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

Dicerna Pharmaceuticals

Status and phase

Enrolling

Phase 1

Conditions

Solid Tumors, Adult

Treatments

Drug: DCR-PDL1

Study type

Interventional

Funder types

Industry

Identifiers

NCT06504368

DCR-PDL1-101

Details and patient eligibility

About

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.

Enrollment

32 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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