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

• Status: Recruiting
• Trial end date: 2023-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Phase 2a Open-Label, Multicenter Trial of Naptumomab Estafenatox (NAP), on Days 1-4, in Combination with Docetaxel, on Day 5, Following Obinutuzumab Pretreatment, on Days -13 and -12. Treatment cycles will be 21 days in duration.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NeoTX Therapeutics Ltd.
• Collaborator: Translational Drug Development
• Treatments: Docetaxel; Obinutuzumab

Criteria

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 RECIST 1.1 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).

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