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Non-small Cell Lung CancerPhase 2NT-NAP-102-1NCT04880863

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

A Phase 2 study testing NAP (Naptumomab estafenatox), Docetaxel and Obinutuzumab in people with Non-small Cell Lung Cancer, run by NeoTX Therapeutics Ltd. at 11 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-small Cell Lung Cancer
What is being tested?
NAP (Naptumomab estafenatox), Docetaxel and Obinutuzumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
11 sitesUnited States
Study dates
26 Oct 2021to 30 Jan 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.
  1. History of primary immunodeficiency
  2. Subjects with a history or prior allogeneic organ transplant

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

United States11 sites

  • NeoTX - 10308

    Austin, Texas, 78745

  • NeoTX - 10309

    Dallas, Texas, 75246

  • NeoTX - 10307

    Daphne, Alabama, 36526

  • NeoTX - 10312

    El Paso, Texas, 79902

  • NeoTX - 10311

    Fairfax, Virginia, 22205

  • NeoTX - 10306

    Lone Tree, Colorado, 80124

  • NeoTX - 10304

    Minneapolis, Minnesota, 55404

  • NeoTX - 10100

    Morristown, New Jersey, 07962

  • NeoTX - 10302

    Scottsdale, Arizona, 85258

  • NeoTX - 10303

    Tucson, Arizona, 85711

  • NeoTX - 10310

    Tyler, Texas, 75702

Other trials in United States

About this study

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

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.

Read the detailed description

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.

Being tested
NAP (Naptumomab estafenatox), Docetaxel, Obinutuzumab
Keywords
Advanced, Metastatic, Non small cell lung cancer, EGFR, ALK, Docetaxel, Naptumomab estafenatox, Obinutuzumab, NAP
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NAP (Naptumomab estafenatox)Drug

    Also called ABR-217620, Anyara

    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.

  • DocetaxelDrug

    Also called Taxotere

    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.

  • ObinutuzumabDrug

    Also called Gazyva

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

Study groups in NCT04880863
Study groupRoleWhat they receive
NAP in combination with docetaxel following obinutuzumab pretreatmentExperimentalSubjects 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 is administered by IV bolus on Days 1 - 4 of treatment cycles 1-6, followed by docetaxel on Day 5. Treatment cycles with the combination NAP/docetaxel are of 21 days in duration. Starting cycle 7, NAP at a higher dose is 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 are of 28 days of duration.
Receives: Drug: NAP (Naptumomab estafenatox); Drug: Docetaxel; Drug: Obinutuzumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (ORR)

    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

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

Secondary outcomes (5)

  1. Disease Control Rate (DCR)

    The proportion of subjects who achieve a best response of CR, PR or SD per Response Evaluation in Solid Tumors (iRECIST).

    Measured: From the first administration of treatment till study completion (estimated about 24 months).

  2. Duration of Response (DOR)

    Duration from first documentation of CR or PR (whichever occurs first) after the first administration of obinutuzumab pretreatment until death or progressive disease (PD)

    Measured: estimated about 24 months.

  3. Progression-free Survival (PFS)

    PFS per Response Evaluation in Solid Tumors (iRECIST)

    Measured: 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).

  4. Overall Survival (OS)

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

    Measured: estimated about 24 months.

  5. Treatment-Emergent Adverse Events (TEAEs)

    Number of subjects with treatment emergent adverse events as assessed by CTCAE v5.0

    Measured: From the first administration of obinutuzumab pretreatment till study completion (estimated about 24 months).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2021
  2. Study start26 Oct 2021
  3. Primary completion30 Jan 2024
  4. Study completion30 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Subjects 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 is administered by IV bolus on Days 1 - 4 of treatment cycles 1-6, followed by docetaxel on Day 5. Treatment cycles with the combination NAP/docetaxel are of 21 days in duration. Starting cycle 7, NAP at a higher dose is 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 are of 28 days of duration.
Masking
None (open label)
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04880863
Sponsor's protocol ID
NT-NAP-102-1
Acronym
NT-NAP-102-1
Status last verified
Nov 2024
First submitted
3 May 2021
Last updated
3 Mar 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing NAP (Naptumomab estafenatox), Docetaxel and Obinutuzumab in people with Non-small Cell Lung Cancer, run by NeoTX Therapeutics Ltd. at 11 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: From the first treatment to first CR or PR (estimated about 24 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04880863.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2025.

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