Evaluating DCR-PDL1 for adults with solid tumors
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
Run by Novo Nordisk A/S · NCT06504368 · Data updated 2026-11-12
This study is testing a new treatment called DCR-PDL1 given through an IV to see if it's safe and works for adults with solid tumors.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 32 (estimated) |
| Sponsor | Novo Nordisk A/S Industry-sponsored |
| Locations | 2 sites (Irving, Texas and 1 other locations) |
| Status | Recruiting |
| Started | May 29, 2024 |
| Main results expected | June 1, 2026 |
| Study ends | December 31, 2027 |
| Registry record updated | November 6, 2025 |
| Trial ID | NCT06504368 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 and older with locally advanced or metastatic solid tumors that have not responded to standard treatments.
✕Probably not a fit
Patients with solid tumors that are amenable to surgical intervention or those who have not exhausted standard therapy options may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study assesses the safety, tolerability, and pharmacokinetics of DCR-PDL1 administered intravenously to adults with solid tumors. Participants will be assigned to one of four ascending-dose cohorts, with treatment cycles involving multiple IV doses. The study will monitor dose-limiting toxicities to inform dose escalation decisions throughout the trial.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors that are resistant to standard therapies.
How similar studies have gone: While this approach is being explored in this specific context, similar studies evaluating novel therapies for solid tumors have shown promise in the past.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 * 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 Exclusion Criteria: * 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
Where it's running
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NEXT Oncology
Irving, Texas, United States Recruiting -
Next Oncology
San Antonio, Texas, United States Recruiting
Study contacts
- Study coordinator: Novo Nordisk
- Email: clinicaltrials@novonordisk.com
- Phone: (+1) 866-867-7178
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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ABSK141 for advanced solid tumors with KRAS G12D mutation
This trial tests an oral drug called ABSK141 to see if it is safe and helps adults with advanced solid tumors that have a KRAS G12D mutation.
-
HMPL-A580 for adults with advanced or metastatic solid tumors
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-
GC203 TIL therapy for advanced solid tumors in adults
This trial tests GC203 tumor-infiltrating lymphocyte therapy in adults with solid tumors that have not responded to standard treatments.
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HMPL-A251 for adults with advanced or metastatic HER2-expressing solid tumors
This trial will test a new drug called HMPL-A251 to see if it is safe and helps adults with unresectable or metastatic HER2-expressing solid tumors.
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PANK-003 cell injection with chemotherapy for solid tumors
This study is testing if PANK-003 cell injections combined with chemotherapy can help people who have had surgery for solid tumors like lung or breast cancer feel better and improve their chances of recovery.
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Using low-dose chemotherapy with controlled blood sugar to treat advanced solid tumors
This study is testing if giving low-dose chemotherapy while keeping blood sugar levels low can help patients with advanced solid tumors that haven't responded to other treatments.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.