Overview

This is a sequential, ascending-dose, multicenter study conducted in patients with refractory solid tumors designed to evaluate the safety, tolerability, and pharmacokinetics of DCR-STAT3.

Eligibility

Inclusion Criteria:

• Age
• ≥ 18 years of age inclusive, at the time of signing the informed consent.

Type of Participant and Disease Characteristics

• 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 for which no standard therapy is available
  • Demonstrated evidence of disease progression, via imaging, during or following standard therapy known to provide clinical benefit for their condition
  • Demonstrated intolerance to standard therapy known to provide clinical benefit for their condition
  • Measurable disease according to RECIST version 1.1 (as determined by CT or MRI)
  • Malignancy not currently amenable to surgical intervention due to medical contraindication or non-resectability of the tumor
  • ECOG performance status of 0, 1, or 2, and an anticipated life expectancy of ≥ 3 months

Weight

• BMI ≥ 18 kg/m2

Sex

        Male participants are eligible to participate if they agree to the following during the
        study intervention period and for at least 24 weeks after the last dose of study
        intervention:
          1. Refrain from donating sperm
             AND, either:
          2. Be abstinent from heterosexual intercourse as their preferred and usual lifestyle
             (abstinent on a long term and persistent basis) and agree to remain abstinent OR
          3. Must agree to use a male condom when having sexual intercourse with a WOCBP who is not
             currently pregnant
        Female participants are eligible to participate if they are not pregnant or breastfeeding,
        and one of the following conditions applies:
          1. Is not a WOCBP OR
          2. Is a WOCBP and:
             is using a contraceptive method that is highly effective, with a failure rate of < 1%,
             as described in Section 10.4 during the study intervention period and for at least 24
             weeks after the last dose of study intervention. The Investigator should evaluate the
             potential for contraceptive method failure (e.g., noncompliance, recently initiated)
             in relationship to the first dose of study intervention.
             must have a negative highly sensitive pregnancy test (serum as required by local
             regulations) on Day 1 of each cycle before the first dose of study intervention
             Exclusion Criteria:
             Prior/Concomitant Therapy
             - Other concurrent (within 28 days of Day 1, Cycle 1) chemotherapy, immunotherapy, or
             radiotherapy. Note that hormonal therapy (e.g., tamoxifen, LHRH agonists) is allowed.
             - Requirement for palliative radiotherapy to lesions that are defined as target
             lesions by RECIST version 1.1 criteria at the time of study entry
               -  Continued compromise or inadequate recovery from a prior anti-neoplastic therapy
               -  Known hypersensitivity to any of the components of DCR-STAT3
               -  Long-term immunosuppressive therapy
             Prior/Concurrent Clinical Study Experience
               -  Treatment with investigational therapy(ies) within 5 half-lives of the
                  investigational therapy prior to the first scheduled day of dosing with
                  DCR-STAT3, or 4 weeks if the half-life of the investigational agent is not known
             Diagnostic assessments - Seropositive for antibodies to HIV, HBV, or HCV at Screening
             (historical testing may be used if performed within the 3 months prior to screening).
             NOTE: In participants with previous treatment for hepatitis C with direct-acting HCV
             medication and seropositivity for HCV, or in participants with prior infection and
             spontaneous resolution, HCV RNA must be undetectable (at least 2 negative HCV RNA
             tests at least 12 weeks apart), and the HCV infection must have been resolved or cured
             > 3 years prior to initial dosing with the investigational medication.