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

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.

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