A Phase 1 Study Evaluating the Safety, Tolerability and Efficacy of AMG 119 in Subjects With RR SCLC

This is a phase 1, first-in-human study to evaluate the safety and tolerability of AMG 119,
an investigational, Chimeric Antigen Receptor T cell therapy targeting delta-like protein 3
(DLL3) in subjects with relapsed/refractory small cell lung cancer who progressed after at
least 1 platinum based chemotherapy regimen.

Inclusion Criteria:

- Subject has provided informed consent prior to initiation of any study-specific
activities/procedures;

- Age ≥ 18 years old at the time of signing the informed consent

- Histologically confirmed Small Cell Lung Cancer (SCLC) with radiographically
documented disease progression or recurrence after at least one platinum-based
regimen:

- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

- At least 2 measurable lesions as defined per modified RECIST 1.1 by CT or MRI
performed after the last line of anti-cancer therapy within 28 days of enrollment

- Subjects with treated brain metastases are eligible provided they meet the following
criteria:

- - Definitive therapy was completed at least 2 weeks prior to enrollment.

- - No evidence of radiographic CNS progression or CNS disease following definitive
therapy and by the time of study screening. Patients manifesting progression in
lesions previously treated with stereotactic radiosurgery may still be eligible if
pseudoprogression can be demonstrated by appropriate means and after discussion with
the medical monitor.

- - Any CNS disease is asymptomatic, any neurologic symptoms due to CNS disease have
returned to baseline or are deemed irreversible, the patient is off steroids for at
least 7 days (physiologic doses of steroids are permitted), and the patient is off or
on stable doses of anti-epileptic drugs for malignant CNS disease.

- Adequate organ function

- Other inclusion criteria may apply

Exclusion Criteria:

- History of other malignancy within the past 2 years prior to enrollment except:
Malignancy (other than in situ) treated with curative intent and with no known active
disease present for ≥ 2 years before enrollment and felt to be at low risk for
recurrence by the treating physician; Adequately treated non-melanoma skin cancer or
lentigo maligna without evidence of disease; Adequately treated in situ cancer without
evidence of disease; Prostatic intraepithelial neoplasia without evidence of prostate
cancer; Adequately treated urothelial papillary noninvasive carcinoma.

- History of organ transplant.

- Major surgery within 28 days of enrollment.

- Myocardial infarction and/or symptomatic congestive heart failure (New York Heart
Association > class II) within 12 months of enrollment.

- History of arterial thrombosis (eg, stroke or transient ischemic attack) within 12
months of enrollment.

- Untreated or symptomatic brain metastases and leptomeningeal disease

- Presence of fungal, bacterial, viral, or other infection requiring IV antimicrobials
for management within 7 days of enrollment. Note: Simple UTI and uncomplicated
bacterial pharyngitis are permitted if responding to active treatment and after
consultation with sponsor.

- Subject has known sensitivity and immediate hypersensitivity to any components of AMG
119 or conditioning regimen (cyclophosphamide and fludarabine).

- Evidence of a bleeding diathesis.

- Systemic corticosteroid therapy within 7 days before enrollment. Note: Topical and
inhaled corticosteroids in standard doses and physiologic replacement for subjects
with adrenal insufficiency are allowed. ≥ 5 mg/day of prednisone or equivalent doses
of other corticosteroids are not allowed.

- Prior anti-cancer therapy as specified below: At least 28 days from enrollment must
have elapsed from any prior systemic inhibitory/stimulatory immune checkpoint molecule
therapy (eg, ipilimumab, nivolumab, pembrolizumab, atezolizumab, OX40 agonists, 4-1BB
agonists, etc). Note: Patients who experienced immune -related pneumonitis, pituitary
or thyroid dysfunction, or pancreatitis while on treatment with immune-oncology agents
will be excluded; Other anti-cancer therapy (chemotherapy, antibody therapy, molecular
targeted therapy, or investigational agent) within 14 days prior to enrollment;
Radiation therapy completed within 14 days prior to enrollment; Prior CAR T therapy or
other genetically modified T cell therapy.

- Primary immunodeficiency

- History of autoimmune disease resulting in end organ injury or requiring systemic
immunosuppression/systemic disease modifying agents within the last 2 years prior to
enrollment

- Unresolved toxicities from prior anti-tumor therapy (defined as not having resolved to
Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 grade 1, or to
levels dictated in the eligibility criteria) with the exception of alopecia or
toxicities from prior anti-tumor therapy that are considered irreversible [defined as
having been present and stable for > 28 days] which may be allowed if they are not
otherwise described in the exclusion criteria AND there is agreement to allow by both
the investigator and Amgen

- Received live vaccine within 28 days prior to enrollment

- Exclusion of hepatitis infection based on the following results and/or criteria:
Positive for hepatitis B surface antigen (HBsAg) (indicative of chronic hepatitis B or
recent acute hepatitis B); Negative HBsAg and positive for hepatitis B core antibody:
hepatitis B virus DNA by polymerase chain reaction (PCR) is necessary. Detectable
hepatitis B virus DNA suggests occult hepatitis B

- Positive Hepatitis C virus antibody (HCVAb): hepatitis C virus RNA by PCR is
necessary. Detectable hepatitis C virus RNA suggests chronic hepatitis C

- History or evidence of any other clinically significant disorder, condition or disease
that, in the opinion of the investigator or Amgen physician, if consulted, would pose
a risk to subject safety or interfere with the study evaluation, procedures or
completion

- Other exclusion criteria may apply