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

Brief Title

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

Official Title

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

Brief Summary

      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).
    

Study Phase

Phase 1

Study Type

Interventional

Primary Outcome

Frequency and severity of adverse events of INBRX-109

Secondary Outcome

 Area under the serum concentration time curve (AUC) of INBRX-109

Condition

Solid Tumors

Intervention

INBRX-109

Study Arms / Comparison Groups

 Dose Escalation

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

140

Start Date

October 10, 2018

Completion Date

December 2021

Primary Completion Date

August 2021

Eligibility Criteria

        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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Klaus Wagner, CMO, 858-500-7833, [email protected]

Location Countries

United States

Location Countries

United States

NCT ID

NCT03715933

Organization ID

Ph1 INBRX-109

Responsible Party

Sponsor

Study Sponsor

Inhibrx, Inc.

Study Sponsor

Klaus Wagner, CMO, Study Director, Inhibrx, Inc.

Verification Date

January 2021