Phase 1 Study of INBRX-109 in Subjects With Locally Advanced or Metastatic Solid Tumors Including Sarcomas

  • Interventional
  • Recruiting
  • NCT03715933
Eligibility Details Visit Clinicaltrials.gov

An Open-Label, Multicenter, First-in-Human, Dose-Escalation Phase 1 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).

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

Inclusion Criteria:

         - 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 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 Part 2.

        Exclusion Criteria:

         - 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, non-alcoholic fatty liver disease, 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.

At a Glance

National Government IDNCT03715933

IRB#IRB18-1226

Lead SponsorInhibrx, Inc.

Lead PhysicianHedy Kindler

Collaborator(s)N/A

EligibilityAll
18 Years and up
Recruiting