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Naptumomab Estafenatox (NAP) in Combination With Docetaxel Following Obinutuzumab Pretreatment in Subjects With Checkpoint Inhibitor Pretreated Advanced or Metastatic NSCLC (NT-NAP-102-1)

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ClinicalTrials.gov Identifier: NCT04880863
Recruitment Status : Recruiting
First Posted : May 11, 2021
Last Update Posted : October 21, 2021
Sponsor:
Collaborator:
Translational Drug Development
Information provided by (Responsible Party):
NeoTX Therapeutics Ltd.

Brief Summary:
Phase 2a Open-Label, Multicenter Trial of Naptumomab Estafenatox (NAP), on Days 1-4, in Combination with Docetaxel, on Day 5, Following Obinutuzumab Pretreatment, on Days -13 and -12. Treatment cycles will be 21 days in duration.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Drug: NAP (Naptumomab estafenatox) Drug: Docetaxel Drug: Obinutuzumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Subjects will receive obinutuzumab, 1,000 mg, administered by IV infusion on Days -13 and -12 of the first treatment cycle in order to reduce the titer of anti-drug antibodies to NAP. NAP will be administered in a daily dose of 10 μg/kg by IV bolus on Days 1 - 4 of each treatment cycle, followed by docetaxel, 75 mg/m2 on Day 5 of each treatment cycle. Treatment cycles will be 21 days in duration.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2a Open-Label, Multicenter Trial of Naptumomab Estafenatox (NAP) in Combination With Docetaxel Following Obinutuzumab Pretreatment in Subjects With Checkpoint Inhibitor Pretreated Advanced or Metastatic Non-Small Cell Lung Cancer
Actual Study Start Date : July 29, 2021
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : October 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: NAP in combination with docetaxel following obinutuzumab pretreatment
Subjects will receive obinutuzumab, 1,000 mg, administered by IV infusion on Days -13 and -12 of the first treatment cycle in order to reduce the titer of anti-drug antibodies to NAP. NAP will be administered in a daily dose of 10 μg/kg by IV bolus on Days 1 - 4 of each treatment cycle, followed by docetaxel, 75 mg/m2 on Day 5 of each treatment cycle.
Drug: NAP (Naptumomab estafenatox)
Naptumomab estafenatox (NAP; ABR-217620) is a recombinant fusion protein consisting of a chimeric staphylococcal enterotoxin A/E (SEA/SEE) superantigen with several additional substitutions that is linked to a Fab moiety recognizing a tumor-associated glycoprotein, 5T4. NAP is administered on Days 1-4 of each treatment cycle.
Other Names:
  • ABR-217620
  • Anyara

Drug: Docetaxel
Docetaxel is administered in combination with the study drug, NAP, on Day 5 of the treatment cycle.
Other Name: Taxotere

Drug: Obinutuzumab
Obinutuzumab is administered as pre-medication on Day -13 and -12 of the first treatment cycle.
Other Name: Gazyva




Primary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: From the first administration of obinutuzumab pretreatment to first CR or PR (estimated about 24 months) ]
    The proportion of subjects who achieve a best response of CR or PR per Response Evaluation in Solid Tumors (RECIST 1.1).


Secondary Outcome Measures :
  1. Disease Control Rate (DCR) [ Time Frame: From the first administration of obinutuzumab pretreatment till study completion (estimated about 24 months). ]
    The proportion of subjects who achieve a best response of CR, PR or SD per Response Evaluation in Solid Tumors (RECIST 1.1).

  2. Duration of Response (DOR) [ Time Frame: From first documentation of CR or PR (whichever occurs first) after the first administration of obinutuzumab pretreatment until death or progressive disease (PD) (estimated about 24 months). ]
  3. Progression-free survival (PFS) [ Time Frame: From the first administration of obinutuzumab pretreatment to the date of first documentation of disease progression, or death due to any cause, whichever occurs first (estimated about 24 months). ]
    PFS per Response Evaluation in Solid Tumors (RECIST 1.1)

  4. 6-month PFS rates [ Time Frame: From the first administration of obinutuzumab pretreatment to the date of first documentation of disease progression, or death due to any cause, whichever occurs first (up to 6 months). ]
    PFS per Response Evaluation in Solid Tumors (RECIST 1.1)

  5. 12-month PFS rates [ Time Frame: From the first administration of obinutuzumab pretreatment to the date of first documentation of disease progression, or death due to any cause, whichever occurs first (up to 12 months). ]
    PFS per Response Evaluation in Solid Tumors (RECIST 1.1)

