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

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ClinicalTrials.gov Identifier: NCT03715933
Recruitment Status : Recruiting
First Posted : October 23, 2018
Last Update Posted : December 3, 2018
Sponsor:
Information provided by (Responsible Party):
Inhibrx, Inc.

Brief Summary:
This is a first-in-human, open-label, non-randomized, two-part phase 1 trial of INBRX-109, which is a recombinant humanized multivalent antibody targeting the human death receptor 5 (DR5).

Condition or disease Intervention/treatment Phase
Solid Tumors Malignant Pleural Mesothelioma Gastric Adenocarcinoma Colorectal Adenocarcinoma Sarcoma Drug: INBRX-109 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : October 5, 2018
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : July 2020


Arm Intervention/treatment
Experimental: Dose Escalation
INBRX-109 will be escalated (3+3 design) in subjects with locally advanced or metastatic solid tumors including sarcomas.
Drug: INBRX-109
The active ingredient of INBRX-109 is a recombinant, humanized, multivalent antibody that targets the human death receptor 5 (DR5).

Experimental: Expansion Malignant Pleural Mesothelioma
Subjects with malignant pleural mesothelioma will be treated with single-agent INBRX-109 at either the MTD or RP2D.
Drug: INBRX-109
The active ingredient of INBRX-109 is a recombinant, humanized, multivalent antibody that targets the human death receptor 5 (DR5).

Experimental: Expansion Gastric Adenocarcinoma
Subjects with gastric adenocarcinoma will be treated with single-agent INBRX-109 at either the MTD or RP2D.
Drug: INBRX-109
The active ingredient of INBRX-109 is a recombinant, humanized, multivalent antibody that targets the human death receptor 5 (DR5).

Experimental: Expansion Colorectal Adenocarcinoma
Subjects with colorectal (CRC) adenocarcinoma will be treated with single-agent INBRX-109 at either the MTD or RP2D.
Drug: INBRX-109
The active ingredient of INBRX-109 is a recombinant, humanized, multivalent antibody that targets the human death receptor 5 (DR5).




Primary Outcome Measures :
  1. Frequency and severity of adverse events of INBRX-109 [ Time Frame: Up to 2 years ]
    Adverse events will be assessed and severity assigned by using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0.

  2. Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of INBRX-109 [ Time Frame: Up to 2 years ]
    The MTD and/or RP2D of INBRX-109 will be determined.


Secondary Outcome Measures :
  1. Area under the serum concentration time curve (AUC) of INBRX-109 [ Time Frame: Up to 2 years ]
    Area under the serum concentration time curve (AUC) of INBRX-109 will be determined.

  2. Immunogenicity of INBRX-109 [ Time Frame: Up to 2 years ]
    Frequency of ant-drug antibodies (ADA) against INBRX-109 will be determined.

  3. Maximum observed serum concentration (Cmax) of INBRX-109 [ Time Frame: Up to 2 years ]
    Maximum observed serum concentration (Cmax) of INBRX-109 will be determined.

  4. Trough observed serum concentration (Ctrough) of INBRX-109 [ Time Frame: Up to 2 years ]
    Trough observed serum concentration (Cmax) of INBRX-109 will be determined.

  5. Time to Cmax (Tmax) of INBRX-109 [ Time Frame: Up to 2 years ]
    Time to Cmax (Tmax) of INBRX-109 will be determined.


Other Outcome Measures:
  1. Anti-tumor activity of INBRX-109 [ Time Frame: Up to 2 years ]
    Tumor response will be determined by RECISTv1.1.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Part 1 Escalation: Histologically or cytologically-confirmed advanced/metastatic or nonresectable 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.
  • Part 2 Expansion Cohorts: Malignant pleural mesothelioma, gastric adenocarcinoma and colorectal adenocarcinoma 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03715933


Contacts
Contact: Kirsti Cook, DirClinOps 949-264-3862 clinicaltrials@inhibrx.com
Contact: Becca Penninga, ClinLead clinicaltrials@inhibrx.com

Locations
United States, Michigan
START Midwest Michigan, PC Recruiting
Grand Rapids, Michigan, United States, 49546
Contact: Katie Robinson    616-389-1739    Katie.Robinson@startmidwest.com   
United States, Texas
UT MD Anderson Cancer Center Not yet recruiting
Houston, Texas, United States, 77030
Contact: Gita Dangol    713-792-2913    GDangol@mdanderson.org   
Contact: Anna Lui    713-792-4843    ALui@mdanderson.org   
Principal Investigator: Vivek Subbiah, MD         
NEXT Oncology Recruiting
San Antonio, Texas, United States, 78240
Contact: Sarah Gomez    210-595-5670    sgomez@nextsat.com   
Sponsors and Collaborators
Inhibrx, Inc.
Investigators
Study Director: Klaus Wagner, CMO Inhibrx, Inc.

Responsible Party: Inhibrx, Inc.
ClinicalTrials.gov Identifier: NCT03715933     History of Changes
Other Study ID Numbers: Ph1 INBRX-109
First Posted: October 23, 2018    Key Record Dates
Last Update Posted: December 3, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Inhibrx, Inc.:
DR5
Phase 1
Phase 1 Clinical Trial
Solid Tumors
Sarcoma
Pleural Mesothelioma
Stomach Cancer
Colorectal Cancer
Colon Cancer
Rectal Cancer
Gastric Adenocarcinoma
Colorectal Adenocarcinoma

Additional relevant MeSH terms:
Adenocarcinoma
Sarcoma
Mesothelioma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective and Soft Tissue
Adenoma
Neoplasms, Mesothelial