for people ages 18 years and up (full criteria)
study start
estimated completion
Principal Investigator
by Adam Burgoyne, MD (ucsd)
Headshot of Adam Burgoyne
Adam Burgoyne



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).

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


Solid Tumors, Malignant Pleural Mesothelioma, Gastric Adenocarcinoma, Colorectal Adenocarcinoma, Sarcoma, Pancreatic Adenocarcinoma, Ewing Sarcoma, Chondrosarcoma, Phase 1, Phase 1 Clinical Trial, Pleural Mesothelioma, Stomach Cancer, Colorectal Cancer, Colon Cancer, Rectal Cancer, DR5, Adenocarcinoma, Mesothelioma, Malignant Mesothelioma, Carboplatin, Fluorouracil, Irinotecan, Pemetrexed, Temozolomide, INBRX-109, Cisplatin, 5-fluorouracil, Expansion Malignant Pleural Mesothelioma, Expansion Gastric Adenocarcinoma, Expansion Colorectal Adenocarcinoma, Expansion Sarcomas, Expansion Solid Tumors


You can join if…

Open to people ages 18 years and up

  • Escalation: Histologically or cytologically-confirmed advanced/metastatic or non-resectable solid tumors, including sarcoma, that are refractory or intolerant to standard therapy, or for which no standard therapy exists that is likely to confer any clinical benefit.
  • Expansion Cohorts: Malignant pleural mesothelioma, gastric adenocarcinoma, colorectal adenocarcinoma, pancreatic adenocarcinoma and certain sarcoma subtypes (e.g., chondrosarcoma, Ewing sarcoma), GIST, and SDH-def solid tumors with locally advanced or metastatic, non-resectable disease, that are refractory or intolerant to standard therapy, or for which no standard therapy exists that is likely to confer any clinical benefit.
  • 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) of 0 or 1 for Part 1 and ECOG PS of 0, 1 or 2 for Parts 2 and 3.

You CAN'T join if...

  • Prior treatment with or exposure to DR5 agonists.
  • Receipt of investigational agents or devices, anticancer therapy and radiotherapy (with the exception of palliative localized radiation) within 4 weeks prior to the first dose of study drug, and liver-directed therapies (i.e., RFA, TACE/embolization, cryotherapy, SBRT) within 12 weeks prior to the first dose of study drug. Exceptions per protocol.
  • Subject has undergone allogeneic hematopoietic stem cell or bone marrow transplantation within the last 5 years. Exception: Participants who have had a stem cell or bone marrow transplant > 5 years ago are eligible for enrollment, as long as there are no symptoms of graft-versus-host disease (GVHD).
  • Prior or concurrent malignancies. Exception: Subjects with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessments of INBRX-109.
  • Hematologic malignancies.
  • Known or active primary central nervous system (CNS) tumors, leptomeningeal disease and CNS metastases. Exception: Subjects with previously treated, asymptomatic, and clinically stable CNS metastases may be allowed study entry if certain criteria apply.
  • Subjects with chronic liver diseases including but not limited to cirrhosis, NASH, alcohol-related liver disease, hemochromatosis, Wilson's disease, alpha-1 antitrypsin deficiency, hepatic or biliary autoimmune disorders (i.e., primary biliary cholangitis, autoimmune hepatitis).
  • Acute viral or toxic liver disease within 4 weeks prior to the first dose of study drug.
  • Evidence or history of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection.
  • Clinically significant cardiac condition, including myocardial infarction, uncontrolled angina, cerebrovascular accident, or other acute uncontrolled heart disease < 3 months; left ventricular ejection fraction (LVEF) < 50%; New York Heart Association (NYHA) Class III or IV congestive heart failure; or uncontrolled hypertension. Active, hemodynamically significant pulmonary embolism within 3 months prior to enrollment on this trial.
  • 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.
  • Part 3: Sensitivity or contraindications to carboplatin, cisplatin, pemetrexed, fluorouracil, irinotecan, or temozolomide.


  • University of California, San Diego (UCSD) - Moores Cancer Center not yet accepting patients
    San Diego California 92093 United States
  • Sarcoma Oncology Center accepting new patients
    Santa Monica California 90403 United States
  • Valkyrie Clinical Trials accepting new patients
    Los Angeles California 90067 United States
  • City of Hope accepting new patients
    Duarte California 91010 United States

Lead Scientist at University of California Health

  • Adam Burgoyne, MD (ucsd)
    Associate Clinical Professor, Medicine, Vc-health Sciences-schools. Authored (or co-authored) 33 research publications


accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
Inhibrx, Inc.
Phase 1 research study
Study Type
Expecting 240 study participants
Last Updated