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

February 21, 2024 updated by: NeoTX Therapeutics Ltd.

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

Phase 2a Open-Label, Multicenter Trial of Naptumomab Estafenatox (NAP), following Obinutuzumab Pretreatment, on Days -13 and -12. NAP will be administered on Days 1-4 of treatment cycles 1-6, followed by docetaxel on Day 5. Starting cycle 7, NAP at a higher dose will be administered on Day 1 only and docetaxel on Day 2, in 21 days treatment cycles. When NAP is administered as monotherapy and not earlier than cycle 7, NAP will be administered on Day 1 only and cycles will be of 28 days treatment cycle.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Tal Hetzroni Kedem, MSc
  • Phone Number: 224 609 718 2305

Study Locations

  • United States
    • Alabama
      • Daphne, Alabama, United States, 36526
        • NeoTX - 10307
    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • NeoTX - 10302
      • Tucson, Arizona, United States, 85711
        • NeoTX - 10303
    • Colorado
      • Lone Tree, Colorado, United States, 80124
        • NeoTX - 10306
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • NeoTX - 10304
    • New Jersey
      • Morristown, New Jersey, United States, 07962
        • NeoTX - 10100
    • Texas
      • Austin, Texas, United States, 78745
        • NeoTX - 10308
      • Dallas, Texas, United States, 75246
        • NeoTX - 10309
      • El Paso, Texas, United States, 79902
        • NeoTX - 10312
      • Tyler, Texas, United States, 75702
        • NeoTX - 10310
    • Virginia
      • Fairfax, Virginia, United States, 22205
        • NeoTX - 10311

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Main 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 iRECIST 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).

Main 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.

  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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 treatment cycles 1-6, followed by docetaxel, 75 mg/m2 on Day 5. Treatment cycles with the combination NAP/docetaxel will be 21 days in duration. Starting cycle 7, NAP at a higher dose of 15 μg/kg will be administered on Day 1 and docetaxel on Day 2, in 21 days treatment cycles. Once NAP is given as monotherapy and not earlier than C7, cycles will be of 28 days of duration.
Drug: Obinutuzumab
Obinutuzumab is administered as pre-medication on Day -13 and -12 of the first treatment cycle.
Other Names:
  • Gazyva
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 will be administered in a dose of 10 μg/kg/day by IV bolus on Days 1 - 4 of treatment cycles 1-6. Starting cycle 7, NAP at a higher dose of 15 μg/kg will be administered on Day 1.
Other Names:
  • ABR-217620
  • Anyara
Drug: Docetaxel
Docetaxel is administered in combination with the study drug, NAP, on Day 5 of the treatment cycles 1-6. Starting cycle 7, Docetaxel will be administered in combination with the study drug, NAP, on Day 2.
Other Names:
  • Taxotere

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 (iRECIST).
From the first administration of obinutuzumab pretreatment to first CR or PR (estimated about 24 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 (iRECIST).
From the first administration of obinutuzumab pretreatment till study completion (estimated about 24 months).
Duration of Response (DOR)
Time Frame: (estimated about 24 months).
Duration 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).
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 (iRECIST)
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).
Overall Survival (OS)
Time Frame: (estimated about 24 months).
The time from first day of study drug treatment (obinutuzumab) to death for any cause
(estimated about 24 months).
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
From the first administration of obinutuzumab pretreatment till study completion (estimated about 24 months).
NAP blood levels over time
Time Frame: From the first administration of NAP till study completion (estimated about 24 months).
NAP concentration
From the first administration of NAP till study completion (estimated about 24 months).
NAP immunogenicity
Time Frame: From the first administration of NAP till study completion (estimated about 24 months).
Change From Baseline in the titer of anti-drug antibodies (ADAs) to NAP.
From the first administration of NAP till study completion (estimated about 24 months).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NeoTX Therapeutics Ltd.

Collaborators

Translational Drug Development

Investigators

  • Study Director: Ilana Lorber, MD, NeoTX Therapeutics Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 26, 2021

Primary Completion (Actual)

January 30, 2024

Study Completion (Actual)

January 30, 2024

Study Registration Dates

First Submitted

May 3, 2021

First Submitted That Met QC Criteria

May 5, 2021

First Posted (Actual)

May 11, 2021

Study Record Updates

Last Update Posted (Estimated)

February 22, 2024

Last Update Submitted That Met QC Criteria

February 21, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NT-NAP-102-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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