Clinical Trials List
Protocol NumberCDKY709A12101C
NCT Number(ClinicalTrials.gov Identfier)NCT03891953
Completed
2019-10-03 - 2025-05-05
Phase I
Recruiting1
ICD-9199.0
Disseminated malignant neoplasm
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
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Trial Applicant
NOVARTIS (TAIWAN) CO., LTD.
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Sponsor
Novartis Pharmaceuticals
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Trial scale
Multi-Regional Multi-Center
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Update
2026/03/01
Investigators and Locations
Co-Principal Investigator
- 廖斌志 Division of Hematology & Oncology
- 廖唯昱 Division of Hematology & Oncology
- 楊景堯 Division of Hematology & Oncology
- 徐偉勛 Division of Hematology & Oncology
- CHAO-CHI HO CHAO-CHI HO Division of Hematology & Oncology
- 蔡子修 Division of Hematology & Oncology
- YEN-TING LIN Division of Hematology & Oncology
- Jih-Hsiang Lee Division of Hematology & Oncology
- JIN-YUAN SHIH Division of Hematology & Oncology
- Hsiang-Fong Kao Division of Hematology & Oncology
- HUAI-CHENG HUANG Division of Hematology & Oncology
- James Chih-Hsin Yang Division of Hematology & Oncology
- Chong-Jen Yu Division of Hematology & Oncology
- 許嘉林 Division of Hematology & Oncology
- 吳尚俊 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Advanced Solid Tumors
Objectives
Primary Objective:
To characterize the safety, tolerability, and maximum tolerated dose/recommended dose for expansion single agent DKY709 and DKY709 in combination with PDR001
Secondary Objective(s):
To evaluate the preliminary anti-tumor activity of single agent DKY709 and DKY709 in combination with PDR001
To determine the pharmacokinetics of single agent DKY709 and DKY709 in combination with PDR001
To assess the immunogenicity of PDR001 when dosed in combination with DKY709
Test Drug
DKY709
Active Ingredient
DKY709
Dosage Form
Hard capsule
Dosage
2 mg, 10 mg, 40 mg
Endpoints
Primary Outcome Measures :
Safety of DKY709 single agent treatment or DKY709 in combination with PDR001. [ Time Frame: 24 months ]
Incidence and severity of AEs and SAEs
incidence of Dose Limiting Toxicities (DLTs) [ Time Frame: 1 Month ]
The incidence of DLTs during the first cycle of treatment with single agent DKY709 or the combination of DKY709 with PDR001.
Tolerability of DKY709 single agent treatment or DKY709 in combination with PDR001. [ Time Frame: 24 months ]
Incidence and severity of AEs and SAEs
Secondary Outcome Measures :
AUC of DKY709 and PDR001 [ Time Frame: 24 months ]
AUC
Cmax of DKY709 and PDR001 [ Time Frame: 24 months ]
Cmax
Tmax of DKY709 and PDR001 [ Time Frame: 24 months ]
Tmax
Half-life of DKY709 and PDR001 [ Time Frame: 24 months ]
Half-life
Concentration vs time profile of DKY709 and PDR001 [ Time Frame: 24 months ]
Concentration vs. time
Progression Free Survival (PFS) [ Time Frame: 24 months ]
Determine PFS in each part of the study
Best Overall Response (BOR) [ Time Frame: 24 months ]
Determine BOR in each part of the study
Duration of Response (DOR) [ Time Frame: 24 months ]
Determine DOR in each part of the study
Time to Progression (TTP) [ Time Frame: 24 months ]
Determine TTP in each part of the study
Safety of DKY709 single agent treatment or DKY709 in combination with PDR001. [ Time Frame: 24 months ]
Incidence and severity of AEs and SAEs
incidence of Dose Limiting Toxicities (DLTs) [ Time Frame: 1 Month ]
The incidence of DLTs during the first cycle of treatment with single agent DKY709 or the combination of DKY709 with PDR001.
Tolerability of DKY709 single agent treatment or DKY709 in combination with PDR001. [ Time Frame: 24 months ]
Incidence and severity of AEs and SAEs
Secondary Outcome Measures :
AUC of DKY709 and PDR001 [ Time Frame: 24 months ]
AUC
Cmax of DKY709 and PDR001 [ Time Frame: 24 months ]
Cmax
Tmax of DKY709 and PDR001 [ Time Frame: 24 months ]
Tmax
Half-life of DKY709 and PDR001 [ Time Frame: 24 months ]
Half-life
Concentration vs time profile of DKY709 and PDR001 [ Time Frame: 24 months ]
Concentration vs. time
Progression Free Survival (PFS) [ Time Frame: 24 months ]
Determine PFS in each part of the study
Best Overall Response (BOR) [ Time Frame: 24 months ]
Determine BOR in each part of the study
Duration of Response (DOR) [ Time Frame: 24 months ]
Determine DOR in each part of the study
Time to Progression (TTP) [ Time Frame: 24 months ]
Determine TTP in each part of the study
Inclution Criteria
Inclusion Criteria:
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
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, primarily refractory to anti-PD-1/PD-L1 therapy with documented PD-L1 ≥ 1%
Melanoma, primarily refractory to 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 Primarily refractory is defined as duration of therapy with a regimen which includes an anti-PD-1/PD-L1 agent ≤ 6 months prior to disease progression and no objective evidence of significant radiologic response during treatment.
ECOG Performance Status ≤ 2
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.
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
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, primarily refractory to anti-PD-1/PD-L1 therapy with documented PD-L1 ≥ 1%
Melanoma, primarily refractory to 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 Primarily refractory is defined as duration of therapy with a regimen which includes an anti-PD-1/PD-L1 agent ≤ 6 months prior to disease progression and no objective evidence of significant radiologic response during treatment.
ECOG Performance Status ≤ 2
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.
Exclusion Criteria
Exclusion Criteria:
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)
Potassium, magnesium, calcium or phosphate abnormality CTCAE > grade 1
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
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)
Potassium, magnesium, calcium or phosphate abnormality CTCAE > grade 1
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
The Estimated Number of Participants
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Taiwan
16 participants
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Global
380 participants
