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

NCT ID: NCT03891953

Last Updated: 2025-11-10

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-07
• Study Completion Date: 2026-03-31

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DKY709

DKY709 monotherapy

Group Type: EXPERIMENTAL

DKY709

Intervention Type: DRUG

Novel immunomodulatory agent

DKY709 + PDR001

Combination therapy with DKY709 and PDR001

Group Type: EXPERIMENTAL

DKY709

Intervention Type: DRUG

Novel immunomodulatory agent

PDR001

Intervention Type: 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

Interventions

DKY709

Novel immunomodulatory agent

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Spartalizumab

Eligibility Criteria

Inclusion Criteria

1. Signed informed consent must be obtained prior to participation in the study.

2. Patients must be ≥18 years of age at the time of informed consent form (ICF) signature.

3. 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

4. In expansion: patient with measurable disease as determined by RECIST version 1.1,

5. 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

6. ECOG Performance Status ≤ 1

7. Patients must have a site of disease amenable to core needle biopsy, and be a candidate for tumor biopsy according to the treating institution's guidelines. Patients must be willing to undergo a new tumor biopsy at baseline, and during therapy on the study. Exceptions may be considered after documented discussion with Novartis.

Exclusion Criteria

1. 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.

2. History of severe hypersensitivity reactions to any ingredient of study drug(s) or other mAbs and/or their excipients.

3. 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

4. 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)
• QTc not assessable
• Congenital long QT syndrome
• History of familial long QT syndrome or known family history of as Torsades de Pointes
• Acute myocardial infarction or unstable angina pectoris < 3 months prior to study entry

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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, Catalonia, Spain

Novartis Investigative Site

Taipei, , Taiwan

Countries

United States; Germany; Hong Kong; Japan; Spain; Taiwan

Other Identifiers

2018-002580-26

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CDKY709A12101C

Identifier Type: -

Identifier Source: org_study_id