This trial is a phase 1, single-centre, open label, single-dose study of 89Zr-APOMAB using PET/CT imaging in a series of 18 participants who are known to have inoperable stage III or stage IV non-small cell lung cancer (NSCLC), or limited or extensive stage small cell lung cancer (SCLC), or FIGO stage IV grade 3 serous papillary Ovarian Cancer.
A Phase 1, Single-Centre, Non-Randomised, Open-Labelled, 2-Arm, Single Dose study of Chimeric Anti-La/SSB Antibody (APOMAB) Conjugated with 89Zirconium-Label (89Zr-APOMAB) as a Theranostic Imaging Agent Using ImmunoPET/CT in Patients with Advanced Lung or Ovarian Cancer
Central Adelaide Local Health Network
18 participants
Jun 1, 2020
Interventional
Conditions
Summary
The purpose of this study is to determine if APOMAB, (an imaging agent which is an antibody with a small amount of radiation attached to it) which has been designed to detect tumour cell death, is safe and tolerable to use in humans. The APOMAB trial will be done in two stages. In the first stage of the trial in 6 participants, you will receive the APOMAB injection if you have an advanced lung or ovarian cancer but only if you are not receiving any chemotherapy at the time that the APOMAB injection is planned. In the second stage of the trial in 12 participants, you will receive the APOMAB injection after the first cycle of standard chemotherapy for your advanced lung or ovarian cancer. If you are an adult, have received a new diagnosis of advanced lung or ovarian cancer, and you have either commenced or are about to commence platinum based chemotherapy, then you may be asked to consider participating in this study, and if you agree, then you will be asked to sign a consent form. There are a number of tests and procedures which need to be carried out to determine if you would be eligible to take part in this study. This is called the 'screening period', and can take up to 14 days to complete. During this period you will be reviewed by a doctor who will take a full medical history, perform a physical exam, an ECG ( a non-invasive test of the electrical activity of your heart), routine blood tests, collection of small amount of blood for study purposes, a FDG-PET/CT scan if this has not been recently performed, once all test results have been reviewed and the study doctor confirms that you are eligible for the study, a date will be organised for you to receive an injection of the study drug APOMAB. Prior to the injection, the study doctor will review you again, you will remain at the imaging centre for approximately 4-5 hours post injection, as a number of scans will be collected as well as blood and urine samples on this day. You will be required to undergo further medical reviews and scans, with further blood and urine samples to be collected on Days 2, 4, 8 & 13 post injection. No other visits will be required for study purposes. You will then either commence or continue your standard chemotherapy treatment. The results of this study will help further the development of immunoPET/CT with APOMAB. We are aiming to find out whether an early indication of tumour cell death on APOMAB immunoPET/CT scans before a patient has a second cycle of chemotherapy increases the likelihood that tumours in the body shrink. Having this information sooner in the treatment course may allow future cancer patients to know that effective treatment can continue even in spite of side effects. Also future cancer patients can know that ineffective treatment can be discontinued, thus avoiding side effects without any prospect of benefit, and allow these patients to choose an alternative treatment sooner rather than later.
Eligibility
Inclusion Criteria17
- Signed informed consent
- Age greater than or equal to18 years
- ECOG performance status 0-1
- Life expectancy of greater than or equal to12 weeks
- Histologically confirmed, inoperable stage III or IV non-small cell lung cancer (NSCLC) or limited or extensive stage small cell lung cancer (SCLC) suitable for palliative platinum-based chemotherapy, OR
- Histologically confirmed, FIGO stage III or IV high-grade serous ovarian cancer (HGSOC) suitable for palliative or neoadjuvant platinum-based doublet chemotherapy
- Must have sufficient tumour tissue available for assessment of homologous recombination deficiency (HRD). If not, a fresh tumour biopsy may be required
- At least one area of disease measurable by RECIST v1.1 on CT or MRI at baseline before study entry
- Adequate liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening
- Estimated glomerular filtration rate (eGFR) of greater than or equal to 40mL/min as measured using the Cockroft Gault formula
- Total bilirubin less than or equal to 1.5x the upper limit of normal (ULN)
- ALT and AST less than or equal to 2.5x ULN (less than or equal to 5x ULN for participants with liver involvement of their cancer)
- Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment. Both men and women enrolled in this trial must agree to follow any of these measures if not surgically sterile during the course of the trial
- Total abstinence from sexual intercourse
- Double barrier methods (e.g. cervical cap, condom, contraceptive sponge, diaphragm or vaginal ring).
- Intrauterine device
- Contraception is necessary for at least 7 weeks after receiving the study drug
Exclusion Criteria11
- Pregnant or breastfeeding females.
- Participants with prior exposure to any chimeric antibodies and mouse proteins will be excluded.
- Known uncontrolled hyperthyroidism
- Exposure to any experimental diagnostic or therapeutic drug within 30 days from the date of planned administration of 89Zr-APOMAB
- Exposure to any radiopharmaceutical within 30 days before the administration of 89Zr-APOMAB.
- Diagnosis of systemic lupus erythematosis or Sjögren Syndrome or presence of antinuclear antigen (ANA) titre of = 1:160 or extractable nuclear antigen (ENA) antibodies
- Women (with or without a systemic autoimmune disease) who have a history of giving birth to a child with congenital heart block
- Grade = 2nd degree atrioventricular block on ECG
- Psychiatric illness or social situations that could limit compliance to the study requirements
- Participants unwilling or unable to provide written informed consent
- In the opinion of the investigator, the participant is not suitable to receive 89Zr-APOMAB
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Interventions
Theranostic Interventions: Single dose of 37MBq of 89Zr-APOMAB will be given intravenously to each patient participating in the study: 1. Patients participating in Stage 1 (untreated population - in the first stage, the untreated groups of patients will have completed the post-antibody imaging at completion of this study before commencing any chemotherapy, planned or unplanned. These patients will not participate in the second stage of the study): On day of study drug (APOMAB) injection (Study Day 1) 2. For patients enrolled in Stage 2 (treated population - this group of patients will have initiated a first cycle of first-line platinum based chemotherapy before antibody injection. Again, patients will have completed the post-antibody imaging at completion of this study before commencing the second cycle of chemotherapy): 89Zr-APOMAB to be given on Day 1, which is the day after Cycle 1 Day 8 (i.e. C1D9) of platinum based chemotherapy (PBCT). APOMAB and 89Zr-APOMAB are both names used for the same formulation within this protocol. Patients will be consented, screened & deemed to be eligible to participate in study, 89Zr-APOMAB will be administered and images collected, safety reviews and follow-ups will be scheduled. Patients will still receive routine care for their standard of care chemotherapy treatment where planned. An imaging manual will be followed for each dosing and image collection procedure. Each study participants study procedures will be documented and a record will be kept within our RAH Cancer Clinical Trials Unit.
Locations(1)
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ACTRN12620000622909