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Recruiting NCT06504368

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

Phase I Interventional Solid Tumors, Adult

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: DCR-PDL1.
Who it may be relevant to
Registry conditions: Solid Tumors, Adult. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

An Open-Label, Phase 1, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Intravenous DCR-PDL1 in Adults With Solid Tumors

Overview

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.

Interventions

  • Drug DCR-PDL1
    Solution for IV Infusion

Primary outcome measures

  • Incidence and Nature of Adverse Events (AEs) [Time frame: Baseline to week 8]
  • Incidence of Dose-limiting Toxicities (DLTs) [Time frame: Baseline to week 8]
  • Change From Baseline in Vital Signs: Oral, Tympanic, Temporal Artery Temperature [Time frame: Baseline up to week 8]
  • Change From Baseline in Vital Signs: Systolic and Diastolic Blood Pressure [Time frame: Baseline up to week 8]
  • Change From Baseline in Vital Signs: Pulse and Respiratory Rate [Time frame: Baseline up to week 8]
  • Change from Baseline in 12-lead Electrocardiogram (ECG): Heart Rate and Pulse Rate [Time frame: Baseline to week 8]
  • Change from Baseline in 12-lead Electrocardiogram (ECG): QRS intervals [Time frame: Baseline to week 8]
  • Change from Baseline in 12-lead Electrocardiogram (ECG): QT intervals [Time frame: Baseline to week 8]
  • Change from Baseline in 12-lead Electrocardiogram (ECG): QTcF intervals (QT Interval Corrected by the Fridericia Formula) [Time frame: Baseline to week 8]
  • Change from Baseline in Hematology Parameter: Red blood cells, White blood cells, Lymphocytes, Monocytes, Eosinophils, Neutrophils, Basophils and Platelets, Reticulocytes [Time frame: Baseline to week 8]
Secondary outcome measures (2)
  • Pharmacokinetic Plasma Concentrations of DCR-PDL1 [Time frame: Pre-dose up to 48 hours post-dose]
  • Pharmacokinetic Urine Concentrations of DCR-PDL1 [Time frame: Up to 8 hours post-dose]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 2 centers
  • NEXT Oncology — Irving
  • Next Oncology — San Antonio

Identifiers

NCT: NCT06504368 · DCR-PDL1-101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