RECRUITING

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

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Conditions

Solid Tumors, Adult

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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

Quick Facts

Study Start:2024-05-29
Study Completion:2027-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06504368

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male or female adults, aged greater than or equal to (≥) 18 years.
  2. * Participants are required to have a documented, locally advanced or metastatic solid tumor malignancy, or non-Hodgkin's lymphoma
  3. * that is refractory to standard therapy known to provide clinical benefit for their condition OR
  4. * have demonstrated evidence of disease progression or relapse, via imaging, during or following standard therapy known to provide clinical benefit for their condition, OR
  5. * have demonstrated intolerance to standard therapy known to provide clinical benefit for their condition. OR
  6. * for which no standard therapy is available
  7. * Measurable disease according to RECIST version 1.1.
  8. * Malignancy not currently amenable to surgical intervention.
  9. * ECOG performance status of 0, 1, or 2, and an anticipated life expectancy of ≥ 3 months at the time of signing the informed consent.
  10. * Other protocol defined inclusion criteria could apply
  1. * Participants with known CNS or leptomeningeal metastases not controlled by prior surgery or radiotherapy, or symptoms suggesting CNS involvement for which treatment is required.
  2. * Other protocol defined exclusion criteria could apply

Contacts and Locations

Study Contact

Novo Nordisk
CONTACT
(+1) 866-867-7178
clinicaltrials@novonordisk.com

Principal Investigator

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

Study Locations (Sites)

Next Oncology
San Antonio, Texas, 78229
United States

Collaborators and Investigators

Sponsor: Dicerna Pharmaceuticals, Inc., a Novo Nordisk company

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-29
Study Completion Date2027-12-31

Study Record Updates

Study Start Date2024-05-29
Study Completion Date2027-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Solid Tumors, Adult