Early access
Sign in
Taking people in United KingdomPhase 1

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.

Key facts

Who runs it
Inhibrx Biosciences, Inc
Where
London and Manchester, United KingdomSee the 4 sitesAlso in 5 other countries, 33 sites
Trial code
Registry title
Phase 1 Study of INBRX-109 in Subjects With Locally Advanced or Metastatic Solid Tumors Including Sarcomas
Status
Recruiting
Phase
Phase 1
People taking part
411 people, planned
Started
8 Oct 2018
Expected to end
Jun 2029
Type of study
Interventional, 14 groups
Treatments tested
  • INBRX-109
  • Irinotecan
  • Temozolomide
  • carboplatin
  • pemetrexed
  • Leucovorin
  • Fluorouracil
  • Bevacizumab
  • Trifluridine + Tipiracil
Record updated
8 September 2026

Who can take part

AI summary

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

The registry criteria, word for word

Show all 24 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Check if you might fit

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?

Where in United Kingdom

Also in 5 other countries, 33 sites

  • Great North Children's HospitalLondon, United KingdomContact: Quentin Campbell-Hewson, MD (principal investigator)Taking people
  • The Royal Marsden NHS Foundation TrustLondon, United KingdomContact: Andrea Napolitano, MD (principal investigator)Taking people
  • University College London HospitalLondon, United KingdomContact: Sandra Strauss, MD (principal investigator)Taking people
  • Royal Manchester Children's HospitalManchester, United KingdomContact: Bernadette Maria Dymphna Brennan (principal investigator)Taking people

About the trial

What the trial wants to find out

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).

The 14 groups in the trial

  • Dose Escalation (Complete)Treatment being tested

    INBRX-109 will be escalated (3+3 design) in subjects with locally advanced or metastatic solid tumors including sarcomas.

    Treatment: INBRX-109

  • Expansion Malignant Pleural Mesothelioma (Complete)Treatment being tested

    Subjects with malignant pleural mesothelioma will be treated with single-agent INBRX-109 at either the MTD or RP2D.

    Treatment: INBRX-109

  • Expansion Gastric Adenocarcinoma (Complete)Treatment being tested

    Subjects with gastric adenocarcinoma will be treated with single-agent INBRX-109 at either the MTD or RP2D.

    Treatment: INBRX-109

  • Expansion Colorectal Adenocarcinoma (Complete)Treatment being tested

    Subjects with colorectal (CRC) adenocarcinoma will be treated with single-agent INBRX-109 at either the MTD or RP2D.

    Treatment: INBRX-109

  • Expansion Sarcomas (Complete)Treatment being tested

    Subjects with certain sarcoma subtypes will be treated with single-agent INBRX-109 at either the MTD or RP2D.

    Treatment: INBRX-109

  • Combination Expansion Malignant Pleural Mesothelioma (Complete)Treatment being tested

    Subjects with malignant pleural mesothelioma will be treated with INBRX-109 in combination with chemotherapies (carboplatin, cisplatin, carboplatin and pemetrexed, or cisplatin and pemetrexed)

    Treatment: INBRX-109, carboplatin, and pemetrexed

  • Combination Expansion Pancreatic Adenocarcinoma (Complete)Treatment being tested

    Subjects with pancreatic adenocarcinoma will be treated with INBRX-109 in combination with 5FU/irinotecan based chemotherapy

    Treatment: INBRX-109, Irinotecan, Leucovorin, and Fluorouracil

  • Combination Expansion Adult Ewing SarcomaTreatment being tested

    Adult subjects with Ewing Sarcoma will be treated with INBRX-109 in combination with irinotecan and temozolomide

    Treatment: INBRX-109, Irinotecan, and Temozolomide

  • Combination Expansion Colorectal Adenocarcinoma (Complete)Treatment being tested

    Subjects with colorectal adenocarcinoma will be treated with INBRX-109 in combination with FOLFIRI based chemotherapy

    Treatment: INBRX-109, Irinotecan, Leucovorin, and Fluorouracil

  • Expansion Solid Tumors (Complete)Treatment being tested

    Subjects with Solid tumors and high BMI will be treated with single-agent INBRX-109 at either the MTD or RP2D.

    Treatment: INBRX-109

  • Combination Expansion SDH-deficient solid tumors or GIST (Complete)Treatment being tested

    Subjects with SDH-deficient solid tumors or GIST will be treated with INBRX-109 in combination with temozolomide

    Treatment: INBRX-109 and Temozolomide

  • Combination Expansion Colorectal Adenocarcinoma patients with FOLFIRI plus bevacizumabTreatment being tested

    Colorectal adenocarcinoma will be treated with INBRX-109 with FOLFIRI (FU, leucovorin, and irinotecan) plus bevacizumab

    Treatment: INBRX-109, Irinotecan, Leucovorin, Fluorouracil, and Bevacizumab

  • Combination Expansion Colorectal Adenocarcinoma with FTD/TPI plus bevacizumabTreatment being tested

    Colorectal adenocarcinoma will be treated with INBRX-109 with FTD/TPI plus bevacizumab

    Treatment: INBRX-109, Bevacizumab, and Trifluridine + Tipiracil

  • Combination Expansion Adolescent Ewing SarcomaTreatment being tested

    Adolescent (12 to \<18) subjects with Ewing Sarcoma will be treated with INBRX-109 in combination with irinotecan and temozolomide

    Treatment: INBRX-109, Irinotecan, and Temozolomide

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official 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
Plain-language title
Tests INBRX-109 in people with advanced solid tumors, including sarcomasGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT03715933, who can take part
Publications
Record updated
8 September 2026