search
Back to results

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

Primary Purpose

Non-small Cell Lung Cancer

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
NAP (Naptumomab estafenatox)
Docetaxel
Obinutuzumab
Sponsored by
NeoTX Therapeutics Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring Advanced, Metastatic, Non small cell lung cancer, EGFR, ALK, Docetaxel, Naptumomab estafenatox, Obinutuzumab, NAP

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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

Sites / Locations

  • NeoTX - 10307
  • NeoTX - 10302
  • NeoTX - 10303
  • NeoTX - 10306
  • NeoTX - 10304
  • NeoTX - 10100
  • NeoTX - 10308
  • NeoTX - 10309
  • NeoTX - 10312
  • NeoTX - 10310
  • NeoTX - 10311

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NAP in combination with docetaxel following obinutuzumab pretreatment

Arm 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 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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).
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)
Progression-free survival (PFS)
PFS per Response Evaluation in Solid Tumors (iRECIST)
6-month PFS rates
PFS per Response Evaluation in Solid Tumors (iRECIST)
12-month PFS rates
PFS per Response Evaluation in Solid Tumors (iRECIST)
Overall Survival (OS)
The time from first day of study drug treatment (obinutuzumab) to death for any cause
Treatment-Emergent Adverse Events (TEAEs)
Number of subjects with treatment-related adverse events as assessed by CTCAE v5.0
NAP blood levels over time
NAP concentration
NAP immunogenicity
Change From Baseline in the titer of anti-drug antibodies (ADAs) and human anti-mouse antibodies (HAMA) to NAP.

Full Information

First Posted
May 3, 2021
Last Updated
August 14, 2023
Sponsor
NeoTX Therapeutics Ltd.
Collaborators
Translational Drug Development
search

1. Study Identification

Unique Protocol Identification Number
NCT04880863
Brief Title
Naptumomab Estafenatox (NAP) in Combination With Docetaxel Following Obinutuzumab Pretreatment in Subjects With Checkpoint Inhibitor Pretreated Advanced or Metastatic NSCLC
Acronym
NT-NAP-102-1
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 26, 2021 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NeoTX Therapeutics Ltd.
Collaborators
Translational Drug Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
Keywords
Advanced, Metastatic, Non small cell lung cancer, EGFR, ALK, Docetaxel, Naptumomab estafenatox, Obinutuzumab, NAP

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
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 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 will be 21 days in duration. Starting cycle 7, NAP at a higher dose 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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NAP in combination with docetaxel following obinutuzumab pretreatment
Arm Type
Experimental
Arm 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 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.
Intervention Type
Drug
Intervention Name(s)
NAP (Naptumomab estafenatox)
Other Intervention Name(s)
ABR-217620, Anyara
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Other Intervention Name(s)
Taxotere
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Obinutuzumab
Other Intervention Name(s)
Gazyva
Intervention Description
Obinutuzumab is administered as pre-medication on Day -13 and -12 of the first treatment cycle.
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
The proportion of subjects who achieve a best response of CR or PR per Response Evaluation in Solid Tumors (iRECIST).
Time Frame
From the first administration of obinutuzumab pretreatment to first CR or PR (estimated about 24 months)
Secondary Outcome Measure Information:
Title
Disease Control Rate (DCR)
Description
The proportion of subjects who achieve a best response of CR, PR or SD per Response Evaluation in Solid Tumors (iRECIST).
Time Frame
From the first administration of obinutuzumab pretreatment till study completion (estimated about 24 months).
Title
Duration of Response (DOR)
Description
Duration from first documentation of CR or PR (whichever occurs first) after the first administration of obinutuzumab pretreatment until death or progressive disease (PD)
Time Frame
(estimated about 24 months).
Title
Progression-free survival (PFS)
Description
PFS per Response Evaluation in Solid Tumors (iRECIST)
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).
Title
6-month PFS rates
Description
PFS per Response Evaluation in Solid Tumors (iRECIST)
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).
Title
12-month PFS rates
Description
PFS per Response Evaluation in Solid Tumors (iRECIST)
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).
Title
Overall Survival (OS)
Description
The time from first day of study drug treatment (obinutuzumab) to death for any cause
Time Frame
(estimated about 24 months).
Title
Treatment-Emergent Adverse Events (TEAEs)
Description
Number of subjects with treatment-related adverse events as assessed by CTCAE v5.0
Time Frame
From the first administration of obinutuzumab pretreatment till study completion (estimated about 24 months).
Title
NAP blood levels over time
Description
NAP concentration
Time Frame
From the first administration of NAP till study completion (estimated about 24 months).
Title
NAP immunogenicity
Description
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).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ilana Lorber, MD
Organizational Affiliation
NeoTX Therapeutics Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
NeoTX - 10307
City
Daphne
State/Province
Alabama
ZIP/Postal Code
36526
Country
United States
Facility Name
NeoTX - 10302
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Facility Name
NeoTX - 10303
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85711
Country
United States
Facility Name
NeoTX - 10306
City
Lone Tree
State/Province
Colorado
ZIP/Postal Code
80124
Country
United States
Facility Name
NeoTX - 10304
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
NeoTX - 10100
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07962
Country
United States
Facility Name
NeoTX - 10308
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
NeoTX - 10309
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
NeoTX - 10312
City
El Paso
State/Province
Texas
ZIP/Postal Code
79902
Country
United States
Facility Name
NeoTX - 10310
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
Facility Name
NeoTX - 10311
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22205
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs