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

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

NCT ID: NCT06504368

Condition: Solid Tumors, Adult

Conditions: Official terms:
Neoplasms

Study type: Interventional

Study phase: Phase 1

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Sequential Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: DCR-PDL1
Description: Solution for IV Infusion
Arm group label: DCR-PDL1

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.

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Next Oncology

Address:
City: San Antonio
Zip: 78229
Country: United States

Status: Recruiting

Start date: May 29, 2024

Completion date: December 31, 2027

Lead sponsor:
Agency: Dicerna Pharmaceuticals, Inc., a Novo Nordisk company
Agency class: Industry

Source: Novo Nordisk A/S

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06504368