Phase 1 Study of INBRX-109 in Advanced or Metastatic Solid Tumors (Ph1 INBRX-109 (Study Part 3))
Research type
Research Study
Full title
An Open-Label, Multicenter, First-in-Human, Phase 1 Dose-Escalation and Multicohort Expansion Study of INBRX-109 in Subjects with Locally Advanced or Metastatic Solid Tumors, Including Sarcomas
IRAS ID
1009103
Contact name
Miranda Fox
Contact email
Sponsor organisation
Inhibrx, Inc.
Clinicaltrials.gov Identifier
Research summary
Cancer is a condition where cells in the body grow and reproduce uncontrollably. It may begin in one part of the body before spreading to other areas destroying surrounding healthy tissue in a process known as metastasis. Globally, cancer is the second leading cause of death, with the number of new cases expected to rise. In cancer that has progressively become worse known as solid malignancies, metastatic spread, and systematic disease accounts for approximately 90% of cancer-related deaths. Tumours, which are growth of cancer cells, evolve mechanisms that allow them to resist being destroyed by the immune system. Despite progress made over the past few decades, there remains a need for the development of targeted interventions for advanced solid tumours.
The therapy being investigated in this study, INBRX-109, is a medication developed by Inhibrix Inc. that has been designed to target cancerous cells and trigger their death whilst preserving normal cells.
This is a Phase 1/2, open-label study of INBRX-109 in patients with locally advanced or metastatic solid tumours, including sarcomas. The study is being conducted to better understand how INBRX-109 affects people with specific types of advanced cancers when given in combination with chemotherapy called irinotecan and/or temozolomide (TMZ). Participants will be placed into one of two groups (cohorts) group C3, if they have Ewing sarcoma, a type of cancer that occurs in the bones or soft tissues or in group C5, if they have (SDH)-deficient solid tumours or GIST, a type of cancer in the digestive tract. The purpose of this study is to learn about the effects of INBRX-109 on cancer; and to see how safe INBRX-109 is for participants with cancer.
The study will include a total of approximately 130 participants. Of these, 50 adults and adolescents will participate in group C3 and 20 adults in group C5, at approximately 30 study sites in 4 European Union countries, the United States, and the United Kingdom.REC name
London - City & East Research Ethics Committee
REC reference
24/LO/0327
Date of REC Opinion
24 May 2024
REC opinion
Further Information Favourable Opinion