Tests INBRX-109 in people with advanced solid tumors, including sarcomas
Tests INBRX-109, an antibody, in people with advanced solid tumors like Ewing sarcoma.
Plain-language title generated from the registry record
Registry title: Phase 1 Study of INBRX-109 in Subjects With Locally Advanced or Metastatic Solid Tumors Including Sarcomas
Key facts
- Where
- Barcelona and Madrid, SpainSee the 3 sites
- Phase
- Phase 1
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people with advanced or metastatic solid tumors, including Ewing sarcoma and colorectal adenocarcinoma, who have measurable disease and good daily functioning.
- Age
- 12 to under 85 years for Ewing sarcoma; 18 to under 85 years for other tumors.
- Sex
- Men and women can join.
- Disease stage
- Locally advanced or metastatic disease with measurable tumors. Ewing sarcoma that is unresectable, relapsed or refractory, with a classical fusion. Colorectal adenocarcinoma that has failed earlier treatment.
- Earlier treatment
- Ewing sarcoma: at least 1 but no more than 2 prior lines of systemic treatment. Colorectal adenocarcinoma: 1 prior line without irinotecan, or 2 to 3 prior lines and no earlier FTD/TPI. No earlier DR5 agonist treatment.
- Biomarker or test result
- Ewing sarcoma with a classical fusion. Archival tissue or a fresh cancer biopsy must be available.
Main reasons for not taking part
- Earlier treatment with DR5 agonists
- Anticancer therapy within 4 weeks or 5 half-lives before the first dose
- Hepatitis B, hepatitis C or HIV infection
- Symptomatic active brain tumors or brain metastases, or multiple sclerosis
- Chronic liver disease or a significant heart condition in the last 3 months
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 12 and 85 years old?
Source: NCT03715933, who can take part
Where in Spain
- Hospital de la Santa Creu i Sant PauBarcelona, SpainTaking people
- Hospital Universitari Vall d'HebronBarcelona, SpainTaking people
- Hospital Clínico San CarlosMadrid, SpainTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Inhibrx Biosciences, Inc
- Trial code
- NCT03715933EU 2023-508139-29-00
- Record updated
- 8 September 2026
- Original description
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).Read full original descriptionShow less
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
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).
Inclusion: Males or females aged ≥12 to less than 85 years for Ewing sarcoma and 18 to less than 85 years of age for other tumors; 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 who have failed 1 (one) prior line of systemic therapy that did not include irinotecan; Colorectal adenocarcinoma: Patients who have failed 2 but no more than 3 prior lines of systemic therapy and are FTD/TPI-naïve; Measurable disease as defined by RECISTv1.1 (or modified RECIST for mesothelioma) criteria; Adequate hematologic, coagulation, hepatic and renal function as defined per protocol; 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); Estimated life expectancy of at least 12 weeks; Availability of archival tissue or fresh cancer biopsy are mandatory.
Exclusion: Prior treatment with or exposure to DR5 agonists; 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; 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; Subject has undergone allogeneic hematopoietic stem cell or bone marrow transplantation within the last 5 years. Exceptions per protocol; Prior or concurrent malignancies. Exceptions per protocol; Acute viral or toxic liver disease within 12 months prior to the first dose of study drug; Known sensitivity or contraindications to the following drugs:; Ewing sarcoma: irinotecan or TMZ; colorectal adenocarcinoma: FU, leucovorin, irinotecan, bevacizumab or FTP/TPI; Clinically significant cardiac condition, including myocardial infarction, uncontrolled angina, cerebrovascular accident, or other acute uncontrolled heart disease less than 3 months prior to enrollment; 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; Major surgery within 4 weeks prior to enrollment on this trial; Systemic infection requiring antibiotics within 2 weeks prior to the first dose of study drug; Allergy or sensitivity to INBRX-109 or known allergies to CHO-produced antibodies; Hematologic malignancies; 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; Evidence or history of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection; Chronic liver diseases including fatty liver. Exception: Patients < 45 years old with fatty liver disease may be accepted as long as adequate hepatic function as defined in the inclusion/exclusion criteria is confirmed; Other exclusion criteria per protocol.