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

Description

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.

Conditions

Solid Tumors, Adult

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Study Overview

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Study Details

Study 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.

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

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

Condition
Solid Tumors, Adult
Intervention / Treatment

-

Contacts and Locations

San Antonio

Next Oncology, San Antonio, Texas, United States, 78229

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Dicerna Pharmaceuticals, Inc., a Novo Nordisk company,

Clinical Transparency (dept. 2834), STUDY_DIRECTOR, Novo Nordisk A/S

Study Record Dates

2027-12-31