A Phase 2 interventional study of NAP (Naptumomab estafenatox) and Docetaxel in Non-small Cell Lung Cancer, sponsored by NeoTX Therapeutics Ltd.. Completed at 11 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-03.
Sponsored by NeoTX Therapeutics Ltd. · Phase 2, Interventional, and Treatment
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.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,558 are open to participants now.
This study's enrollment of 38 is below the median of 60 across 5,296 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →NeoTX Therapeutics Ltd. is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Main Inclusion Criteria:
Main Exclusion Criteria:
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:
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
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
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
Obinutuzumab is administered as pre-medication on Day -13 and -12 of the first treatment cycle.
Also known as: Gazyva
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).
| Milestone | NAP in Combination With Docetaxel Following Obinutuzumab Pretreatment |
|---|---|
| Started | 38 |
| Completed | 0 |
| Not completed | 38 |
| Withdrew: Adverse event | 1 |
| Withdrew: Patient decision | 2 |
| Withdrew: Confirmed disease progression | 15 |
| Withdrew: Death | 3 |
| Withdrew: Physician decision | 4 |
| Withdrew: Unconfirmed disease progression | 4 |
| Withdrew: Withdrawal by subject | 2 |
| Withdrew: Study discontinuation by the sponsor | 4 |
| Withdrew: Progression disease identified by lumbar puncture | 1 |
| Withdrew: Not received study drug nap | 2 |
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
| percentage of responders | NAP in Combination With Docetaxel Following Obinutuzumab Pretreatment |
|---|---|
| Objective Response Rate (ORR) | 15.6 (5.3 to 32.8) |
The proportion of subjects who achieve a best response of CR, PR or SD per Response Evaluation in Solid Tumors (iRECIST).
| percentage of patients with SD, PR, CR | NAP in Combination With Docetaxel Following Obinutuzumab Pretreatment |
|---|---|
| Disease Control Rate (DCR) | 71.9 (53.3 to 86.3) |
Duration from first documentation of CR or PR (whichever occurs first) after the first administration of obinutuzumab pretreatment until death or progressive disease (PD)
| months | NAP in Combination With Docetaxel Following Obinutuzumab Pretreatment |
|---|---|
| Duration of Response (DOR) | 12.2 (1.6 to 17.7) |
PFS per Response Evaluation in Solid Tumors (iRECIST)
| months | NAP in Combination With Docetaxel Following Obinutuzumab Pretreatment |
|---|---|
| Progression-free Survival (PFS) | 8.8 (6.1 to 15.2) |
The time from first day of study drug treatment to death for any cause
| months | NAP in Combination With Docetaxel Following Obinutuzumab Pretreatment |
|---|---|
| Overall Survival (OS) | 8.8 (6.4 to 11.7) |
Number of subjects with treatment emergent adverse events as assessed by CTCAE v5.0
| participants | NAP in Combination With Docetaxel Following Obinutuzumab Pretreatment |
|---|---|
| TEAE Grade 1 or 2 | 37 |
| TEAEs Grade ≥3 | 34 |
| TEAE Related to Docetaxel Grade 1 or 2 | 28 |
| TEAE Related to Docetaxel Grade ≥ 3 | 27 |
| TEAE Related to Obinutuzumab Grade 1 or 2 | 18 |
| TEAE Related to Obinutuzumab Grade ≥ 3 | 6 |
| TEAE Related to NAP Grade 1 or 2 | 33 |
| TEAE Related to NAP Grade ≥ 3 | 22 |
| TEAE Related to NAP when given as a single agent Grade 1 or 2 | 4 |
| TEAE Related to NAP when given as a single agent Grade ≥ 3 | 3 |
Collected over Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| NAP in Combination With Docetaxel Following Obinutuzumab Pretreatment | 6/38 (15.8%) | 16/38 (42.1%) | 38/38 (100%) |
| Event | NAP in Combination With Docetaxel Following Obinutuzumab Pretreatment |
|---|---|
| PneumoniaInfections and infestations | 4/38 |
| Febrile neutropeniaBlood and lymphatic system disorders | 2/38 |
| PainGeneral disorders | 2/38 |
| Neutrophil count decreasedInvestigations | 2/38 |
| HypotensionVascular disorders | 2/38 |
| COVID-19Infections and infestations | 2/38 |
| SepsisInfections and infestations | 2/38 |
| Abdominal painGastrointestinal disorders | 1/38 |
| DiarrhoeaGastrointestinal disorders | 1/38 |
| NauseaGastrointestinal disorders | 1/38 |
| Event | NAP in Combination With Docetaxel Following Obinutuzumab Pretreatment |
|---|---|
| FatigueGeneral disorders | 24/38 |
| ChillsGeneral disorders | 22/38 |
| Neutrophil count decreasedInvestigations | 21/38 |
| NauseaGastrointestinal disorders | 16/38 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 15/38 |
| HypotensionVascular disorders | 13/38 |
| DiarrhoeaGastrointestinal disorders | 12/38 |
| PyrexiaGeneral disorders | 12/38 |
| AnaemiaBlood and lymphatic system disorders | 11/38 |
| VomitingGastrointestinal disorders | 11/38 |
A single arm trial
| Age, Continuous(years) | NAP in Combination With Docetaxel Following Obinutuzumab Pretreatment |
|---|---|
| Median | 66 (33 to 85) |
| Sex: Female, Male(Participants) | NAP in Combination With Docetaxel Following Obinutuzumab Pretreatment |
|---|---|
| Female | 17 |
| Male | 21 |
| Ethnicity (NIH/OMB)(Participants) | NAP in Combination With Docetaxel Following Obinutuzumab Pretreatment |
|---|---|
| Hispanic or Latino | 2 |
| Not Hispanic or Latino | 33 |
| Unknown or Not Reported | 3 |
| Race (NIH/OMB)(Participants) | NAP in Combination With Docetaxel Following Obinutuzumab Pretreatment |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 33 |
| More than one race | 0 |
| Unknown or Not Reported | 3 |
| Region of Enrollment(Participants) | NAP in Combination With Docetaxel Following Obinutuzumab Pretreatment |
|---|---|
| United States | 38 |
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NeoTX Therapeutics Ltd.