This study consists of two phases. The phase I study is designed to investigate the safety
and tolerability of Satoreotide tetraxetan following fractionated i.v. administrations in
pre-treated subjects with locally advanced or metastatic cancers expressing sstr2 as
identified by Satoreotide trizoxetan Positron Emission Tomography (PET/CT) scans. This phase
will encompass both radioactivity escalation and peptide mass dose evaluation. Phase II will
assess the efficacy of Satoreotide tetraxetan in subjects in selected indications, in a
- Consenting adults of Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or
- Histologically confirmed locally advanced or metastatic disease which has progressed
during or after, failed to respond to, or for which there is poor tolerability or
after a contraindication to available Standard of Care (SoC) treatment options as per
the assessment of the investigator; initially, subjects with the disease below may be
1. Subjects who had Extensive Disease (ED-SCLC) at presentation who have progressed
on or after one line standard chemotherapy. If a subject had Limited Disease
(LD-SCLC) at presentation and received surgery and/or radiotherapy as first line
treatment (with or without chemotherapy) and has localized relapse, further local
treatment (such as surgery) should be considered in addition to the chemotherapy
options; For subjects with either ED-SCLC or LD-SCLC, if subjects relapse more
than 6 months after first-line treatment, re-treatment with their initial regimen
is recommended. Subjects may have received prior immunotherapy.
2. Subjects with Human Epidermal Growth Factor Receptor (HR+)/(HER2-) metastatic BC
after a failure of prior SoC-treatments and who have received, if indicated, at
least one line of hormonal therapy, Cyclin-dependent kinase (CDK4/6) inhibitor
and/or everolimus for advanced or metastatic disease and at least one line of
chemotherapy for metastatic disease; subjects with a Breast Cancer (BRCA)-mutated
metastatic disease who may have received a Poly adenosine diphosphate ribose
polymerase (PARP) inhibitor, if available, are eligible; prior adjuvant hormonal
treatment and prior adjuvant chemotherapy are allowed.
- Documented progressive disease (radiological, based on RECIST v1.1) within 3 months
prior to first study drug administration. Screening study-related images should be
sent to the Imaging core laboratory (ICL).
- Adequate organ function determined within 28 days prior to 177Lu-OPS201
administration, defined as follows:
- Haematological: white blood cells (WBC) ≥3000/μL, with absolute neutrophil count
≥1000/μL, platelet ≥100,000/μL and haemoglobin ≥9 g/dL (without a need for
hematopoietic growth factor or transfusion support).
- Renal: Estimated glomerular filtration rate (eGFR) ≥55 mL/minute/1.73m2
- Hepatic: total serum bilirubin ≤2×ULN; aspartate aminotransferase/ alanine
aminotransferase ≤2.5×ULN (≤5×ULN if a subject has liver metastases)
- Formalin fixed paraffin embedded tumour sample (archival tumour sample obtained within
1 month prior to concent from the primary or metastatic lesion OR is willing to
undergo newly obtained biopsy prior to the first dose of study treatment. Subjects who
are unable or do not concent to provide acceptable tissue may not be enrolled unless
there has been prior agreement with the sponsor.
- 68Ga OPS202 uptake in the target tissue (a primary tumour, lymph nodes longest
diameter on PET/CT as confirmed by a central reader.
- Radiologically, ≥50% matching between the lesions detected on 68Ga OPS202-PET/CT and
on 18F-fluorodeoxyglucose (18F-FDG)-PET/CT as confirmed by central reader
- Male subjects with BC.
- Unstable central nervous system metastasis
- Centrally located lung tumours that show radiogical evidence (CT or MRI) of either:
- cavitation or necrosis, or
- focal invasion for major blood vessels.
- Subjects had received chemotherapy within the previous 4 weeks or had not recovered
from adverse events due to chemotherapy. Additional exclusion criteria were previous
hemibody external radiotherapy, systemic radiotherapy with radioisotopes within the
previous 24 weeks
- Previous chemotherapy within a cycle interval, curative radiotherapy within 4 weeks or
palliative radiotherapy within 7 days prior to Investigational radiopharmaceutical
product (IRPP) administration.
- Prior treatment with any other investigational medicinal product (IMP) within five
half-lives of the previous IMP or within 2 weeks, if the previous compound is a
mechanism-based molecularly targeted agent whose half-life is not well characterized
and toxicities have not resolved from Grade 2 or higher prior to IRPP administration.
- Any unresolved NCI-CTCAE Grade 2 or higher toxicity (except alopecia and Grade 2
platinum-therapy related neuropathy) from previous antitumour treatment and/or
- Nephrectomy, renal transplant or concomitant nephrotoxic therapy putting the subject
at high risk of renal toxicity during the study as assessed by the investigator.
- Any significant medical or surgical condition that would affect safety or the
assessment of efficacy or the ability of a person to comply with the protocol.
- Any condition that precludes the proper performance of PET and/or SPECT scans, CT
scans and/or MRI:
1. subjects who are not able to tolerate the CT contrast agent.
2. subjects with metal implants or joint prosthesis (depending on the location, if
interferes with the PET and/or CT analysis)
3. or any other objects that might interfere with the PET and/or CT analysis.
4. subjects unable to raise arms for prolonged imaging purposes.
5. subjects unable to lie still for the entire imaging time.
6. subjects weighing greater than 130 kg (287 lb).
- Pregnant or lactating female. Female subject of childbearing potential who is
unwilling to use acceptable method(s) of effective contraception during study
treatment and through 6 months after the last dose of 177Lu-OPS201.
- Male subject who is unwilling to use acceptable method of effective contraception
during treatment and through 6 months after the last dose of 177Lu-OPS201.