About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Sequential
Treatments tested in this trial
DCR-PDL1
DrugSolution for IV Infusion
Treatment groups
Trial outcomes
Primary outcomes
Incidence and Nature of Adverse Events (AEs)
Incidence of Dose-limiting Toxicities (DLTs)
Change From Baseline in Vital Signs: Oral, Tympanic, Temporal Artery Temperature
Vital signs will be measured in a semi-supine (i.e., semi-recumbent) position.
Change From Baseline in Vital Signs: Systolic and Diastolic Blood Pressure
Vital signs will be measured in a semi-supine (i.e., semi-recumbent) position.
Secondary outcomes
Pharmacokinetic Plasma Concentrations of DCR-PDL1
Pharmacokinetic Urine Concentrations of DCR-PDL1
Sponsors and contacts
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