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Study of INBRX-105 and INBRX-105 With Pembrolizumab in Patients With Solid Tumors Including Head and Neck Cancer (PDL1x41BB)

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: NCT03809624
Recruitment Status : Recruiting
First Posted : January 18, 2019
Last Update Posted : May 11, 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, nonrandomized, four-part trial to determine the safety profile and identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of INBRX-105 and INBRX-105 in combination with Pembrolizumab. INBRX-105, a next generation bispecific antibody, targets the human programmed death-ligand 1 (PD-L1) receptor and the human 4-1BB receptor. INBRX-105 provides localized conditional T-cell co-stimulation through 4-1BB agonism.

Condition or disease Intervention/treatment Phase
Metastatic Solid Tumors Non-small Cell Lung Cancer Melanoma Head and Neck Squamous Cell Carcinoma Gastric Adenocarcinoma Renal Cell Carcinoma Urothelial Carcinoma Esophageal Adenocarcinoma Nasopharyngeal Carcinoma Oropharyngeal Carcinoma Drug: INBRX-105 - PDL1x41BB antibody Drug: Pembrolizumab Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 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 2 Study of INBRX-105 and INBRX-105 in Combination With Pembrolizumab in Patients With Locally Advanced or Metastatic Solid Tumors
Actual Study Start Date : January 30, 2019
Estimated Primary Completion Date : August 2025
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: Single Agent Escalation
INBRX-105 will be escalated in patients with locally advanced or metastatic solid tumors.
 Drug: INBRX-105 - PDL1x41BB antibody
The active ingredient of INBRX-105 is a recombinant, humanized, bispecific IgG antibody that targets the human programmed death-ligand 1 (PD-L1) receptor and the human 4-1BB receptor.
Experimental: Expansion Cohort Non-small Cell Lung Cancer
Patients will be treated with single-agent INBRX-105 at either the MTD or RP2D.
 Drug: INBRX-105 - PDL1x41BB antibody
The active ingredient of INBRX-105 is a recombinant, humanized, bispecific IgG antibody that targets the human programmed death-ligand 1 (PD-L1) receptor and the human 4-1BB receptor.
Experimental: Expansion Cohort Melanoma
Patients will be treated with single-agent INBRX-105 at either the MTD or RP2D.
 Drug: INBRX-105 - PDL1x41BB antibody
The active ingredient of INBRX-105 is a recombinant, humanized, bispecific IgG antibody that targets the human programmed death-ligand 1 (PD-L1) receptor and the human 4-1BB receptor.
Experimental: Expansion Cohort PD-L1 Positive Basket
Patients with gastric or gastro-esophageal junction adenocarcinoma, renal cell carcinoma, and urothelial (transitional) cell carcinoma will be treated with single-agent INBRX-105 at either the MTD or RP2D.
 Drug: INBRX-105 - PDL1x41BB antibody
The active ingredient of INBRX-105 is a recombinant, humanized, bispecific IgG antibody that targets the human programmed death-ligand 1 (PD-L1) receptor and the human 4-1BB receptor.
Experimental: Expansion Cohort Nasopharyngeal or Oropharyngeal Carcinoma
Patients with head and neck squamous cell carcinoma (NPC or OPC) will be treated with single-agent INBRX-105 at either the MTD or RP2D.
 Drug: INBRX-105 - PDL1x41BB antibody
The active ingredient of INBRX-105 is a recombinant, humanized, bispecific IgG antibody that targets the human programmed death-ligand 1 (PD-L1) receptor and the human 4-1BB receptor.
Experimental: INBRX-105 Escalation in Combination with Pembrolizumab
INBRX-105 will be escalated in combination with Pembrolizumab in pateitns with locally advanced or metastatic solid tumors.
 Drug: INBRX-105 - PDL1x41BB antibody
The active ingredient of INBRX-105 is a recombinant, humanized, bispecific IgG antibody that targets the human programmed death-ligand 1 (PD-L1) receptor and the human 4-1BB receptor.

