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NCT06504368PHASE1Recruiting

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

Dicerna Pharmaceuticals, Inc., a Novo Nordisk company

Start Date

5/29/2024

Completion Date

12/31/2027

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 Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

DCR-PDL1

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Conditions

Solid Tumors, Adult

Locations

NEXT Oncology

Irving, Texas 75039

United States

Next Oncology

San Antonio, Texas 78229

United States