Actively Recruiting
Phase 1 Study of INBRX-109 in Subjects With Locally Advanced or Metastatic Solid Tumors Including Sarcomas
Led by Inhibrx Biosciences, Inc · Updated on 2026-03-18
321
Participants Needed
35
Research Sites
425 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a first-in-human, open-label, non-randomized, three-part phase 1 trial of INBRX-109, which is a recombinant humanized tetravalent antibody targeting the human death receptor 5 (DR5).
CONDITIONS
Official Title
Phase 1 Study of INBRX-109 in Subjects With Locally Advanced or Metastatic Solid Tumors Including Sarcomas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males or females aged 12 to less than 85 years for Ewing sarcoma and 18 to less than 85 years for other tumors.
- Histologically confirmed Ewing sarcoma with a classical fusion, locally advanced or metastatic, unresectable, relapsed, or refractory, treated with 1 to 2 prior systemic therapies.
- Colorectal adenocarcinoma patients with locally advanced or metastatic, unresectable disease, treated with 2 to 3 prior systemic therapies.
- Measurable disease by RECISTv1.1 or modified RECIST for mesothelioma.
- Adequate blood, coagulation, liver, and kidney function per protocol.
- ECOG Performance Status of 0 or 1, or Karnofsky/Lansky score of at least 60 for children under 16.
- Estimated life expectancy of at least 12 weeks.
- Availability of archival tissue or fresh cancer biopsy.
You will not qualify if you...
- Prior treatment with or exposure to DR5 agonists.
- Receipt of any anticancer therapy, including investigational agents, within 4 weeks or 5 half-lives prior to study treatment, exceptions per protocol.
- Allergy or sensitivity to INBRX-109 or CHO-produced antibodies.
- Radiotherapy within 4 weeks prior to study treatment, or liver-directed radiotherapy within 12 months.
- Allogeneic hematopoietic stem cell or bone marrow transplant within last 5 years, exceptions per protocol.
- Prior or concurrent malignancies, exceptions per protocol.
- Hematologic malignancies.
- Symptomatic active primary CNS tumors, leptomeningeal disease, CNS metastases, or history of multiple sclerosis or demyelinating disorders.
- Chronic liver diseases including fatty liver, except patients under 45 with adequate liver function.
- Acute viral or toxic liver disease within 12 months.
- Evidence or history of hepatitis B, hepatitis C, or HIV infection.
- Known sensitivities to irinotecan, temozolomide, fluorouracil, or leucovorin depending on tumor type.
- Significant cardiac conditions within 3 months.
- Acute or unstable deep vein thrombosis or pulmonary embolism within 3 months.
- Major surgery within 4 weeks prior to enrollment.
- Systemic infection requiring antibiotics within 2 weeks prior to treatment.
- Other protocol-specified exclusion criteria.
AI-Screening
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Trial Site Locations
Total: 35 locations
1
HonorHealth Research Institute
Scottsdale, Arizona, United States, 85258
Completed
2
Precision NextGen Oncology and Research
Beverly Hills, California, United States, 90212
Actively Recruiting
3
City of Hope
Duarte, California, United States, 91010
Actively Recruiting
4
Valkyrie Clinical Trials
Los Angeles, California, United States, 90067
Actively Recruiting
5
University of California, San Diego (UCSD) - Moores Cancer Center
San Diego, California, United States, 92093
Actively Recruiting
6
University of California, San Francisco (UCSF)
San Francisco, California, United States, 94110
Actively Recruiting
7
Sarcoma Oncology Center
Santa Monica, California, United States, 90403
Actively Recruiting
8
University of Colorado Hospital
Aurora, Colorado, United States, 80045
Actively Recruiting
9
Emory University - Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Actively Recruiting
10
The University of Chicago
Chicago, Illinois, United States, 60637
Completed
11
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
12
START Midwest Michigan, PC
Grand Rapids, Michigan, United States, 49546
Actively Recruiting
13
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10021
Actively Recruiting
14
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
15
Oregon Health & Science University
Portland, Oregon, United States, 97239
Actively Recruiting
16
Children's Hospital of Philadelphia- Center for Childhood Cancer Research
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
17
University of Pennsylvania Abramson Cancer Center
Philadelphia, Pennsylvania, United States, 19106
Actively Recruiting
18
Vanderbilt University School of Medicine
Nashville, Tennessee, United States, 37232
Actively Recruiting
19
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
20
NEXT Oncology
San Antonio, Texas, United States, 78229
Completed
21
University of Virginia
Charlottesville, Virginia, United States, 22903
Actively Recruiting
22
NEXT Oncology - Virginia
Fairfax, Virginia, United States, 22031
Actively Recruiting
23
Centre Leon Berard
Lyon, France, 69008
Actively Recruiting
24
Gustave Roussy
Villejuif, France, 94805
Actively Recruiting
25
La Fondazione e l'Istituto di Candiolo
Candiolo, Italy, 10060
Actively Recruiting
26
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy, 20123
Actively Recruiting
27
University Medical Center Groningen
Groningen, Netherlands
Actively Recruiting
28
Academisch Ziekenhuis Leiden
Leiden, Netherlands
Actively Recruiting
29
Hospital Universitario Vall d'Hebron
Barcelona, Spain, 08035
Actively Recruiting
30
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08041
Actively Recruiting
31
Hospital Clinico San Carlos
Madrid, Spain, 28040
Actively Recruiting
32
Great North Children's Hospital
London, United Kingdom, EC4V 3BJ
Actively Recruiting
33
University College London Hospital
London, United Kingdom, NW1 2PG
Actively Recruiting
34
The Royal Marsden NHS Foundation Trust
London, United Kingdom, SW3 6JJ
Actively Recruiting
35
Royal Manchester Children's Hospital
Manchester, United Kingdom, M13 9WL
Actively Recruiting
Research Team
S
Study Director, -Inhibrx
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
11
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