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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03715933
Recruitment Status : Recruiting
First Posted : October 23, 2018
Last Update Posted : January 13, 2023
Sponsor:
Information provided by (Responsible Party):
Inhibrx, Inc.

Study Description
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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).

Condition or disease Intervention/treatment Phase
Solid Tumors Malignant Pleural Mesothelioma Gastric Adenocarcinoma Colorectal Adenocarcinoma Sarcoma Pancreatic Adenocarcinoma Ewing Sarcoma Chondrosarcoma Drug: INBRX-109 Drug: Carboplatin Drug: Cisplatin Drug: Pemetrexed Drug: 5-fluorouracil Drug: Irinotecan Drug: Temozolomide Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : October 10, 2018
Estimated Primary Completion Date : August 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
Tetravalent DR5 Agonist Antibody
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
Tetravalent DR5 Agonist Antibody
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
Tetravalent DR5 Agonist Antibody
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
Tetravalent DR5 Agonist Antibody
Experimental: Expansion Sarcomas
Subjects with certain sarcoma subtypes will be treated with single-agent INBRX-109 at either the MTD or RP2D.
 Drug: INBRX-109
Tetravalent DR5 Agonist Antibody
Experimental: Combination Expansion Malignant Pleural Mesothelioma
Subjects with malignant pleural mesothelioma will be treated with INBRX-109 in combination with chemotherapies (carboplatin, cisplatin, carboplatin and pemetrexed, or cisplatin and pemetrexed)
 Drug: INBRX-109
Tetravalent DR5 Agonist Antibody

Drug: Carboplatin
Chemotherapy

Drug: Cisplatin
Chemotherapy

Drug: Pemetrexed
Chemotherapy
Experimental: Combination Expansion Pancreatic Adenocarcinoma
Subjects with pancreatic adenocarcinoma will be treated with INBRX-109 in combination with 5FU/irinotecan based chemotherapy
 Drug: INBRX-109
Tetravalent DR5 Agonist Antibody

Drug: 5-fluorouracil
Chemotherapy

Drug: Irinotecan
Chemotherapy
Experimental: Combination Expansion Ewing Sarcoma
Subjects with Ewing Sarcoma will be treated with INBRX-109 in combination with irinotecan and temozolomide
 Drug: INBRX-109
Tetravalent DR5 Agonist Antibody

Drug: Irinotecan
Chemotherapy

Drug: Temozolomide
Chemotherapy
Experimental: Combination Expansion Colorectal Adenocarcinoma
Subjects with colorectal adenocarcinoma will be treated with INBRX-109 in combination with FOLFIRI based chemotherapy
 Drug: INBRX-109
Tetravalent DR5 Agonist Antibody

Drug: 5-fluorouracil
Chemotherapy

Drug: Irinotecan
Chemotherapy
Experimental: Expansion Solid Tumors
Subjects with Solid tumors and high BMI will be treated with single-agent INBRX-109 at either the MTD or RP2D.
 Drug: INBRX-109
Tetravalent DR5 Agonist Antibody
Experimental: Combination Expansion SDH-deficient solid tumors or GIST
Subjects with SDH-deficient solid tumors or GIST will be treated with INBRX-109 in combination with temozolomide
 Drug: INBRX-109
Tetravalent DR5 Agonist Antibody

Drug: Temozolomide
Chemotherapy


Outcome Measures
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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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

  • 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.

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, 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.
Contacts and Locations
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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
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Contact: Miranda Fox, Trial Manager 858-500-7833 clinicaltrials@inhibrx.com
Contact: Kevin Bayer, Clinical Director clinicaltrials@inhibrx.com