Drug: Pembrolizumab
Pembrolizumab 200 mg by intravenous (IV) infusion, given on Day 1 of each 21-day cycle.
Other Name: Keytruda
Experimental: Combination Expansion Cohort Non-small Cell Lung Cancer
CPI relapsed/refractory patients will be treated with INBRX-105 in combination with Pembrolizumab.
 Drug: INBRX-105 - PDL1x41BB antibody
The active ingredient of INBRX-105 is a recombinant, humanized, bispecific IgG antibody that targets the human programmed death-ligand 1 (PD-L1) receptor and the human 4-1BB receptor.

Drug: Pembrolizumab
Pembrolizumab 200 mg by intravenous (IV) infusion, given on Day 1 of each 21-day cycle.
Other Name: Keytruda
Experimental: Combination Expansion Cohort Melanoma
CPI relapsed/refractory patients will be treated with INBRX-105 in combination with Pembrolizumab.
 Drug: INBRX-105 - PDL1x41BB antibody
The active ingredient of INBRX-105 is a recombinant, humanized, bispecific IgG antibody that targets the human programmed death-ligand 1 (PD-L1) receptor and the human 4-1BB receptor.

Drug: Pembrolizumab
Pembrolizumab 200 mg by intravenous (IV) infusion, given on Day 1 of each 21-day cycle.
Other Name: Keytruda
Experimental: Combination Expansion Cohort Cohort PD-L1 Positive Basket
CPI-relapsed/refractory patients with head and neck squamous cell carcinoma, gastro-esophageal junction adenocarcinoma, renal cell carcinoma, and urothelial (transitional) cell carcinoma will be treated with INBRX-105 in combination with Pembrolizumab.
 Drug: INBRX-105 - PDL1x41BB antibody
The active ingredient of INBRX-105 is a recombinant, humanized, bispecific IgG antibody that targets the human programmed death-ligand 1 (PD-L1) receptor and the human 4-1BB receptor.

Drug: Pembrolizumab
Pembrolizumab 200 mg by intravenous (IV) infusion, given on Day 1 of each 21-day cycle.
Other Name: Keytruda
Experimental: Combination Expansion Cohort CPI Naive Non-small Cell Lung Cancer
CPI naive patients (PD-L1 IHC between 1 and 49%) will be treated with INBRX-105 in combination with Pembrolizumab.
 Drug: INBRX-105 - PDL1x41BB antibody
The active ingredient of INBRX-105 is a recombinant, humanized, bispecific IgG antibody that targets the human programmed death-ligand 1 (PD-L1) receptor and the human 4-1BB receptor.

Drug: Pembrolizumab
Pembrolizumab 200 mg by intravenous (IV) infusion, given on Day 1 of each 21-day cycle.
Other Name: Keytruda
Experimental: Combination Expansion Cohort CPI Naive HNSCC
CPI naive patients (PD-L1 IHC >50%) will be treated with INBRX-105 in combination with Pembrolizumab.
 Drug: INBRX-105 - PDL1x41BB antibody
The active ingredient of INBRX-105 is a recombinant, humanized, bispecific IgG antibody that targets the human programmed death-ligand 1 (PD-L1) receptor and the human 4-1BB receptor.


Outcome Measures
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Primary Outcome Measures :
  1. Frequency of adverse events of INBRX-105 [ Time Frame: Up to 2-3 years ]
    Adverse events will be assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0.

  2. Severity of adverse events of INBRX-105 [ Time Frame: Up to 2-3 years ]
    Severity of adverse events will be assessed and assigned by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0.

  3. Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of INBRX-105 [ Time Frame: Up to 2-3 years ]
    The MTD and/or RP2D of INBRX-105 will be determined.


Secondary Outcome Measures :
  1. Area under the serum concentration time curve (AUC) of INBRX-105 [ Time Frame: Up to 2-3 years ]
    Area under the serum concentration time curve (AUC) of INBRX-105 will be determined.

