Phase 1 Study of INBRX-109 in Subjects With Locally Advanced or Metastatic Solid Tumors Including Sarcomas
NCT ID: NCT03715933
Last Updated: 2025-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
321 participants
INTERVENTIONAL
2018-10-08
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Expansion Malignant Pleural Mesothelioma (Complete)
Subjects with malignant pleural mesothelioma will be treated with single-agent INBRX-109 at either the MTD or RP2D.
INBRX-109
Tetravalent DR5 Agonist Antibody
Expansion Gastric Adenocarcinoma (Complete)
Subjects with gastric adenocarcinoma will be treated with single-agent INBRX-109 at either the MTD or RP2D.
INBRX-109
Tetravalent DR5 Agonist Antibody
Expansion Colorectal Adenocarcinoma (Complete)
Subjects with colorectal (CRC) adenocarcinoma will be treated with single-agent INBRX-109 at either the MTD or RP2D.
INBRX-109
Tetravalent DR5 Agonist Antibody
Expansion Sarcomas (Complete)
Subjects with certain sarcoma subtypes will be treated with single-agent INBRX-109 at either the MTD or RP2D.
INBRX-109
Tetravalent DR5 Agonist Antibody
Combination Expansion Malignant Pleural Mesothelioma (Complete)
Subjects with malignant pleural mesothelioma will be treated with INBRX-109 in combination with chemotherapies (carboplatin, cisplatin, carboplatin and pemetrexed, or cisplatin and pemetrexed)
INBRX-109
Tetravalent DR5 Agonist Antibody
carboplatin
chemotherapy
pemetrexed
chemotherapy
Combination Expansion Pancreatic Adenocarcinoma (Complete)
Subjects with pancreatic adenocarcinoma will be treated with INBRX-109 in combination with 5FU/irinotecan based chemotherapy
INBRX-109
Tetravalent DR5 Agonist Antibody
Irinotecan
Chemotherapy
Leucovorin
chemotherapy
Fluorouracil
chemotherapy
Combination Expansion Ewing Sarcoma
Subjects with Ewing Sarcoma will be treated with INBRX-109 in combination with irinotecan and temozolomide
INBRX-109
Tetravalent DR5 Agonist Antibody
Irinotecan
Chemotherapy
Temozolomide
Chemotherapy
Combination Expansion Colorectal Adenocarcinoma (Complete)
Subjects with colorectal adenocarcinoma will be treated with INBRX-109 in combination with FOLFIRI based chemotherapy
INBRX-109
Tetravalent DR5 Agonist Antibody
Irinotecan
Chemotherapy
Leucovorin
chemotherapy
Fluorouracil
chemotherapy
Expansion Solid Tumors (Complete)
Subjects with Solid tumors and high BMI will be treated with single-agent INBRX-109 at either the MTD or RP2D.
INBRX-109
Tetravalent DR5 Agonist Antibody
Combination Expansion SDH-deficient solid tumors or GIST (Complete)
Subjects with SDH-deficient solid tumors or GIST will be treated with INBRX-109 in combination with temozolomide
INBRX-109
Tetravalent DR5 Agonist Antibody
Temozolomide
Chemotherapy
Dose Escalation (Complete)
INBRX-109 will be escalated (3+3 design) in subjects with locally advanced or metastatic solid tumors including sarcomas.
INBRX-109
Tetravalent DR5 Agonist Antibody
Interventions
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INBRX-109
Tetravalent DR5 Agonist Antibody
Irinotecan
Chemotherapy
Temozolomide
Chemotherapy
carboplatin
chemotherapy
pemetrexed
chemotherapy
Leucovorin
chemotherapy
Fluorouracil
chemotherapy
Eligibility Criteria
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Inclusion Criteria
2. Part 3 combination therapy expansion tumor types:
* Histologically confirmed Ewing sarcoma with a classical fusion: Patients with locally advanced or metastatic, unresectable, relapsed, or refractory disease who have received at least 1 but no more than 2 prior lines of systemic treatment with a preferred first line chemotherapy regimens.
* Colorectal adenocarcinoma: Patients with locally advanced or metastatic, unresectable disease, who have received at least 2 but no more than 3 prior lines of systemic therapy.
3. Measurable disease as defined by RECISTv1.1 (or modified RECIST for mesothelioma) criteria.
4. Adequate hematologic, coagulation, hepatic and renal function as defined per protocol.
5. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1, or Karnofsky Performance Status score of ≥60, or Lansky Play-Performance Scale for Children score ≥60 (for patients less than 16 years).
