Solid Tumors, AdultPhase 1NCT06504368
Safety, Tolerability, and Pharmacokinetics of DCR-PDL1 in Adults With Solid Tumors
A Phase 1 study testing DCR-PDL1 in people with Solid Tumors, Adult, run by Dicerna Pharmaceuticals, Inc., a Novo Nordisk company at 2 sites in United States.
Trial summary
The study will evaluate the safety, tolerability, and pharmacokinetics of intravenous DCR-PDL1 in adults with solid tumors. Participants will be enrolled in one of 4 ascending-dose cohorts. Each treatment cycle will consist of multiple intravenous (IV) doses. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors, Adult
- What is being tested?
- DCR-PDL1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesUnited States
- Study dates
- 29 May 2024to 31 Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female adults, aged greater than or equal to (≥) 18 years.
- Participants are required to have a documented, locally advanced or metastatic solid tumor malignancy, or non-Hodgkin's lymphoma
- that is refractory to standard therapy known to provide clinical benefit for their condition OR
- have demonstrated evidence of disease progression or relapse, via imaging, during or following standard therapy known to provide clinical benefit for their condition, OR
- have demonstrated intolerance to standard therapy known to provide clinical benefit for their condition. OR
- for which no standard therapy is available
Show all 10Show fewer
- Measurable disease according to RECIST version 1.1.
- Malignancy not currently amenable to surgical intervention.
- ECOG performance status of 0, 1, or 2, and an anticipated life expectancy of ≥ 3 months at the time of signing the informed consent.
- Other protocol defined inclusion criteria could apply
Who cannot join
- Participants with known CNS or leptomeningeal metastases not controlled by prior surgery or radiotherapy, or symptoms suggesting CNS involvement for which treatment is required.
- Other protocol defined exclusion criteria could apply
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
NEXT Oncology
Irving, Texas, 75039
- Recruiting
Next Oncology
San Antonio, Texas, 78229
About this study
Official title: An Open-Label, Phase 1, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Intravenous DCR-PDL1 in Adults With Solid Tumors
The study will evaluate the safety, tolerability, and pharmacokinetics of intravenous DCR-PDL1 in adults with solid tumors. Participants will be enrolled in one of 4 ascending-dose cohorts. Each treatment cycle will consist of multiple intravenous (IV) doses. Dose escalation decisions will be based on data collected during the dose-limiting toxicity (DLT) period.
- Conditions
- Solid Tumors, Adult
- Being tested
- DCR-PDL1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DCR-PDL1Drug
Solution for IV Infusion
| Study group | Role | What they receive |
|---|---|---|
| DCR-PDL1 | Experimental | Participants will receive multiple IV doses of DCR-PDL1 during each treatment cycle. Receives: Drug: DCR-PDL1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and Nature of Adverse Events (AEs)
Measured: Baseline to week 8
Incidence of Dose-limiting Toxicities (DLTs)
Measured: Baseline to week 8
Change From Baseline in Vital Signs: Oral, Tympanic, Temporal Artery Temperature
Vital signs will be measured in a semi-supine (i.e., semi-recumbent) position.
Measured: Baseline up to week 8
Change From Baseline in Vital Signs: Systolic and Diastolic Blood Pressure
Vital signs will be measured in a semi-supine (i.e., semi-recumbent) position.
Measured: Baseline up to week 8
Change From Baseline in Vital Signs: Pulse and Respiratory Rate
Vital signs will be measured in a semi-supine (i.e., semi-recumbent) position. Blood pressure and pulse measurements should be preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions.
Measured: Baseline up to week 8
Change from Baseline in 12-lead Electrocardiogram (ECG): Heart Rate and Pulse Rate
Measured: Baseline to week 8
Change from Baseline in 12-lead Electrocardiogram (ECG): QRS intervals
ECG recordings will be made in a semi-supine (i.e., semi-recumbent) position, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions.
Measured: Baseline to week 8
Change from Baseline in 12-lead Electrocardiogram (ECG): QT intervals
ECG recordings will be made in a semi-supine (i.e., semi-recumbent) position, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions.
Measured: Baseline to week 8
Change from Baseline in 12-lead Electrocardiogram (ECG): QTcF intervals (QT Interval Corrected by the Fridericia Formula)
ECG recordings will be made in a semi-supine (i.e., semi-recumbent) position, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions.
Measured: Baseline to week 8
Change from Baseline in Hematology Parameter: Red blood cells, White blood cells, Lymphocytes, Monocytes, Eosinophils, Neutrophils, Basophils and Platelets, Reticulocytes
Measured: Baseline to week 8
Change from Baseline in Hematology Parameter: Mean corpuscular volume (MCV)
Measured: Baseline to week 8
Change from Baseline in Hematology Parameter: Mean corpuscular hemoglobin (MCH)
Measured: Baseline to week 8
Change from Baseline in Hematology Parameter: Hemoglobin
Measured: Baseline to week 8
Change from Baseline in Hematology Parameter: Hematocrit and Mean corpuscular hemoglobin concentration (MCHC)
Measured: Baseline to week 8
Change from Baseline in Coagulation Parameter: International normalized ratio (INR)
Measured: Baseline to week 8
Change from Baseline in Coagulation Parameter: Prothrombin Time (PT) and Partial Thromboplastin Time (PTT)
Measured: Baseline to week 8
Change from Baseline in Coagulation Parameter: Fibrinogen
Measured: Baseline to week 8
Change from Baseline in Clinical Chemistry Parameter: Alanine transaminase (ALT), Aspartate transaminase (AST), Gamma-glutamyl transferase (GGT), Alkaline phosphatase (ALP), Lactate dehydrogenase (LDH) and Creatine kinase (CK)
Measured: Baseline to week 8
Change from Baseline in Clinical Chemistry Parameter: Total protein and Albumin
Measured: Baseline to week 8
Change from Baseline in Clinical Chemistry Parameter: Total bilirubin, Direct bilirubin, Fasting blood glucose, Creatinine and Blood urea nitrogen (BUN)
Measured: Baseline to week 8
Change from Baseline in Clinical Chemistry Parameter: Sodium, Chloride and Potassium
Measured: Baseline to week 8
Change from Baseline in Urinalysis Parameter: Glucose, Protein, Bilirubin and Urobilinogen
Measured: Baseline to week 8
Change from Baseline in Urinalysis Parameter: Specific Gravity
Measured: Baseline to week 8
Change from Baseline in Urinalysis Parameter: Potential of Hydrogen (pH) of Urine
Measured: Baseline to week 8
Change from Baseline in Urinalysis Parameter: Blood
Measured: Baseline to week 8
Change from Baseline in Urinalysis Parameter: Ketones and Nitrite
Measured: Baseline to week 8
Change from Baseline in Urinalysis Parameter: Leukocyte esterase
Measured: Baseline to week 8
Number of Participants with Change from Baseline in Physical Examination Findings: Cardiovascular, Respiratory, Gastrointestinal, and Neurological systems
A complete physical examination will include, at a minimum, assessments of the cardiovascular, respiratory, gastrointestinal, and neurological systems.
Measured: Baseline to week 8
Secondary outcomes (2)
Pharmacokinetic Plasma Concentrations of DCR-PDL1
Measured: Pre-dose up to 48 hours post-dose
Pharmacokinetic Urine Concentrations of DCR-PDL1
Measured: Up to 8 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start29 May 2024
- Primary completion1 Jun 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumors, AdultStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dicerna Pharmaceuticals, Inc., a Novo Nordisk company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 2834), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06504368
- Sponsor's protocol ID
- DCR-PDL1-101
- Status last verified
- Nov 2025
- First submitted
- 18 Jun 2024
- Last updated
- 6 Nov 2025
- 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 6 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Phase 1, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Intravenous DCR-PDL1 in Adults With Solid Tumors
- ClinicalTrials.gov ID
- NCT06504368
- Acronym / sponsor ID
- DCR-PDL1-101
- Conditions
- Solid Tumors, Adult
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Dicerna Pharmaceuticals, Inc., a Novo Nordisk companyIndustry (pharma, biotech, devices)
- Study start
- 29 May 2024 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 16 Jul 2024 (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.
The study will evaluate the safety, tolerability, and pharmacokinetics of intravenous DCR-PDL1 in adults with solid tumors. Participants will be enrolled in one of 4 ascending-dose cohorts. Each treatment cycle will consist of multiple intravenous (IV) doses. Dose escalation decisions will be based on data collected during the dose-limiting toxicity (DLT) period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DCR-PDL1 | Experimental | Drug: DCR-PDL1Participants will receive multiple IV doses of DCR-PDL1 during each treatment cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female adults, aged greater than or equal to (≥) 18 years.
- Participants are required to have a documented, locally advanced or metastatic solid tumor malignancy, or non-Hodgkin's lymphoma
- Measurable disease according to RECIST version 1.1.
- Malignancy not currently amenable to surgical intervention.
- ECOG performance status of 0, 1, or 2, and an anticipated life expectancy of ≥ 3 months at the time of signing the informed consent.
Key exclusion criteria (2 listed)
- Participants with known CNS or leptomeningeal metastases not controlled by prior surgery or radiotherapy, or symptoms suggesting CNS involvement for which treatment is required.
- Other protocol defined exclusion criteria could apply
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 |
|---|---|---|
| DCR-PDL1Solution for IV Infusion | Drug | DCR-PDL1 |
Primary outcome
Incidence and Nature of Adverse Events (AEs)
Time frame: Baseline to week 8
Incidence of Dose-limiting Toxicities (DLTs)
Time frame: Baseline to week 8
Change From Baseline in Vital Signs: Oral, Tympanic, Temporal Artery Temperature
Time frame: Baseline up to week 8
Vital signs will be measured in a semi-supine (i.e., semi-recumbent) position.
Change From Baseline in Vital Signs: Systolic and Diastolic Blood Pressure
Time frame: Baseline up to week 8
Vital signs will be measured in a semi-supine (i.e., semi-recumbent) position.
Change From Baseline in Vital Signs: Pulse and Respiratory Rate
Time frame: Baseline up to week 8
Vital signs will be measured in a semi-supine (i.e., semi-recumbent) position. Blood pressure and pulse measurements should be preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions.
Change from Baseline in 12-lead Electrocardiogram (ECG): Heart Rate and Pulse Rate
Time frame: Baseline to week 8
Change from Baseline in 12-lead Electrocardiogram (ECG): QRS intervals
Time frame: Baseline to week 8
ECG recordings will be made in a semi-supine (i.e., semi-recumbent) position, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions.
Change from Baseline in 12-lead Electrocardiogram (ECG): QT intervals
Time frame: Baseline to week 8
ECG recordings will be made in a semi-supine (i.e., semi-recumbent) position, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions.
Change from Baseline in 12-lead Electrocardiogram (ECG): QTcF intervals (QT Interval Corrected by the Fridericia Formula)
Time frame: Baseline to week 8
ECG recordings will be made in a semi-supine (i.e., semi-recumbent) position, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions.
Change from Baseline in Hematology Parameter: Red blood cells, White blood cells, Lymphocytes, Monocytes, Eosinophils, Neutrophils, Basophils and Platelets, Reticulocytes
Time frame: Baseline to week 8
Change from Baseline in Hematology Parameter: Mean corpuscular volume (MCV)
Time frame: Baseline to week 8
Change from Baseline in Hematology Parameter: Mean corpuscular hemoglobin (MCH)
Time frame: Baseline to week 8
Change from Baseline in Hematology Parameter: Hemoglobin
Time frame: Baseline to week 8
Change from Baseline in Hematology Parameter: Hematocrit and Mean corpuscular hemoglobin concentration (MCHC)
Time frame: Baseline to week 8
Change from Baseline in Coagulation Parameter: International normalized ratio (INR)
Time frame: Baseline to week 8
Change from Baseline in Coagulation Parameter: Prothrombin Time (PT) and Partial Thromboplastin Time (PTT)
Time frame: Baseline to week 8
Change from Baseline in Coagulation Parameter: Fibrinogen
Time frame: Baseline to week 8
Change from Baseline in Clinical Chemistry Parameter: Alanine transaminase (ALT), Aspartate transaminase (AST), Gamma-glutamyl transferase (GGT), Alkaline phosphatase (ALP), Lactate dehydrogenase (LDH) and Creatine kinase (CK)
Time frame: Baseline to week 8
Change from Baseline in Clinical Chemistry Parameter: Total protein and Albumin
Time frame: Baseline to week 8
Change from Baseline in Clinical Chemistry Parameter: Total bilirubin, Direct bilirubin, Fasting blood glucose, Creatinine and Blood urea nitrogen (BUN)
Time frame: Baseline to week 8
Change from Baseline in Clinical Chemistry Parameter: Sodium, Chloride and Potassium
Time frame: Baseline to week 8
Change from Baseline in Urinalysis Parameter: Glucose, Protein, Bilirubin and Urobilinogen
Time frame: Baseline to week 8
Change from Baseline in Urinalysis Parameter: Specific Gravity
Time frame: Baseline to week 8
Change from Baseline in Urinalysis Parameter: Potential of Hydrogen (pH) of Urine
Time frame: Baseline to week 8
Change from Baseline in Urinalysis Parameter: Blood
Time frame: Baseline to week 8
Change from Baseline in Urinalysis Parameter: Ketones and Nitrite
Time frame: Baseline to week 8
Change from Baseline in Urinalysis Parameter: Leukocyte esterase
Time frame: Baseline to week 8
Number of Participants with Change from Baseline in Physical Examination Findings: Cardiovascular, Respiratory, Gastrointestinal, and Neurological systems
Time frame: Baseline to week 8
A complete physical examination will include, at a minimum, assessments of the cardiovascular, respiratory, gastrointestinal, and neurological systems.
2 secondary outcomes
Pharmacokinetic Plasma Concentrations of DCR-PDL1
Time frame: Pre-dose up to 48 hours post-dose
Pharmacokinetic Urine Concentrations of DCR-PDL1
Time frame: Up to 8 hours post-dose
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 6 Nov 2025.
- 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.
Clinical Transparency (dept. 2834) study director
Novo Nordisk A/S
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DCR-PDL1 in people with Solid Tumors, Adult, run by Dicerna Pharmaceuticals, Inc., a Novo Nordisk company at 2 sites in United States.
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 10 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 6 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Contact Novo Nordisk ((+1) 866-867-7178, clinicaltrials@novonordisk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and Nature of Adverse Events (AEs) (time frame: Baseline to week 8). The study lists 28 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 6 Nov 2025.