Locations
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United States, Arizona
HonorHealth Research Institute Recruiting
Scottsdale, Arizona, United States, 85258
Contact: Joyce Schaffer, RN    480-323-1791    mailto:clinicaltrials@honorhealth.com   
Principal Investigator: Sunil Sharma, MD         
United States, California
City of Hope Recruiting
Duarte, California, United States, 91010
Contact: Shamili Thiagarajan    626-218-0979    sthiagarajan@coh.org   
Contact: New Patient Services Coordinator    1-800-826-4673    newpatientref@coh.org   
Principal Investigator: Mark Agulnik, MD         
Valkyrie Clinical Trials Recruiting
Los Angeles, California, United States, 90067
Contact: Francisco Capilla    213-926-1844    francisco@alacritycare.com   
Principal Investigator: David Berz, MD         
Sarcoma Oncology Center Recruiting
Santa Monica, California, United States, 90403
Contact: Victoria Chua-Alcala    310-552-9999    vchua@sarcomaoncology.com   
Principal Investigator: Sant P Chawla, MD         
United States, Colorado
University of Colorado Hospital Recruiting
Aurora, Colorado, United States, 80045
Contact: Ana Nguyen    720-848-4394    ana.nguyen@ucdenver.edu   
Principal Investigator: Christopher Lieu, MD         
United States, Georgia
Emory University - Winship Cancer Institute Recruiting
Atlanta, Georgia, United States, 30322
Contact: Suzanne Scott    404-778-4083      
Principal Investigator: Maria Diab, MD         
United States, Illinois
The University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Bianca Hill    773-834-1472    bhill22@medicine.bsd.uchicago.edu   
Contact: Buerkley Rose    773-834-4002    brose@bsd.uchicago.edu   
Principal Investigator: Hedy Kindler, MD         
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Irina Veridyan    734-647-8902    limendel@med.umich.edu   
Principal Investigator: Rashmi Chugh, MD         
START Midwest Michigan, PC Recruiting
Grand Rapids, Michigan, United States, 49546
Contact: Katie Robinson    616-389-1739    Katie.Robinson@startmidwest.com   
Principal Investigator: Nehal Lakhani, MD         
United States, New York
Haley Phelan Recruiting
New York, New York, United States, 10021
Contact: Haley C Phelan    646-888-6952      
Principal Investigator: Ciara Kelly, MD         
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Heather Kearney    216-444-3409    keaneyh@ccf.org   
Principal Investigator: Dale Shepard, MD         
United States, Pennsylvania
University of Pennsylvania Abramson Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19106
Contact: Sarcoma Research       SarcomaResearch@uphs.upenn.edu   
Principal Investigator: Lee Hartner, MD         
United States, Texas
UT MD Anderson Cancer Center 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 Active, not recruiting
San Antonio, Texas, United States, 78229
United States, Virginia
NEXT Oncology - Virginia Recruiting
Fairfax, Virginia, United States, 22031
Contact: Melissa Hackmaster       mhackmaster@nextoncology.com   
Principal Investigator: Alexander Spira, MD         
Sponsors and Collaborators
Inhibrx, Inc.
Investigators
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Study Director: Vasily Andrianov, MD Inhibrx, Inc.
More Information
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Responsible Party: Inhibrx, Inc.
ClinicalTrials.gov Identifier: NCT03715933    
Other Study ID Numbers: Ph1 INBRX-109
First Posted: October 23, 2018    Key Record Dates
Last Update Posted: January 13, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Inhibrx, Inc.:
Phase 1
Phase 1 Clinical Trial
Solid Tumors
Sarcoma
Pleural Mesothelioma
Stomach Cancer
Colorectal Cancer
Colon Cancer
 Rectal Cancer
DR5
Gastric Adenocarcinoma
Colorectal Adenocarcinoma
Pancreatic Adenocarcinoma
Ewing Sarcoma
Chondrosarcoma
Additional relevant MeSH terms:
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Adenocarcinoma
Sarcoma
Mesothelioma
Mesothelioma, Malignant
Sarcoma, Ewing
Chondrosarcoma
Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Connective and Soft Tissue
Adenoma
Neoplasms, Mesothelial
Lung Neoplasms
Respiratory Tract Neoplasms
 Thoracic Neoplasms
Neoplasms by Site
Pleural Neoplasms
Lung Diseases
Respiratory Tract Diseases
Osteosarcoma
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Carboplatin
Fluorouracil
Irinotecan
Pemetrexed
Temozolomide
Antineoplastic Agents
Antimetabolites