Evaluating DCR-PDL1 for adults with solid tumors
An Open-Label, Phase 1, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Intravenous DCR-PDL1 in Adults With Solid Tumors
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 |
| Enrollment | 32 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Novo Nordisk A/S Industry-sponsored |
| Locations | 2 sites (Irving, Texas and 1 other locations) |
| Trial ID | NCT06504368 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with locally advanced or metastatic solid tumors that have not responded to standard treatments.
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.
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 performed: While this approach is being explored in this specific context, similar studies evaluating novel therapies for solid tumors have shown promise in the past.
Eligibility criteria
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 this trial is running
Irving, Texas and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.