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Completed

NCT Number: NCT04880863

NAP in Combination With Docetaxel Following Obinutuzumab Pretreatment in Subjects With Checkpoint Inhibitor Pretreated Advanced or Metastatic NSCLC

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.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

NeoTX - 10307, Daphne, Alabama, United States

Loading trial locations.

About this study

Patients must have received at least 1 and no more than 2 prior systemic regimens for the treatment of advanced/metastatic NSCLC. Patients were required to have progressed following treatment with both platinum-based chemotherapy and an anti-PD-(L)1 antibody administered either sequentially or concurrently. Entry into this trial was restricted to patients with incurable disease, including those whose disease had relapsed within 6 months after chemoradiotherapy for Stage III disease. Patients were to have available archival or fresh tissue collected for the retrospective determination of tumoral 5T4 levels.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Main Inclusion Criteria:

  • Subjects must be at least 18 years of age
  • Subjects must have histologically and/or cytologically confirmed NSCLC
  • Subjects must have incurable (advanced or metastatic) disease at the time of enrolment
  • Subjects must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Subjects must provide signed informed consent prior to any study specific procedures that are not part of standard medical care.
  • Subjects must have measurable neoplastic disease based on the iRECIST criteria
  • 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:

  • Subjects with active infection requiring treatment within 3 days of C1D1.
  • Subjects with other active neoplastic disease requiring concurrent anti-neoplastic treatment
  • 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.
  • 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.
  • History of primary immunodeficiency
  • Subjects with a history or prior allogeneic organ transplant

Treatment and study plan

NAP (Naptumomab estafenatox)

Drug

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 are linked to a Fab moiety recognizing a tumor-associated glycoprotein, 5T4. NAP is administered at 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 is administered on Day 1.

Other names: ABR-217620, Anyara

docetaxel

Drug

Docetaxel is administered in combination with the study drug, NAP, on Day 5 of the treatment cycles 1-6. Starting cycle 7, Docetaxel is administered in combination with the study drug, NAP, on Day 2.

Other names: Taxotere

Obinutuzumab

Drug

Obinutuzumab is administered as pre-medication on Day -13 and -12 of the first treatment cycle.

Other names: Gazyva

Primary outcomes

  1. Objective Response Rate (ORR)

    Time frame: From the first treatment to first CR or PR (estimated about 24 months)

    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) and iRECIST for target lesions and assessed by CT scans or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

Secondary outcomes

  1. Disease Control Rate (DCR)

    Time frame: From the first administration of treatment 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).

  2. 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)

  3. Progression-free Survival (PFS)

    Time frame: From the first administration of treatment 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)

  4. Overall Survival (OS)

    Time frame: estimated about 24 months.

    The time from first day of study drug treatment to death for any cause

  5. 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 emergent adverse events as assessed by CTCAE v5.0

Sponsors and collaborators

Lead sponsor

NeoTX Therapeutics Ltd.

Industry

Collaborators

  • Translational Drug Development

Registry information

Official study 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

Acronym: NT-NAP-102-1

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
May 11, 2021
Registry last updated
Mar 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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