Experimental drug DCR-STAT3 tested in patients with stubborn cancers
NCT ID NCT06098651
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage trial tested an experimental drug called DCR-STAT3 in 26 adults with solid tumors that had stopped responding to standard treatments. The main goal was to check the drug's safety and how the body processes it. Researchers gave increasing doses to find the best and safest amount.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- DCR-STAT3 (an experimental drug given intravenously)
- What this could lead to
- If successful, this could lead to a new treatment option for patients with hard-to-treat solid tumors that have not responded to standard therapies.
- What could go wrong
- This is a very early (Phase 1) trial with only 26 participants, so safety and dosing are still being figured out. The drug may not work or could have side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
26 people
The number who actually took part.
- Started
-
Aug 2023
- Finished
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Sep 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 * 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: 1. Refrain from donating sperm AND, either: 2. 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 3. 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: 1. Is not a WOCBP OR 2. 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 Exclusion Criteria: 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 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Next Oncology
Dallas, Texas, 75039, United States
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Next Oncology
San Antonio, Texas, 78229, United States
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