| Eligibility |
Inclusion Criteria:
1. Willing and able to provide written informed consent form for the study prior to the
performance of any study-specific procedures.
2. Greater than or equal to 18 years of age at the time of screening.
3. Histologically or cytologically confirmed diagnosis of metastatic solid tumor that is
not amenable to curative therapy unless participation in the study would delay
standard therapy.
4. Eastern Cooperative Oncology Group performance status of 0 to 1.
5. Adequate organ function defined as:
1. Platelet count =100 × 109/L with no platelet transfusions in the past 7 days
2. Absolute neutrophil count =1.5 × 109/L
3. Hemoglobin =9 g/dL (red blood cell transfusion may be used to reach 9 g/dL but
must have been administered at least 1 week prior to the administration of the
study drug)
4. Aspartate aminotransferase or alanine aminotransferase <3 × the upper limit of
normal (ULN) if no hepatic metastases are present; <5 × ULN if hepatic metastases
are present
5. Total bilirubin <1.5 × ULN; <3 × ULN in the presence of Gilbert's disease
6. Estimated (Cockcroft-Gault formula) or measured creatinine clearance =50 mL/min
6. At least 1 target lesion per Response Evaluation Criteria in Solid Tumors version 1.1
(at least 10 mm per MRI from fludeoxyglucose [FDG] PET-MRI).
7. Women of childbearing potential must either abstain from sexual intercourse or employ
highly effective contraception measures during the study and for at least 30 days
after the administration of the study drug. Highly effective measures include 2 forms
of contraception. Postmenopausal or surgically sterile women (ie, hysterectomy,
bilateral salpingectomy, and bilateral oophorectomy) are eligible. Postmenopausal
status is defined as either: amenorrheic for =12 months following cessation of
exogenous hormonal treatments and without an alternative medical cause; luteinizing
hormone and follicle-stimulating hormone levels in the postmenopausal range for women
under 50 years of age; radiation-induced ovarian ablation with last menses =1 year
ago; or chemotherapy-induced menopause with a =1-year interval since last menses.
Female subjects must refrain from donating or banking eggs (ova, oocytes) and
retrieving eggs for use during study treatment and for 30 days after the
administration of the study drug.
8. Male subjects, if not surgically sterile, must either abstain from sexual intercourse
or employ highly effective contraception (condoms or other barrier forms of
contraception) during the study and for at least 30 days after the administration of
the study drug. Male subjects should also avoid semen donation or providing semen for
in vitro fertilization during the above-mentioned duration.
9. If a clinically indicated MRI is planned, it must be completed at least two weeks
prior to or at least two weeks post investigational drug administration.
Exclusion Criteria:
1. Unwilling or unable to comply with scheduled visits, study drug administration plan,
laboratory tests, or other study procedures and study restrictions.
2. QT interval corrected using Fridericia's formula >480 ms. Subject has a history of
prolonged QT syndrome or torsade de pointes. Subject has a familial history of
prolonged QT syndrome.
3. Clinically significant, uncontrolled cardiovascular disease including congestive heart
failure class III or class IV according to the New York Heart Association
classification; myocardial infarction or unstable angina within the previous 6 months;
uncontrolled hypertension (Grade 3 or higher); or clinically significant, uncontrolled
arrhythmia, including bradyarrhythmias that may cause QT prolongation (eg, type II
second-degree heart block or third-degree heart block).
4. Symptomatic central nervous system (CNS) metastases or primary CNS tumor that is
associated with progressive neurologic symptoms or requires ongoing corticosteroids to
control the CNS disease. Subject must have a stable neurologic status without steroid
support for at least 2 weeks before the start of study drug administration. Subjects
with stable or asymptomatic CNS metastases or primary CNS are eligible. Brain computed
tomography/MRI with or without contrast is mandatory within 4 weeks before the start
of study drug administration in case of clinical evidence of brain metastatic disease.
