AB-16B5 Combined With Docetaxel in Subjects With Metastatic Non-Small Cell Lung Cancer (EGIA-002)

Inclusion Criteria

• Subjects (male or non-pregnant female) must be ≥ 18 years of age on the day of signing the informed consent.
• Subjects with a histologically or cytologically confirmed diagnosis of (Stage III-IV) non-small cell lung cancer (NSCLC) and with at least one measurable lesion defined by RECIST 1.1.
• Subjects must have experienced a disease progression following treatment with an anti-PD1 or PD-L1 immune checkpoint antibody and a platinum-containing doublet treatment, administered simultaneously or sequentially.
• Subjects with a targetable driver mutation in EGFR or ALK gene will be allowed on trial after failing all available targeted therapies and having experienced a disease progression following treatment with an anti-PD1 or PD-L1 immune checkpoint antibody and a platinum-containing doublet treatment, administered simultaneously or sequentially.
• Subjects must have adequate organ and immune function
• Subjects must have a tumor lesion amenable for biopsies with no contraindication for biopsy.
• Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
• Subjects must have a life expectancy of at least 3 months.
• Subjects must have recovered from the toxic effects resulting from the most recent cancer treatment to Grade 1 or less. If the subjects underwent major surgery or received radiation therapy, they must have recovered from the complications and/or toxicity.
• Female subjects of childbearing potential must have a negative serum pregnancy test within 72 hours prior to the first dose of study treatment.
• Subjects (both male and female) of reproductive potential must be willing to practice highly effective methods of contraception throughout the study and for up to 90 days after the last dose of study medication. Abstinence is acceptable if this is the subject's usual lifestyle.
• Female subjects are not considered of childbearing potential if they have a history of surgical sterility or evidence of post-menopausal status defined as any of the following:
• ≥ 45 years of age and has not had menses for more than 2 years.
• Amenorrhoeic for less than 2 years without hysterectomy and oophorectomy and a follicle stimulating hormone (FSH) value in the postmenopausal range at screening.
• Post hysterectomy, oophorectomy or tubal ligation. Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or by ultrasound. Tubal ligation must be confirmed with medical records of the actual procedure.
• Subjects must understand and be able and willing and likely to fully comply with the study procedures, including scheduled follow-up, and restrictions.
• Subjects must have given written personally signed and dated informed consent to participate in the study in accordance with the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines, before completing any study related procedures.

Exclusion Criteria

• Subjects who have received prior therapy with AB-16B5.
• Subjects who have received prior therapy with docetaxel for the treatment of NSCLC.
• Subjects who are currently participating or has participated in a study of an investigational agent or using an investigational device within 21 days prior to the first dose of study treatment. The 21-day window should be calculated using the last dose of an antineoplastic investigational agent or last use of an investigational device with antineoplastic intent.
• Subjects who have received any anti-cancer treatment within 3 weeks or radiation therapy within 2 weeks prior to receiving the first dose of study treatment or who have not recovered from adverse events to Grade 1 or less. Subjects with alopecia are eligible to participate.
• Subjects who are expected to require any other form of systemic or localized antineoplastic therapy while on the trial. This includes maintenance therapy with another agent or radiation therapy.
• Subjects who are receiving a dose >