  6. Overall Survival (OS) [ Time Frame: From the first administration of obinutuzumab pretreatment to death from any cause (estimated about 24 months). ]
  7. Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: From the first administration of obinutuzumab pretreatment till study completion (estimated about 24 months). ]
    Number of subjects with treatment-related adverse events as assessed by CTCAE v5.0

  8. NAP blood levels over time [ Time Frame: From the first administration of NAP till study completion (estimated about 24 months). ]
    NAP concentration

  9. Change From Baseline in the titer of anti-drug antibodies (ADAs) and human anti-mouse antibodies (HAMA) to NAP. [ Time Frame: From the first administration of NAP till study completion (estimated about 24 months). ]


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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:

  1. Subjects must be at least 18 years of age
  2. Subjects must have histologically and/or cytologically confirmed NSCLC
  3. Subjects must have incurable (advanced or metastatic) disease at the time of enrolment
  4. Subjects must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  5. Subjects must provide signed informed consent prior to any study specific procedures that are not part of standard medical care.
  6. Subjects must have measurable neoplastic disease based on the RECIST 1.1 criteria
  7. Subjects must have received as least 1 and no more than 2 prior systemic regimens for the treatment of advanced/metastatic NSCLC. Patients are required to have progressed following treatment with both platinum-based chemotherapy and an anti-PD-(L)1 antibody administered either sequentially or concurrently. A prior PD-1/PD-L1 inhibitor is, however, not required if there was prior exposure to targeted therapies for a driver mutation positive tumors (e.g. EGFR or ALK inhibitors).

Exclusion Criteria:

  1. Subjects with active infection requiring treatment within 3 days of C1D1.
  2. Subjects with other active neoplastic disease requiring concurrent anti-neoplastic treatment
  3. Subjects with known, suspected or documented parenchymal brain metastases unless treated with surgery and/or radiation, with the subject neurologically stable and off pharmacologic doses of systemic glucocorticoids; subjects with leptomeningeal metastases are not eligible. Patients should have completed brain radiation for at least 14 days and be off steroids per exclusion criteria 7.
  4. Active or previously documented autoimmune or inflammatory disorders such as, but not limited to rheumatoid arthritis, systemic lupus erythematosus, uveitis, ulcerative colitis, Crohn's syndrome, Wegener's syndrome, multiple sclerosis, myasthenia gravis, scleroderma and sarcoidosis. The following are exceptions to this criterion:

    • Vitiligo or psoriasis not requiring systemic treatment (within the last 2 years)
    • Subjects with endocrinopathies (e.g. following Hashimoto syndrome) stable on hormone replacement or do not require any therapy.
  5. History of primary immunodeficiency
  6. Subjects with a history or prior allogeneic organ transplant

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): NCT04880863


Contacts
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Contact: Jordan Jacobs, MBA 602-358-8376 jjacobs@td2inc.com
Contact: Tal Hetzroni Kedem, MSc 609 718 2305 ext 224

Locations
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United States, Alabama
NeoTX - 10307 Recruiting
Daphne, Alabama, United States, 36526
United States, Arizona
NeoTX - 10302 Recruiting
Scottsdale, Arizona, United States, 85258
NeoTX - 10303 Recruiting
Tucson, Arizona, United States, 85711
United States, Colorado
NeoTX - 10306 Recruiting
Lone Tree, Colorado, United States, 80124
United States, Minnesota
NeoTX - 10304 Recruiting
Minneapolis, Minnesota, United States, 55404
United States, Texas
NeoTX - 10308 Recruiting
Austin, Texas, United States, 78745
NeoTX - 10309 Recruiting
Dallas, Texas, United States, 75246
NeoTX - 10312 Recruiting
El Paso, Texas, United States, 79902
NeoTX - 10310 Recruiting
Tyler, Texas, United States, 75702
United States, Virginia
NeoTX - 10311 Recruiting
Fairfax, Virginia, United States, 22205
Sponsors and Collaborators
NeoTX Therapeutics Ltd.
Translational Drug Development
Investigators
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Study Director: Ilana Lorber, MD NeoTX Therapeutics Ltd.
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Responsible Party: NeoTX Therapeutics Ltd.
ClinicalTrials.gov Identifier: NCT04880863    
Other Study ID Numbers: NT-NAP-102-1
First Posted: May 11, 2021    Key Record Dates
Last Update Posted: October 21, 2021
Last Verified: October 2021
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 NeoTX Therapeutics Ltd.:
Advanced
Metastatic
Non small cell lung cancer
EGFR
ALK
Docetaxel
Naptumomab estafenatox
Obinutuzumab
NAP
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Docetaxel
Obinutuzumab
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological