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Trial record 2 of 2 for:    INBRX 101

A Study of ES101 (PD-L1x4-1BB Bispecific Antibody) in Patients With Advanced Malignant Thoracic Tumors

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ClinicalTrials.gov Identifier: NCT04841538
Recruitment Status : Not yet recruiting
First Posted : April 12, 2021
Last Update Posted : July 16, 2021
Sponsor:
Information provided by (Responsible Party):
Elpiscience Biopharma, Ltd.

Brief Summary:
The purpose of this study is to evaluate the safety, RP2D and PK/pharmacodynamic profile of ES101 monotherapy in patients with advanced NSCLC and to further evaluate the antitumor efficacy of ES101 in advanced malignant thoracic tumors, including NSCLC and SCLC.

Condition or disease Intervention/treatment Phase
Thoracic Tumors Non-small Cell Lung Cancer Small Cell Lung Cancer Drug: ES101 Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 276 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Multicenter, Multicohort Phase 1b/2 Clinical Trial of ES101 in Patients With Advanced Malignant Thoracic Tumors
Estimated Study Start Date : July 31, 2021
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : May 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cohort 1
ES101 is administered via intravenous infusion, 0.3mg/kg,once every 14 days, every 28 days as a treatment cycle.
Drug: ES101
The active ingredient of ES101 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: Cohort 2
ES101 is administered via intravenous infusion, 1mg/kg,once every 14 days, every 28 days as a treatment cycle.
Drug: ES101
The active ingredient of ES101 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: Cohort A1
ES101 is administered via intravenous infusion, RP2D (to be determined),once every 14 days, every 28 days as a treatment cycle.
Drug: ES101
The active ingredient of ES101 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: Cohort A2
ES101 is administered via intravenous infusion, RP2D (to be determined),once every 14 days, every 28 days as a treatment cycle.
Drug: ES101
The active ingredient of ES101 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: Cohort B
ES101 is administered via intravenous infusion, RP2D (to be determined),once every 14 days, every 28 days as a treatment cycle.
Drug: ES101
The active ingredient of ES101 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: Cohort C
ES101 is administered via intravenous infusion, RP2D (to be determined),once every 14 days, every 28 days as a treatment cycle.
Drug: ES101
The active ingredient of ES101 is a recombinant, humanized, bispecific IgG antibody that targets the human programmed death-ligand 1 (PD-L1) receptor and the human 4-1BB receptor.




Primary Outcome Measures :
  1. Phase 1b: Frequency and severity of adverse events of ES101 [ Time Frame: 1-2 years ]
    Adverse events will be assessed and assigned by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0.

  2. Phase 1b: Recommended Phase 2 Dose (RP2D) of of ES101 [ Time Frame: 6 months ]
    RP2D of ES101 will be determined.

  3. Phase 2: Objective response rate (ORR) [ Time Frame: 2-3 years ]
    Tumor response will be determined by the revised Response Evaluation Criteria in Solid Tumors version 1.1 (RECISTv1.1).


Secondary Outcome Measures :
  1. Anti-tumor activity of ES101 [ Time Frame: 2-4 years ]
    Tumor response will be determined by the revised Response Evaluation Criteria in Solid Tumors version 1.1 (RECISTv1.1).

  2. PK profile of ES101 [ Time Frame: 2-4 years ]
    Assess the relationship between ES101 exposure and efficacy/adverse events.

  3. Immunogenicity of ES101 [ Time Frame: 2-4 years ]
    Frequency of anti-drug antibodies (ADA) against ES101 will be determined.

  4. Pharmacodynamic markers [ Time Frame: 2-4 years ]
    Assess PD-L1 receptor occupancy and cytokines

  5. PD-L1 expression [ Time Frame: 2-4 years ]
    Assess PD-L1 expression status of tumor tissues



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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:

  • Ability to understand and the willingness to sign a written informed consent form.
  • Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.
  • At least one measurable lesion is required (RECIST v1.1)
  • Phase 1b: Subjects with pathologically or cytologically confirmed recurrent or metastatic NSCLC without known EGFR mutation and ALK and ROS1 gene rearrangements.
  • Phase II: Subjects with pathologically or cytologically confirmed recurrent or metastatic malignant thoracic tumours who have received 1-2 lines of systemic anti-tumour therapy, including platinum regimens, and have failed, including at least 2 cycles of chemotherapy.

Exclusion Criteria:

  • Prior exposure to 4-1BB agonists.
  • Receipt of any anticancer investigational product or any approved drug(s) or biological products (except hormone-replacement therapy, testosterone or oral contraceptives) within 4 weeks prior to the first dose of study drug. Previous exposure to oral fluorouracils or small molecular targeted drugs require a minimum washout period of 2 weeks or 5 half-lives prior to the first dose of study drug (whichever is longer). Previous exposure to mitomycin C or nitrosourea requires a minimum washout period of 6 weeks prior to the first dose of study drug.
  • Receipt of PD-L1 therapy within 24 weeks prior to the first dose of study drug.
  • Known allergies to CHO-produced antibodies, which in the opinion of the Investigator suggests an increased potential for an adverse hypersensitivity to ES101.
  • Grade ≥ 3 immune-related adverse events (irAEs) or irAE that lead to discontinuation of prior immunotherapy. Some exceptions as defined per protocol apply.
  • Subject has not recovered from all AEs of previous anticancer therapies to baseline or ≤ Grade 1 per CTCAE v5.0 before teh first dose of study drug. Certain exceptions as defined in 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.
  • Active interstitial lung disease (ILD) or pneumonitis or a history of ILD or pneumonitis requiring treatment with steroids or other immunosuppressive medications.
  • Systemic anti-infectious drug treatments within 4 weeks prior to the first dose of study drug.
  • Pregnant or nursing females.

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): NCT04841538


Contacts
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Contact: He Yafeng 86 021-50651310 clinical-operation@elpiscience.com

Sponsors and Collaborators
Elpiscience Biopharma, Ltd.
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Responsible Party: Elpiscience Biopharma, Ltd.
ClinicalTrials.gov Identifier: NCT04841538    
Other Study ID Numbers: ES101-2001
First Posted: April 12, 2021    Key Record Dates
Last Update Posted: July 16, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Elpiscience Biopharma, Ltd.:
ES101
INBRX-105
PD-L1
4-1BB
PD-L1×4-1BB
PDL1
41BB
Thoracic Tumor
Additional relevant MeSH terms:
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Lung Neoplasms
Small Cell Lung Carcinoma
Thoracic Neoplasms
Neoplasms
Respiratory Tract Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms