Solid Tumor, AdultPhase 1NCT06098651
A Study of DCR-STAT3 in Adults With Solid Tumors
A Phase 1 study testing DCR-STAT3 in people with Solid Tumor, Adult and Refractory Tumor, run by Dicerna Pharmaceuticals, Inc., a Novo Nordisk company at 2 sites in United States.
Trial summary
This is a sequential, ascending-dose, multicenter study conducted in patients with refractory solid tumors designed to evaluate the safety, tolerability, and pharmacokinetics of DCR-STAT3. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Adult, Refractory Tumor
- What is being tested?
- DCR-STAT3
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 Aug 2023to 17 Sep 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Age
- ≥ 18 years of age inclusive, at the time of signing the informed consent.
- Type of Participant and Disease Characteristics
- 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 for which no standard therapy is available
- Demonstrated evidence of disease progression, via imaging, during or following standard therapy known to provide clinical benefit for their condition
- Demonstrated intolerance to standard therapy known to provide clinical benefit for their condition
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- Measurable disease according to RECIST version 1.1 (as determined by CT or MRI)
- Malignancy not currently amenable to surgical intervention due to medical contraindication or non-resectability of the tumor
- ECOG performance status of 0, 1, or 2, and an anticipated life expectancy of ≥ 3 months
- Weight
- BMI ≥ 18 kg/m2
- Sex
- Male participants are eligible to participate if they agree to the following during the study intervention period and for at least 24 weeks after the last dose of study intervention:
- Refrain from donating sperm
- AND, either:
- Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR
- Must agree to use a male condom when having sexual intercourse with a WOCBP who is not currently pregnant
- Female participants are eligible to participate if they are not pregnant or breastfeeding, and one of the following conditions applies:
- Is not a WOCBP OR
- Is a WOCBP and:
- is using a contraceptive method that is highly effective, with a failure rate of < 1%, as described in Section 10.4 during the study intervention period and for at least 24 weeks after the last dose of study intervention. The Investigator should evaluate the potential for contraceptive method failure (e.g., noncompliance, recently initiated) in relationship to the first dose of study intervention.
- must have a negative highly sensitive pregnancy test (serum as required by local regulations) on Day 1 of each cycle before the first dose of study intervention
Who cannot join
- Prior/Concomitant Therapy
- Other concurrent (within 28 days of Day 1, Cycle 1) chemotherapy, immunotherapy, or radiotherapy. Note that hormonal therapy (e.g., tamoxifen, LHRH agonists) is allowed.
- Requirement for palliative radiotherapy to lesions that are defined as target lesions by RECIST version 1.1 criteria at the time of study entry
- Continued compromise or inadequate recovery from a prior anti-neoplastic therapy
- Known hypersensitivity to any of the components of DCR-STAT3
- Long-term immunosuppressive therapy
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- Prior/Concurrent Clinical Study Experience
- Treatment with investigational therapy(ies) within 5 half-lives of the investigational therapy prior to the first scheduled day of dosing with DCR-STAT3, or 4 weeks if the half-life of the investigational agent is not known
- Diagnostic assessments - Seropositive for antibodies to HIV, HBV, or HCV at Screening (historical testing may be used if performed within the 3 months prior to screening). NOTE: In participants with previous treatment for hepatitis C with direct-acting HCV medication and seropositivity for HCV, or in participants with prior infection and spontaneous resolution, HCV RNA must be undetectable (at least 2 negative HCV RNA tests at least 12 weeks apart), and the HCV infection must have been resolved or cured > 3 years prior to initial dosing with the investigational medication.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Next Oncology
Dallas, Texas, 75039
Next Oncology
San Antonio, Texas, 78229
About this study
Official title: An Open-label, Phase 1, Dose-ranging Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Intravenous DCR-STAT3 in Adults With Refractory Solid Tumors
This is a sequential, ascending-dose, multicenter study conducted in patients with refractory solid tumors designed to evaluate the safety, tolerability, and pharmacokinetics of DCR-STAT3.
Read the detailed description
The primary goal of this first-in-human study is to assess the safety and tolerability of DCR-STAT3 in adults with refractory solid tumors. Secondary study goals are to evaluate potential antitumor effects of STAT3 knockdown, as assessed by circulating blood biomarkers indicative of immune activation, as well as any direct impact on tumor size by appropriate imaging and RECIST 1.1 criteria. Antitumor effects will be evaluated for DCR-STAT3 as a monotherapy.
- Conditions
- Solid Tumor, Adult, Refractory Tumor
- Being tested
- DCR-STAT3
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DCR-STAT3Drug
DCR-STAT3 is a sterile, preservative-free solution in WFI that will be diluted in a suitable admixture diluent (0.9% normal saline) prior to IV infusion.
| Study group | Role | What they receive |
|---|---|---|
| DCR-STAT3 | Experimental | DCR-STAT3 Receives: Drug: DCR-STAT3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events and dose limiting toxicities
safety and tolerability
Measured: Cycle 1 (8 weeks)
Severity of adverse events
measured according to CTCAE 5.0 criteria
Measured: Cycle 1 (8 weeks)
Secondary outcomes (2)
Pharmacokinetic (AUC)
Area under the plasma concentration versus time curve
Measured: Day 1 and Day 29 of Cycle 1 (each cycle is 8 weeks)
Pharmacokinetic (Urine)
Urinary excretion
Measured: Day 1 and Day 29 of Cycle 1 (each cycle is 8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study start14 Aug 2023
- Primary completion17 Sep 2025
- Study completion17 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor, 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
- Model description
- This is a sequential, ascending-dose, multicenter study conducted in patients with refractory solid tumors designed to evaluate the safety, tolerability, and pharmacokinetics of DCR-STAT3. Participants will be enrolled across 4 ascending-dose cohorts. Each treatment cycle will consist of multiple IV doses. Dose escalation decisions will be evaluated in conjunction with a Safety Review Committee (SRC). The study will be conducted over 4 dose cohorts in a 3+3 design and will initially comprise 12 to 24 participants. Should one DLT occur within a given cohort, an additional 3 participants will be enrolled in that cohort. Two cohorts will be backfilled or expanded to a total of at least 10 participants in each cohort, for a total enrollment of approximately 32 participants. The cohorts and associated dose levels will be chosen in a data-driven fashion as the study proceeds, in conjunction with the SRC.
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dicerna Pharmaceuticals, Inc., a Novo Nordisk company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Hanrahan, MD MPH, Study director, Dicerna Phamaceuticals, a Novo Nordisk Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06098651
- Sponsor's protocol ID
- DCR-STAT3-101
- Status last verified
- Sep 2026
- First submitted
- 28 Sep 2023
- Last updated
- 29 Sep 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 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Phase 1, Dose-ranging Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Intravenous DCR-STAT3 in Adults With Refractory Solid Tumors
- ClinicalTrials.gov ID
- NCT06098651
- Acronym / sponsor ID
- DCR-STAT3-101
- Conditions
- Solid Tumor, Adult, Refractory Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Dicerna Pharmaceuticals, Inc., a Novo Nordisk companyIndustry (pharma, biotech, devices)
- Study start
- 14 Aug 2023 (actual)
- Primary completion
- 17 Sep 2025 (actual)
- Study completion
- 17 Sep 2025 (actual)
- First posted
- 24 Oct 2023 (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 sequential, ascending-dose, multicenter study conducted in patients with refractory solid tumors designed to evaluate the safety, tolerability, and pharmacokinetics of DCR-STAT3.
Detailed description
The primary goal of this first-in-human study is to assess the safety and tolerability of DCR-STAT3 in adults with refractory solid tumors. Secondary study goals are to evaluate potential antitumor effects of STAT3 knockdown, as assessed by circulating blood biomarkers indicative of immune activation, as well as any direct impact on tumor size by appropriate imaging and RECIST 1.1 criteria. Antitumor effects will be evaluated for DCR-STAT3 as a monotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a sequential, ascending-dose, multicenter study conducted in patients with refractory solid tumors designed to evaluate the safety, tolerability, and pharmacokinetics of DCR-STAT3. Participants will be enrolled across 4 ascending-dose cohorts. Each treatment cycle will consist of multiple IV doses. Dose escalation decisions will be evaluated in conjunction with a Safety Review Committee (SRC). The study will be conducted over 4 dose cohorts in a 3+3 design and will initially comprise 12 to 24 participants. Should one DLT occur within a given cohort, an additional 3 participants will be enrolled in that cohort. Two cohorts will be backfilled or expanded to a total of at least 10 participants in each cohort, for a total enrollment of approximately 32 participants. The cohorts and associated dose levels will be chosen in a data-driven fashion as the study proceeds, in conjunction with the SRC.
| Arm | Type | Receives |
|---|---|---|
| DCR-STAT3 | Experimental | Drug: DCR-STAT3DCR-STAT3 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Age
- ≥ 18 years of age inclusive, at the time of signing the informed consent.
- Type of Participant and Disease Characteristics
- 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 for which no standard therapy is available
- Demonstrated evidence of disease progression, via imaging, during or following standard therapy known to provide clinical benefit for their condition
Key exclusion criteria (9 listed)
- Prior/Concomitant Therapy
- Prior/Concurrent Clinical Study Experience
- Diagnostic assessments - Seropositive for antibodies to HIV, HBV, or HCV at Screening (historical testing may be used if performed within the 3 months prior to screening). NOTE: In participants with previous treatment for hepatitis C with direct-acting HCV medication and seropositivity for HCV, or in participants with prior infection and spontaneous resolution, HCV RNA must be undetectable (at least 2 negative HCV RNA tests at least 12 weeks apart), and the HCV infection must have been resolved or cured > 3 years prior to initial dosing with the investigational medication.
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-STAT3DCR-STAT3 is a sterile, preservative-free solution in WFI that will be diluted in a suitable admixture diluent (0.9% normal saline) prior to IV infusion. | Drug | DCR-STAT3 |
Primary outcome
Incidence of adverse events and dose limiting toxicities
Time frame: Cycle 1 (8 weeks)
safety and tolerability
Severity of adverse events
Time frame: Cycle 1 (8 weeks)
measured according to CTCAE 5.0 criteria
2 secondary outcomes
Pharmacokinetic (AUC)
Time frame: Day 1 and Day 29 of Cycle 1 (each cycle is 8 weeks)
Pharmacokinetic (Urine)
Time frame: Day 1 and Day 29 of Cycle 1 (each cycle is 8 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 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.
John Hanrahan, MD MPH study director
Dicerna Phamaceuticals, a Novo Nordisk Company
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-STAT3 in people with Solid Tumor, Adult and Refractory Tumor, 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 22 inclusion and 9 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: finished, as of the sponsor's last update on 29 Sep 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of adverse events and dose limiting toxicities (time frame: Cycle 1 (8 weeks)). The study lists 2 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 29 Sep 2026.