6. Estimated life expectancy of at least 12 weeks.
7. Availability of archival tissue or fresh cancer biopsy are mandatory.
Exclusion Criteria
2. Receipt of any anticancer therapy (including investigational agents) within 4 weeks or within 5 half-lives prior to the first dose of study treatment. Exceptions per protocol.
3. Allergy or sensitivity to INBRX-109 or known allergies to CHO-produced antibodies.
4. Receipt of radiotherapy within 4 weeks prior to the first dose of study treatment, and liver-directed within 12 months prior to the first dose of study drug.
5. Subject has undergone allogeneic hematopoietic stem cell or bone marrow transplantation within the last 5 years. Exceptions per protocol.
6. Prior or concurrent malignancies. Exceptions per protocol.
7. Hematologic malignancies.
8. Symptomatic active primary CNS tumors, leptomeningeal disease, and CNS metastases. Exceptions per protocol. Patients with any evidence or history of multiple sclerosis (MS) or other demyelinating disorders are excluded.
10. Acute viral or toxic liver disease within 12 months prior to the first dose of study drug.
11. Evidence or history of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection.
12. Known sensitivity or contraindications to the following drugs:
* Ewing sarcoma: irinotecan or TMZ
* colorectal adenocarcinoma: FU, leucovorin, or irinotecan
13. Clinically significant cardiac condition, including myocardial infarction, uncontrolled angina, cerebrovascular accident, or other acute uncontrolled heart disease less than 3 months prior to enrollment.
14. Acute, hemodynamically significant deep vein thrombosis or clinically significant pulmonary embolism not resolved or stable for at least 3 months prior to the start of study treatment.
15. Major surgery within 4 weeks prior to enrollment on this trial.
16. Systemic infection requiring antibiotics within 2 weeks prior to the first dose of study drug.
12 Years
85 Years
ALL
No
Sponsors
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Inhibrx Biosciences, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Lead
Role: STUDY_DIRECTOR
Inhibrx Biosciences, Inc
Locations
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HonorHealth Research Institute
Scottsdale, Arizona, United States
Precision NextGen Oncology and Research
Beverly Hills, California, United States
City of Hope
Duarte, California, United States
Valkyrie Clinical Trials
Los Angeles, California, United States
University of California, San Diego (UCSD) - Moores Cancer Center
San Diego, California, United States
University of California, San Francisco (UCSF)
San Francisco, California, United States
Sarcoma Oncology Center
Santa Monica, California, United States
University of Colorado Hospital
Aurora, Colorado, United States
Emory University - Winship Cancer Institute
Atlanta, Georgia, United States
The University of Chicago
Chicago, Illinois, United States
University of Michigan
Ann Arbor, Michigan, United States
START Midwest Michigan, PC
Grand Rapids, Michigan, United States
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
New York, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
Children's Hospital of Philadelphia- Center for Childhood Cancer Research
Philadelphia, Pennsylvania, United States
University of Pennsylvania Abramson Cancer Center
Philadelphia, Pennsylvania, United States
Vanderbilt University School of Medicine
Nashville, Tennessee, United States
UT MD Anderson Cancer Center
Houston, Texas, United States
NEXT Oncology
San Antonio, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
NEXT Oncology - Virginia
Fairfax, Virginia, United States
Centre Leon Berard
Lyon, , France
Gustave Roussy
Villejuif, , France
La Fondazione e l'Istituto di Candiolo
Candiolo, , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, , Italy
University Medical Center Groningen
Groningen, , Netherlands
Academisch Ziekenhuis Leiden
Leiden, , Netherlands
Hospital Universitario Vall d'Hebron
Barcelona, , Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Hospital Clinico San Carlos
Madrid, , Spain
Great North Children's Hospital
London, , United Kingdom
University College London Hospital
London, , United Kingdom
The Royal Marsden NHS Foundation Trust
London, , United Kingdom
Royal Manchester Children's Hospital
Manchester, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Care Advisors
Role: primary
Role: primary
Role: backup
Role: backup
References
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Subbiah V, Chawla SP, Conley AP, Wilky BA, Tolcher A, Lakhani NJ, Berz D, Andrianov V, Crago W, Holcomb M, Hussain A, Veldstra C, Kalabus J, O'Neill B, Senne L, Rowell E, Heidt AB, Willis KM, Eckelman BP. Preclinical Characterization and Phase I Trial Results of INBRX-109, A Third-Generation, Recombinant, Humanized, Death Receptor 5 Agonist Antibody, in Chondrosarcoma. Clin Cancer Res. 2023 Aug 15;29(16):2988-3003. doi: 10.1158/1078-0432.CCR-23-0974.
Other Identifiers
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Ph1 INBRX-109
Identifier Type: -
Identifier Source: org_study_id
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