  2. Maximum observed serum concentration (Cmax) of INBRX-105 [ Time Frame: Up to 2-3 years ]
    Maximum observed serum concentration (Cmax) of INBRX-105 will be determined.

  3. Trough observed serum concentration (Ctrough) of INBRX-105 [ Time Frame: Up to 2-3 years ]
    Trough observed serum concentration (Cmax) of INBRX-105 will be determined.

  4. Time to Cmax (Tmax) of INBRX-105 [ Time Frame: Up to 2-3 years ]
    Time to Cmax (Tmax) of INBRX-105 will be determined.

  5. Immunogenicity of INBRX-105 [ Time Frame: Up to 2-3 years ]
    Frequency of anti-drug antibodies (ADA) against INBRX-105 will be determined.


Other Outcome Measures:
  1. Anti-tumor activity of INBRX-105 [ Time Frame: Up to 2-3 years ]
    Tumor response will be determined by immune Response Evaluation Criteria in Solid Tumors (iRECIST).


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:

  • Parts 1 and 3 (escalation cohorts; completed): Patients with locally advanced or metastatic non-resectable solid tumors, whose disease has progressed despite standard therapy and for whom no further standard therapy exists.
  • Part 2 (expansion cohorts): Patients with non-small cell lung cancer, cutaneous melanoma, head and neck squamous cell carcinoma or solid tumors amenable to paired biopsies, with locally advanced or metastatic, non-resectable disease, which has progressed despite standard therapy or for whom no standard or clinically acceptable therapy exists.
  • Part 4 relapsed or refractory to CPI cohorts: NSCLC, cutaneous melanoma, HNSCC, MSI/TMB-high or MMRd solid tumors
  • Part 4 CPI naive cohorts: locally advanced or metastatic, non-resectable NSCLC or HNSCC
  • Refractory or relapsed to anti-PD-1 or anti-PD-L1, and anti-CTLA4 if applicable (NOTE: For all tumor types with checkpoint inhibitor approvals) with exception of the treatment naive NSCLC cohort.
  • PD-L1 positivity by immunohistochemistry (IHC): Parts 1 and 3 (escalation cohorts) PD-L1 positivity is not required. Parts 2 and 4 (expansion cohorts): Combined Positive Score (CPS) or Tumor Proportion Score (TPS) above certain thresholds as defined per protocol.
  • Adequate hematologic, coagulation, hepatic and renal function as defined per protocol.
  • Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.

Exclusion Criteria:

  • Prior exposure to 4-1BB agonists.
  • Receipt of any investigational product or any approved anticancer drug(s) or biological product(s) within 4 weeks prior to the first dose of study drug. Exceptions: Hormone replacement therapy, testosterone, or oral contraceptives. NOTE: Previous exposure to anti-PD-L1 checkpoint inhibitor requires a minimum washout period of 24 weeks prior to the first dose of study drug.
  • Hematologic malignancies (e.g., ALL, AML, MDS, CLL, CML, NHL, Hodgkin lymphoma and multiple myeloma).
  • 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-105.
  • 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.
  • Grade ≥ 3 immune-related adverse events (irAEs) or irAE that lead to discontinuation of prior immunotherapy. Some exceptions as defined per protocol apply.
  • Active autoimmune disease or documented history of autoimmune disease that required systemic steroids or other immunosuppressive medications. Certain exceptions as defined in protocol apply.
  • Treatment with systemic immunosuppressive medications within 4 weeks prior to the first dose of study drug. Certain exceptions as defined in protocol apply.
  • History of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV). Exceptions as defined in protocol for expansion cohorts will apply.
  • History of hepatitis or cirrhosis (e.g., non-alcohol steatohepatitis, alcohol or drug-related, autoimmune, hepatitis B, or hepatitis C). Exceptions as defined in protocol for expansion cohorts will apply.
  • Active interstitial lung disease (ILD) or pneumonitis or a history of ILD or pneumonitis requiring treatment with steroids or other immunosuppressive medications.
  • 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.
  • Anti-infectious drug treatments (i.e., antibiotics) within 4 weeks prior to the first dose of study drug.
  • Prior organ allograft transplantations or allogeneic peripheral blood stem cell (PBSC) or bone marrow (BM) transplantation.
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT03809624


