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Closed (no longer recruiting)Last updated: 30 January 2024

STING: This phase I trial is combining to drugs (PDR001 and MIW815) for the treatment of advanced solid cancers and LymphomasA 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 summary

Summary

The purpose of this study is to characterize the safety, tolerability, pharmacokinetics, pharmacodynamics and antitumor activity of MIW815 (ADU-S100) in combination with PDR001. The study is comprised of two treatment arms. Group A will include patients with accessible solid tumors and lymphomas. This group will receive a fixed dose of PDR001 intravenous 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 intravenous on day 1 of every cycle and an intratumoral injection of MIW815 (ADU-S100) on day 1 of every cycle. Once the maximum tolerated dose and/or recommended dose for expansion is determined, the expansion part of the study will open.

Conditions

This trial is treating patients with advanced solid cancers or Lymphoma.

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

I

Trial Acronym

STING

More information

Trial Identifiers

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Trial sponsor

Novartis Pharmaceuticals

Scientific 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

Eligibility

Inclusion

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

Must have two biopsy accessible lesions:

Exclusion

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

Exclusion

  • You have certain types of non-cancer medical conditions.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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