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

NCT ID: NCT06504368

Last Updated: 2025-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-29

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Solid Tumors, Adult

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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DCR-PDL1

Participants will receive multiple IV doses of DCR-PDL1 during each treatment cycle.

Group Type EXPERIMENTAL

DCR-PDL1

Intervention Type DRUG

Solution for IV Infusion

Interventions

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DCR-PDL1

Solution for IV Infusion

Intervention Type DRUG

Eligibility Criteria

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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.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dicerna Pharmaceuticals, Inc., a Novo Nordisk company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Transparency (dept. 2834)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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NEXT Oncology

Irving, Texas, United States

Site Status RECRUITING

Next Oncology

San Antonio, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Novo Nordisk

Role: CONTACT

Phone: (+1) 866-867-7178

Email: [email protected]

Other Identifiers

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DCR-PDL1-101

Identifier Type: -

Identifier Source: org_study_id