5. Subject who has received anticancer therapy (including both systemic therapy and
radiotherapy, but not including immunotherapy or other antibody therapies) within 14
days or 5 half-lives (whichever is shorter) of study drug administration or received
antibody therapy within 28 days before the start of study drug administration. The
study drug may be started within these washout periods if considered by the
investigator to be safe, except on the day of study drug administration.
6. Prior radiation therapy is allowed, provided >14 days have elapsed since completion of
radiation prior to enrollment. If target lesions were radiated, they should have
progressed prior to the administration of the study drug to be considered target
lesions per Response Evaluation Criteria in Solid Tumors version 1.1. If the prior
radiation exposure in research studies in the previous 12 months exceeds the current
guidelines (ie, 50 mSv/year), the subject will not be enrolled.
7. Administered a radioisotope within 10 physical half-lives before the start of study
drug administration.
8. Subject is unable to undergo or has a contraindication to PET or MRI scan.
- Subject who has electrical implants such as cardiac pacemaker or perfusion pump
- Subject who has claustrophobic reactions
- Body weight over the weight limit for the moving table (>300 lbs for the MRI)
- Unable to lie comfortably on a bed inside the PET scanner
- Metallic or electric implants contraindicated for PET-MRI scanning when
applicable
9. Subject who has an advanced solid tumor with metastasis to liver only, lymph nodes
only, or liver and lymph nodes only.
10. Subject who requires treatment with traditional/herbal medicines or their preparations
indicated for tumors or with adjuvant antitumor effects that cannot be discontinued
for the day of study drug administration.
11. Subject who received a major surgical procedure within 28 days before the start of
study drug administration (procedures such as central venous catheter placement and
tumor needle biopsy are not considered major surgical procedures). The study center
should discuss other minor surgeries with the sponsor.
12. History of another primary malignancy that has been diagnosed or required therapy
within the past year. Note: The following prior malignancies are not exclusionary:
completely resected basal cell and squamous cell skin cancer, curatively treated
localized prostate or breast cancer, curatively treated localized thyroid cancer, and
completely resected carcinoma in situ of any site.
13. Subject is pregnant at the time of screening or on Day 1 before the PET-MRI, as
documented by a serum beta human chorionic gonadotropin pregnancy test consistent with
pregnancy.
14. Subject is breastfeeding at the time of screening.
15. Known human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus
infection that meets the following criteria:
1. Subject with HIV infection is eligible if: documented with undetectable HIV RNA
within 4 weeks of study drug administration,
2. No acquired immunodeficiency syndrome defining opportunistic infections within
the past 12 months prior to study enrollment, and
3. Is on antiretroviral therapy for at least 4 weeks prior to study enrollment.
16. Presence of any severe or uncontrolled systemic disease or condition, including: (i)
uncontrolled hypertension or diabetes; (ii) serious cardiac, pulmonary, or renal
conditions; (iii) active bleeding diatheses; (iv) any active type of bacterial, viral,
fungal, or other infection that would pose a significant risk to the subject in the
opinion of the investigator.
17. Subject who has clinical signs or symptoms consistent with COVID-19 infection or
confirmed infection by appropriate laboratory test (done at the discretion of
investigator or per local regulation) within the last 2 weeks before the
administration of the study drug. In case of confirmed COVID-19 infection before
screening, documentation of resolution of infection by appropriate laboratory test is
required.
18. Subject who has received or is planning to receive a COVID-19 vaccination within 2
weeks before or after the administration of the study drug. However, COVID-19
vaccinations received >2 weeks before or after the administration of the study drug
are permitted.
19. Subject who has received a live or live attenuated vaccines within 30 days before the
administration of the study drug.
20. Any unresolved toxicities from prior therapy, greater than CTCAE Grade 1 at the time
of starting study treatment, with the exception of alopecia.
21. History of hypersensitivity to active or inactive excipients of the study drug or
drugs with a similar chemical structure or class to the study drug, including
ferumoxytol (Feraheme).
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