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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
38
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.
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.
Obinutuzumab is administered as pre-medication on Day -13 and -12 of the first treatment cycle.
NeoTX - 10307
Daphne, Alabama, United States
NeoTX - 10302
Scottsdale, Arizona, United States
NeoTX - 10303
Tucson, Arizona, United States
NeoTX - 10306
Lone Tree, Colorado, United States
NeoTX - 10304
Minneapolis, Minnesota, United States
NeoTX - 10100
Morristown, New Jersey, United States
NeoTX - 10308
Austin, Texas, United States
NeoTX - 10309
Dallas, Texas, United States
NeoTX - 10312
El Paso, Texas, United States
NeoTX - 10310
Tyler, Texas, United States
...and 1 more locations
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
Time frame: From the first treatment to first CR or PR (estimated about 24 months)
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).
Time frame: From the first administration of treatment till study completion (estimated about 24 months).
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)
Time frame: estimated about 24 months.
Progression-free Survival (PFS)
PFS per Response Evaluation in Solid Tumors (iRECIST)
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).
Overall Survival (OS)
The time from first day of study drug treatment to death for any cause
Time frame: estimated about 24 months.
Treatment-Emergent Adverse Events (TEAEs)
Number of subjects with treatment emergent adverse events as assessed by CTCAE v5.0
Time frame: From the first administration of obinutuzumab pretreatment till study completion (estimated about 24 months).
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