Clinical Trials /

Safety and Efficacy of MIW815 (ADU-S100) +/- Ipilimumab in Patients With Advanced/Metastatic Solid Tumors or Lymphomas

NCT02675439

Description:

The purpose of this study is to characterize the safety, tolerability, pharmacokinetics, pharmacodynamics and antitumor activity of MIW815 (ADU-S100) administered via intratumoral injection as a single agent and in combination with ipilimumab.

Related Conditions:
  • Lymphoma
  • Malignant Solid Tumor
Recruiting Status:

Active, not recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Safety and Efficacy of MIW815 (ADU-S100) +/- Ipilimumab in Patients With Advanced/Metastatic Solid Tumors or Lymphomas
  • Official Title: A Phase I, Open Label, Multicenter Study of the Safety and Efficacy of MIW815 (ADU-S100) Administered by Intratumoral Injection to Patients With Advanced/Metastatic Solid Tumors or Lymphomas

Clinical Trial IDs

  • ORG STUDY ID: ADU-CL-07
  • NCT ID: NCT02675439

Conditions

  • Advanced/Metastatic Solid Tumors or Lymphomas

Interventions

DrugSynonymsArms
ADU-S100MIW815Dose escalation monotherapy
ipilimumabDose escalation combination

Purpose

The purpose of this study is to characterize the safety, tolerability, pharmacokinetics, pharmacodynamics and antitumor activity of MIW815 (ADU-S100) administered via intratumoral injection as a single agent and in combination with ipilimumab.

Trial Arms

NameTypeDescriptionInterventions
Dose escalation monotherapyExperimentalADU-S100 administered intratumorally on Days 1, 8 and 15 of each 28-day cycle until unacceptable toxicity, progressive disease and/or treatment is discontinued; starting dose 50 micrograms
  • ADU-S100
Dose escalation combinationExperimentalADU-S100 administered intratumorally on Days 1 and 8 of each 21-day cycle (starting dose 200 micrograms) and ipilimumab, i.v., (3 mg/kg) on day 1 of each 21-day cycle for the first 4 cycles. Dosing is continued until unacceptable toxicity, progressive disease and/or treatment is discontinued
  • ADU-S100
  • ipilimumab

Eligibility Criteria

        Inclusion Criteria:

          -  ECOG ≤ 1

          -  Willing to undergo tumor biopsies from injected and distal lesions

          -  Must have two biopsy accessible lesions:

               -  * one lesion must be ≥10 mm and <100 mm in longest diameter, accessible for
                  repeated intratumoral (IT) injection and accessible for baseline and on-treatment
                  biopsies.

                    -  a second (distal) lesion must be accessible for baseline and on-treatment
                       biopsy and must be distinct from the injected lesion.

                    -  tumors encasing major vascular structures (i.e., carotid artery or tumors
                       close to other vital organs), are not considered appropriate

        Exclusion Criteria:

          -  Patients who require local palliative measures such as XRT or surgery

          -  Symptomatic or untreated leptomeningeal disease.

          -  Presence of symptomatic central nervous system (CNS) metastases

          -  Impaired cardiac function or clinically significant cardiac disease

          -  Active autoimmune disease or a documented history of autoimmune disease, except
             vitiligo or resolved childhood asthma/atopy.

          -  Active infection requiring systemic antibiotic therapy.

          -  Known history of Human Immunodeficiency Virus (HIV) infection.

          -  Active Epstein-Barr virus (EBV), hepatitis B virus (HBV) or hepatitis C virus (HCV)

          -  Malignant disease, other than that being treated in this study.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Safety: Number of patients reporting treatment-related adverse events that qualify as dose-limiting toxicities
Time Frame:6 months from study start
Safety Issue:
Description:Number of patients reporting treatment-related adverse events that qualify as dose-limiting toxicities

Secondary Outcome Measures

Measure:Pharmacokinetics measured through plasma concentrations
Time Frame:6 months from study start
Safety Issue:
Description:measured through plasma concentrations
Measure:measurement of CD8-TIL counts
Time Frame:6 months from study start
Safety Issue:
Description:
Measure:RNA expression analysis of IFN gamma and immunomodulatory genes
Time Frame:6 months from study start
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Aduro Biotech, Inc.

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