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

NCT04880863 | Completed Phase 2 Results FDA Drug

• 1 other identifier: NT-NAP-102-1
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 11

Brief 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. 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.

Conditions

Non-small Cell Lung Cancer

Keywords

Advanced; Metastatic; Non small cell lung cancer; EGFR; ALK; Docetaxel; Naptumomab estafenatox; Obinutuzumab; NAP

Outcome Measures

Primary Outcomes (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

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

Secondary Outcomes (5)

• Disease Control Rate (DCR)

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

• Duration of Response (DOR)

  estimated about 24 months.

• Progression-free Survival (PFS)

  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).

• Overall Survival (OS)

  estimated about 24 months.

• Treatment-Emergent Adverse Events (TEAEs)

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

Study Arms (1)

NAP in combination with docetaxel following obinutuzumab pretreatment

EXPERIMENTAL

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.

Drug: NAP (Naptumomab estafenatox); Drug: Docetaxel; Drug: Obinutuzumab

Interventions

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.

Also known as: ABR-217620, Anyara

NAP in combination with docetaxel following obinutuzumab pretreatment

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.

Also known as: Taxotere

NAP in combination with docetaxel following obinutuzumab pretreatment

Obinutuzumab DRUG

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

Also known as: Gazyva

NAP in combination with docetaxel following obinutuzumab pretreatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• NeoTX Therapeutics Ltd.: lead
• Translational Drug Development: collaborator

Study Sites (11)

NeoTX - 10307

Daphne, Alabama, 36526, United States

Location

NeoTX - 10302

Scottsdale, Arizona, 85258, United States

Location

NeoTX - 10303

Tucson, Arizona, 85711, United States

Location

NeoTX - 10306

Lone Tree, Colorado, 80124, United States

Location

NeoTX - 10304

Minneapolis, Minnesota, 55404, United States

Location

NeoTX - 10100

Morristown, New Jersey, 07962, United States

Location

NeoTX - 10308

Austin, Texas, 78745, United States

Location

NeoTX - 10309

Dallas, Texas, 75246, United States

Location

NeoTX - 10312

El Paso, Texas, 79902, United States

Location

NeoTX - 10310

Tyler, Texas, 75702, United States

Location

NeoTX - 10311

Fairfax, Virginia, 22205, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Neoplasm Metastasis

Interventions

naptumomab estafenatox; Docetaxel; obinutuzumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Results Point of Contact

• Title: Dr. Ilana Lorber, VP of Clinical Operations
• Organization: NeoTX Therapeutics Ltd.

ilanal@neotx.com

+972-3-912-5853

Study Officials

• Ilana Lorber, MD

  NeoTX Therapeutics Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 3, 2021
• First Posted: May 11, 2021
• Study Start: October 26, 2021
• Primary Completion: January 30, 2024
• Study Completion: January 30, 2024
• Last Updated: March 3, 2025
• Results First Posted: March 3, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (11)