Carcinoma, Non-Small-Cell LungPhase 1NCT03891953
Study of Safety and Efficacy of DKY709 Alone or in Combination With PDR001 in Patients With Advanced Solid Tumors.
A Phase 1 study testing DKY709 and PDR001 in people with Carcinoma, Non-Small-Cell Lung and Melanoma, run by Novartis Pharmaceuticals at 9 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung, Melanoma, Nasopharyngeal Carcinoma
- What is being tested?
- DKY709 and PDR001
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 9 sitesin 6 countries
- Study dates
- 7 May 2019to 25 Jun 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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)
- 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
Trial locations and contacts
9 sites in 6 countries.
9 sites in 6 countries
United States3 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
Tennessee Oncology
Nashville, Tennessee, 37203
Germany2 sites
Novartis Investigative Site
Dresden, Saxony, 01307
Novartis Investigative Site
Essen, 45147
About this study
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
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
- Being tested
- DKY709, PDR001
- Keywords
- Non-small Cell Lung Cancer, Melanoma, Nasopharyngeal Carcinoma, Microsatellite Stable Colorectal Cancer, Triple Negative Breast Cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Melanoma, Nasopharyngeal Carcinoma, Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DKY709Drug
Novel immunomodulatory agent
PDR001Drug
Also called Spartalizumab
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
| Study group | Role | What they receive |
|---|---|---|
| DKY709 | Experimental | DKY709 monotherapy Receives: Drug: DKY709 |
| DKY709 + PDR001 | Experimental | Combination therapy with DKY709 and PDR001 Receives: Drug: DKY709; Drug: PDR001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of DKY709 single agent treatment or DKY709 in combination with PDR001.
Incidence and severity of AEs and SAEs
Measured: 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.
Measured: 1 Month
Tolerability of DKY709 single agent treatment or DKY709 in combination with PDR001.
Incidence and severity of AEs and SAEs
Measured: 24 months
Secondary outcomes (8)
AUC of DKY709 and PDR001
AUC
Measured: 24 months
Cmax of DKY709 and PDR001
Cmax
Measured: 24 months
Tmax of DKY709 and PDR001
Tmax
Measured: 24 months
Half-life of DKY709 and PDR001
Half-life
Measured: 24 months
Progression Free Survival (PFS)
Determine PFS in each part of the study
Measured: 24 months
Best Overall Response (BOR)
Determine BOR in each part of the study
Measured: 24 months
Duration of Response (DOR)
Determine DOR in each part of the study
Measured: 24 months
Time to Progression (TTP)
Determine TTP in each part of the study
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2019
- Study start7 May 2019
- Primary completion25 Jun 2027 (estimated)
- Study completion25 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03891953
- Sponsor's protocol ID
- CDKY709A12101C
- Other IDs
- 2018-002580-26, 2018
- Status last verified
- Oct 2026
- First submitted
- 26 Mar 2019
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03891953
- Acronym / sponsor ID
- CDKY709A12101C
- 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
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 7 May 2019 (actual)
- Primary completion
- 25 Jun 2027 (estimated)
- Study completion
- 25 Jun 2027 (estimated)
- First posted
- 27 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DKY709 | Experimental | Drug: DKY709DKY709 monotherapy |
| DKY709 + PDR001 | Experimental | Drug: DKY709, Drug: PDR001Combination therapy with DKY709 and PDR001 |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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:
Key exclusion criteria (19 listed)
- 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:
- Clinically significant cardiac disease or impaired cardiac function, including any of the following:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DKY709Novel immunomodulatory agent | Drug | DKY709, DKY709 + PDR001 |
| PDR001Also: SpartalizumabPDR001 is a high-affinity, ligand-blocking, humanized IgG4 monoclonal antibody directed against PD-1 that blocks the binding of PD-L1 and PD-L2 | Drug | DKY709 + PDR001 |
Primary outcome
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
8 secondary outcomes
AUC of DKY709 and PDR001
Time frame: 24 months
Cmax of DKY709 and PDR001
Time frame: 24 months
Tmax of DKY709 and PDR001
Time frame: 24 months
Half-life of DKY709 and PDR001
Time frame: 24 months
Progression Free Survival (PFS)
Time frame: 24 months
Best Overall Response (BOR)
Time frame: 24 months
Duration of Response (DOR)
Time frame: 24 months
Time to Progression (TTP)
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DKY709 and PDR001 in people with Carcinoma, Non-Small-Cell Lung and Melanoma, run by Novartis Pharmaceuticals at 9 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Germany, Hong Kong, Japan, Spain and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of DKY709 single agent treatment or DKY709 in combination with PDR001. (time frame: 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.