Study of Safety and Efficacy of DKY709 Alone or in Combination With PDR001 in Patients With Advanced Solid Tumors.
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ClinicalTrials.gov Identifier: NCT03891953 |
Recruitment Status :
Active, not recruiting
First Posted : March 27, 2019
Last Update Posted : April 15, 2024
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Condition or disease | Intervention/treatment | Phase |
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Carcinoma, Non-Small-Cell Lung Melanoma Nasopharyngeal Carcinoma Microsatellite Stable Colorectal Cancer Triple Negative Breast Cancer | Drug: DKY709 Drug: PDR001 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 98 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Actual Study Start Date : | May 7, 2019 |
Estimated Primary Completion Date : | September 12, 2024 |
Estimated Study Completion Date : | September 12, 2024 |
Arm | Intervention/treatment |
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Experimental: DKY709
DKY709 monotherapy
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Drug: DKY709
Novel immunomodulatory agent |
Experimental: DKY709 + PDR001
Combination therapy with DKY709 and PDR001
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Drug: DKY709
Novel immunomodulatory agent 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
Other Name: Spartalizumab |
- 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
- 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
- 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
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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,
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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
- 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:
- 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.
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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
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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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03891953
United States, Massachusetts | |
Massachusetts General Hospital Massachusetts Gen Hosp | |
Boston, Massachusetts, United States, 02114 | |
Dana Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 | |
United States, Tennessee | |
Sarah Cannon Research Institute Drug Ship - 3 | |
Nashville, Tennessee, United States, 37203 | |
Germany | |
Novartis Investigative Site | |
Dresden, Germany, 01307 | |
Novartis Investigative Site | |
Essen, Germany, 45147 | |
Hong Kong | |
Novartis Investigative Site | |
Shatin New Territories, Hong Kong | |
Japan | |
Novartis Investigative Site | |
Chuo ku, Tokyo, Japan, 104 0045 | |
Spain | |
Novartis Investigative Site | |
Barcelona, Catalunya, Spain, 08035 | |
Taiwan | |
Novartis Investigative Site | |
Taipei, Taiwan, 10002 |
Responsible Party: | Novartis Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT03891953 |
Other Study ID Numbers: |
CDKY709A12101C 2018-002580-26 ( EudraCT Number ) |
First Posted: | March 27, 2019 Key Record Dates |
Last Update Posted: | April 15, 2024 |
Last Verified: | April 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Non-small Cell Lung Cancer Melanoma Nasopharyngeal Carcinoma Microsatellite Stable Colorectal Cancer Triple Negative Breast Cancer |
Carcinoma Colorectal Neoplasms Melanoma Triple Negative Breast Neoplasms Nasopharyngeal Carcinoma Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Breast Neoplasms Neoplasms by Site Breast Diseases Skin Diseases Intestinal Neoplasms Gastrointestinal Neoplasms |
Digestive System Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Nevi and Melanomas Skin Neoplasms Nasopharyngeal Neoplasms Pharyngeal Neoplasms Otorhinolaryngologic Neoplasms |