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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorDicerna Pharmaceuticals, Inc., a Novo Nordisk company

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • DCR-PDL1

    Drug

    Solution for IV Infusion

Treatment groups

32 Participants
are divided into 1 treatment group
Group A: DCR-PDL1Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence and Nature of Adverse Events (AEs)

Time frame
Baseline to week 8
2

Incidence of Dose-limiting Toxicities (DLTs)

Time frame
Baseline to week 8
3

Change From Baseline in Vital Signs: Oral, Tympanic, Temporal Artery Temperature

Vital signs will be measured in a semi-supine (i.e., semi-recumbent) position.

Time frame
Baseline up to week 8
4

Change From Baseline in Vital Signs: Systolic and Diastolic Blood Pressure

Vital signs will be measured in a semi-supine (i.e., semi-recumbent) position.

Time frame
Baseline up to week 8

Secondary outcomes

1

Pharmacokinetic Plasma Concentrations of DCR-PDL1

Time frame
Pre-dose up to 48 hours post-dose
2

Pharmacokinetic Urine Concentrations of DCR-PDL1

Time frame
Up to 8 hours post-dose

Other outcomes

Sponsors and contacts

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