Safety, Tolerability, and Pharmacokinetics of DCR-PDL1 in Adults With Solid Tumors

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 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

Conditions2

Locations2 sites

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