Clinical trial · Interventional
Safety, Tolerability, and Pharmacokinetics of DCR-PDL1 in Adults With Solid Tumors
An Open-Label, Phase 1, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Intravenous DCR-PDL1 in Adults With Solid Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumors, Adult | Adult Solid Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DCR-PDL1 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- DCR-PDL1
- description
- Participants will receive multiple IV doses of DCR-PDL1 during each treatment cycle.
- interventionNames
- Drug: DCR-PDL1
Primary outcomes (28)
- measure
- Incidence and Nature of Adverse Events (AEs)
- timeFrame
- Baseline to week 8
- measure
- Incidence of Dose-limiting Toxicities (DLTs)
- timeFrame
- Baseline to week 8
- measure
- Change From Baseline in Vital Signs: Oral, Tympanic, Temporal Artery Temperature
- timeFrame
- Baseline up to week 8
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available