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

Conditions

• Advanced/Metastatic Solid Tumors or Lymphomas

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• ADU-S100 — DRUG
• ipilimumab — BIOLOGICAL

Study Details

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.

Key Dates

Start date

Apr 28, 2016

Status verified

Dec 2021

Primary completion

Dec 11, 2019

Completion

Aug 6, 2020

Study Design

Enrollment

47 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Dose escalation monotherapy
  ADU-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
• Experimental: Dose escalation combination
  ADU-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

Primary Outcome Measure

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

Locations (7)

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