Safety, Tolerability, and Pharmacokinetics of DCR-PDL1 in 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
Dicerna Pharmaceuticals, Inc., a Novo Nordisk company
32 participants
May 29, 2024
INTERVENTIONAL
Conditions
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. Dose escalation decisions will be based on data collected during the dose-limiting toxicity (DLT) period.
Eligibility
Inclusion Criteria9
- 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.
Exclusion Criteria1
- Participants with known CNS or leptomeningeal metastases not controlled by prior surgery or radiotherapy, or symptoms suggesting CNS involvement for which treatment is required.
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Interventions
Solution for IV Infusion
Locations(2)
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NCT06504368