Inclusion Criteria :
- Signed informed consent form prior to all study procedures
- Aged 18 years or older.
- Histologically or cytologically confirmed unresectable locally advanced or metastatic
disease and has received prior lines of standard-of-care chemotherapy/treatment and
has no further suitable treatment options and documented decision by a
multidisciplinary oncology board including a specialist of the concerned pathology.
- Subjects have (a) pancreatic ductal adenocarcinoma (PDAC), or (b) colorectal cancer
(CRC), or (c) gastric adenocarcinoma (GC), or (d) gastrointestinal stromal tumours
(GIST), or (e) squamous-cell carcinoma of head and neck (SCCHN), or (f) Ewing Sarcoma
(ES)
- Tumour showing: (a) by uptake of 177Lu-3BP-227 (screening formulation) in known
primary or metastatic sites as judged by the investigator to be greater than
background; or (b) uptake of 111In 3BP 227 in known primary or metastatic sites (for
subjects who participated in Study D FR 01087 002) as judged by the investigator to be
greater than background.
- Measurable disease (based on RECIST version1.1).
- Documentation of progressive disease in the 6 months prior to study start (treatment).
- Eastern Cooperative Oncology Group performance status of 0 or 1 (unless if disability
is related to surgery in ES and Agreed with the Sponsor).
- Adequate organ function as evidenced by: (a) Leukocytes ≥3000/μL (b) Absolute
neutrophil count ≥1500/µL (c) Platelets ≥75,000/µL (d) Hb >9 g/dL or >10 g/dL (if
history of cardiac disease) (e) Total serum bilirubin ≤2 times upper normal
institutional limits (ULN) (f) Aspartate aminotransferase/alanine aminotransferase
(ALT) ≤2.5×ULN (or ≤5×ULN, if subject has liver metastases) (g) Estimated glomerular
filtration rate (eGFR) ≥55 mL/min.
- Estimated life expectancy >3 months.
- Female subjects must not be pregnant or lactating at study entry and during the course
of the study and must not become pregnant for at least 6 months following the last
study treatment. Women of childbearing potential must agree to use a highly effective
method of contraception
- For male subjects, must not father children during the study and for at least 6 months
after the last study treatment and in addition must agree to use a condom for this
period to protect his partner from contamination with the IMP. For males with partners
who are of child bearing potential, effective contraception is a combination of male
condom with either cap, diaphragm or sponge with spermicide (double barrier methods),
but these are not considered to be highly effective. A man is considered to be
infertile if he has had bilateral orchidectomy or successful vasectomy. Effective
contraception includes a female partner of childbearing potential if she is using
highly efficacious contraception, but the male subject must agree to use a condom to
protect his partner as described above.
- Must be willing and able to comply with study restrictions and to remain at the clinic
for the required time during the study period and willing to return to the clinic for
the follow-up evaluation, as specified in the protocol.
Exclusion Criteria :
- Prior treatment received (a) Any antitumor treatment since last documented disease
progression (b) Any chemotherapy within 3 weeks or nitrosourea within 6 weeks prior to
first treatment investigational medicinal product (IMP) administration (c) Any
curative radiotherapy within 4 weeks, or palliative radiotherapy within 7 days prior
to first treatment IMP administration (d) Any monoclonal antibodies within 4 weeks or
tyrosine kinases inhibitors within 2 weeks prior to the first treatment IMP
administration, (e) Any other IMP within 2 weeks prior to first treatment IMP
administration, if the previous compound is a mechanism-based molecularly targeted
agent whose half-life (t1/2) is not well-characterized.
- Brain metastases.
- Nephrectomy, renal transplant or concomitant nephrotoxic therapy putting the subject
at high risk of renal toxicity during the study.
- Only non-measurable metastatic bone lesions
- Existing or planned colostomy during study participation.
- Any history of inflammatory bowel disease.
- Any uncontrolled significant medical, psychiatric or surgical condition or laboratory
finding, that would pose a risk to subject safety or interfere with study
participation or interpretation of individual subject results.
- Clinically significant abnormalities on electrocardiogram (ECG) at screening including
corrected QT interval (Fridericia's formula) >450 msec for males or 470 msec for
females at screening.
- Previously received external beam irradiation to a field that includes more than 30%
of the bone marrow or kidney.
- Any unresolved NCI-CTCAE Grade 2 or higher toxicity (except alopecia) from previous
antitumor treatment and/or medical/surgical procedures/interventions.
- Known allergy to IMP or its excipients administered in this study, including imaging
contrast media.
- Positive pregnancy test (female subjects).
- Likely to be uncompliant or uncooperative during the study, in the judgment of the
investigator.
- Unable to understand the nature, scope, and possible consequences of the study, in the
judgment of the investigator.
- Sponsor employees or investigator site personnel directly affiliated with this study,
and their immediate families. Immediate family is defined as a spouse, parent, child
or sibling, whether biological or legally adopted.
