L1 therapy
• mssCRC, naive to anti-PD-1/PD-L1 therapy
• TNBC, naive to anti-PD-1/PD-L1 therapy
• ECOG Performance Status ≤ 1

You may not qualify if:

• Presence of symptomatic central nervous system (CNS) metastases, or CNS metastases that require local CNS-directed therapy (such as radiotherapy or surgery), or increasing doses of corticosteroids within 2 weeks prior to study entry. Patients with treated brain metastases should be neurologically stable for at least 4 weeks prior to study entry and off steroids for at least 2 weeks before administration of any study treatment.
• History of severe hypersensitivity reactions to any ingredient of study drug(s) or other mAbs and/or their excipients.
• Patient with out of range laboratory values defined as:
• Creatinine clearance (calculated using Cockcroft-Gault formula, or measured) \< 40 mL/min
• Total bilirubin \> 1.5 x ULN, except for patients with Gilbert's syndrome who are excluded if total bilirubin \> 3.0 x ULN or direct bilirubin \> 1.5 x ULN
• Alanine aminotransferase (ALT) \> 3 x ULN, except for patients that have tumor involvement of the liver, who are excluded if ALT \> 5 x ULN
• Aspartate aminotransferase (AST) \> 3 x ULN, except for patients that have tumor involvement of the liver, who are excluded if AST \> 5 x ULN
• Absolute neutrophil count (ANC) \< 1.0 x 109/L
• Platelet count \< 75 x 109/L (growth factor or transfusion support may not be used to meet entry criterion)
• Hemoglobin (Hgb) \< 8 g/dL (growth factor or transfusion support may not be used to meet entry criterion)
• Magnesium, calcium or phosphate abnormality CTCAE \> grade 1
• Potassium abnormality CTCAE ≥ grade 1; supplementation to meet eligibility criteria is acceptable
• Clinically significant cardiac disease or impaired cardiac function, including any of the following:
• Clinically significant and/or uncontrolled heart disease such as congestive heart failure requiring treatment (NYHA grade ≥ 2), uncontrolled hypertension or clinically significant arrhythmia
• On screening: QTcF \> 450 msec (male), or \> 460 msec (female)

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (9)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

Novartis Investigative Site

Dresden, Saxony, 01307, Germany

Location

Novartis Investigative Site

Essen, 45147, Germany

Location

Novartis Investigative Site

Hong Kong, 999077, Hong Kong

Location

Novartis Investigative Site

Chuo Ku, Tokyo, 1040045, Japan

Location

Novartis Investigative Site

Barcelona, 08035, Spain

Location

Novartis Investigative Site

Taipei, 10002, Taiwan

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Melanoma; Nasopharyngeal Carcinoma; Triple Negative Breast Neoplasms

Interventions

spartalizumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Breast Neoplasms; Breast Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2019
• First Posted: March 27, 2019
• Study Start: May 7, 2019
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1); DE (2); TW (1); US (3); HK (1); JP (1)