Contacts
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Contact: Amanda Sweeney 858-500-7833 clinicaltrials@inhibrx.com
Contact: Terri Boyea, PharmD clinicaltrials@inhibrx.com

Locations
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United States, Arizona
HonorHealth Research Institute Recruiting
Scottsdale, Arizona, United States, 85258
Contact: Joyce Schaffer    480-323-1791    jschaffner@honorhealth.com   
Principal Investigator: Tsai Frank, MD         
United States, California
City of Hope Recruiting
Duarte, California, United States, 91010
Contact: Shamili Thiagarajan    626-218-0979    sthiagarajan@coh.org   
Valkyrie Clinical Trials Recruiting
Los Angeles, California, United States, 90069
Contact: Myo Zaw    310-905-6791    myo.zaw@valkyrieclinicaltrials.com   
United States, Georgia
Emory University - Winship Cancer Institute Recruiting
Atlanta, Georgia, United States, 30322
Contact: Suzanne Scott    404-778-4083    suzanne.e.scott@emory.edu   
United States, Kentucky
Norton Cancer Center Recruiting
Louisville, Kentucky, United States, 40202
Contact: Jade Alexander, RN    502-629-2500 ext 19535    Jade.Alexander@nortonhealthcare.org   
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Park Jong Chul, MD       jpark73@mgh.harvard.edu   
Principal Investigator: Jong Chul Park, MD         
United States, Michigan
START Midwest Recruiting
Grand Rapids, Michigan, United States, 49546
Contact: Katie Robinson    616-389-1739    Katie.Robinson@startmidwest.com   
United States, Nebraska
Nebraska Cancer Specialists Recruiting
Omaha, Nebraska, United States, 68130
Contact: Josh Settlemire    531-329-3651    Jsettlemire@nebraskacancer.com   
United States, Oregon
Providence Cancer Institute Recruiting
Portland, Oregon, United States, 97213
Contact: Tara Foote, RN    503-215-7192    tara.foote@providence.org   
United States, Pennsylvania
Abramson Cancer Center - University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: James Phillips    215-662-7179    James.Phillips@pennmedicine.upenn.edu   
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Anna Lui    713-794-1751    ALui@mdanderson.org   
United States, Utah
START Mountain Region Recruiting
West Valley City, Utah, United States, 84119
Contact: Marianne Herndon    801-590-8520 ext 1515    marianne.herndon@startthecure.com   
United States, Virginia
Virginia Cancer Specialists Recruiting
Fairfax, Virginia, United States, 22031
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: NCT03809624    
Other Study ID Numbers: Ph 2 INBRX-105
First Posted: January 18, 2019    Key Record Dates
Last Update Posted: May 11, 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.:
41BB
Phase 2
Phase 2 Clinical Trial
Solid Tumors
Lung Cancer
Melanoma
Head and Neck Cancer
Stomach Cancer
Gastric Cancer
Kidney Cancer
 Renal cell carcinoma
Renal Cancer
Urothelial Carcinoma
PDL1
PD-L1
4-1BB
Pembrolizumab
Keytruda
Nasopharyngeal carcinoma
Oropharyngeal carcinoma
Additional relevant MeSH terms:
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Carcinoma
Melanoma
Adenocarcinoma
Carcinoma, Renal Cell
Nasopharyngeal Carcinoma
Carcinoma, Transitional Cell
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
 Nevi and Melanomas
Carcinoma, Squamous Cell
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Kidney Diseases
Urologic Diseases
Male Urogenital Diseases
Nasopharyngeal Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms