Study of the Safety and Efficacy of MIW815 With PDR001 to Patients With Advanced/Metastatic Solid Tumors or Lymphomas

  • Interventional
  • Not Recruiting
  • NCT03172936
Eligibility Details Visit Clinicaltrials.gov

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

The purpose of this study is to characterize the safety, tolerability, pharmacokinetics, pharmacodynamics and antitumor activity of MIW815 (ADU-S100) in combination with PDR001.

This is a Phase Ib, multi-center, open-label study to characterize the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary antitumor activity of MIW815(ADU-S100) in combination with the PD-1 checkpoint inhibitor PDR001. Two different schedules will be explored in two dose escalation groups in accessible cutaneous or subcutaneous lesions, as well as an optional dose confirmation group exploring intratumoral injection of viscerally located lesions.

     Group A will include patients with accessible solid tumors and lymphomas. This group will receive a fixed dose of PDR001 i.v. on day 1 of every 28 day cycle and intratumoral injections of MIW815 (ADU-S100) on days 1, 8 and 15 of every 28 day cycle. Group B will include patients with accessible solid tumors and lymphomas. This group will receive a fixed dose of PDR001 i.v. on day 1 of every cycle and an intratumoral injection of MIW815 (ADU-S100) on day 1 of every cycle.

     Once the dose and dose schedule has been confirmed, the dose expansion part of the study will open. The main purpose of the expansion part is to further assess the safety and tolerability, as well as preliminary anti-tumor activity, of the study treatment at the maximum tolerated dose and/or recommended dose for expansion. .

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

Inclusion Criteria:

        ECOG ≤ 1 Willing to undergo tumor biopsies from injected and distal lesions

        Must have two biopsy accessible lesions:

        Exclusion Criteria:

        Symptomatic or untreated leptomeningeal disease. Presence of symptomatic central nervous system 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 infection. Active Epstein-Barr virus, hepatitis B virus or hepatitis C virus Malignant disease, other than that being treated in this study

At a Glance

National Government IDNCT03172936

IRB#IRB17-0603

Lead SponsorNovartis Pharmaceuticals

Lead PhysicianRandy Sweis

Collaborator(s)N/A

EligibilityAll
18 Years and up
Not Recruiting