Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Rare Diseases

Small Cell Lung Carcinoma

Breast Neoplasms

Neoplasm Metastasis

Lung Neoplasms

Carcinoma

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Neoplastic Processes

Small Cell Lung Cancer

All Drugs and Chemicals

Somatostatin

1,4,7,10-tetraazacyclododecane- 1,4,7,10-tetraacetic acid

Chelating Agents

i.v. administrations of up to three radioactivity levels of Satoreotide tetraxetan.

Radioactivity delivered in 2 administrations (cycles): one loading dose followed by a lower maintenance dose, 6 weeks apart until progression or unacceptable toxicity (up to 4 additional cycles could be administered depending on efficacy and tolerability).

Satoreotide tetraxetan

Imaging companion: 1 administration at screening and one administration at End of core Trial cycle.

Satoreotide trizoxetan

Ipsen Medical Director

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 basket design.

Evaluate the Safety, Tolerability, Biodistribution and Anti Tumour Activity of 177LU-OPS201 With Companion Imaging 68Ga-OPS202 PET/CT in Previously Treated Subjects With Locally Advanced or Metastatic Cancers Expressing Somatostatin Receptor 2 (SSTR2)

A Multicentre, Open-Label Phase I/II Study to Evaluate the Safety, Tolerability, Biodistribution and Anti Tumour Activity of 177LU-OPS201 With Companion Imaging 68Ga OPS202 PET/CT in Previously Treated Subjects With Locally Advanced or Metastatic Cancers Expressing Somatostatin Receptor 2 (SSTR2)

Ipsen

The 68Ga-satoreotide trizoxetan safety population included all subjects who received at least 1 dose of 68Ga-satoreotide trizoxetan.

68Ga-satoreotide Trizoxetan Safety Population

In the screening period, 8 subjects received a single i.v. injection of IIP, 68Ga-satoreotide trizoxetan with a peptide mass of up to 45 ug and a radioactivity dose range of 150-200 MBq for screening purposes. The PET images were acquired at 1-hour post injection and 1 contrast enhanced CT scan was performed.

Screened Subjects

Age, Categorical

Sex: Female, Male

Race (NIH/OMB)

Baseline characteristics are reported for all subjects who received at least 1 dose of the IIP, 68Ga-satoreotide trizoxetan for screening purposes.

This study was terminated early due to unsuccessful screening and not due to subjects' safety. No outcomes measures were evaluated as no subjects received the therapeutic IRPP, 177Lu-satoreotide tetraxetan.

In the core treatment period of Phase I, eligible subjects were to receive up to 2 i.v. administrations of 177Lu-satoreotide tetraxetan. A range of cumulative radioactivities from 9 to 12.9 Gigabecquerels of 177Lu-satoreotide tetraxetan, fractionated into 2 administrations 6 weeks apart, were planned to be tested.

All Subjects - Phase I

No efficacy data was collected since none of the subjects received the IRPP, 177Lu-satoreotide tetraxetan.

Maximum Tolerated Cumulative Activity - Phase I

Subjects were to receive the recommended Phase II 177Lu-satoreotide tetraxetan treatment regimen based on the dose-response and exposure-response analyses of Phase I. It was expected that 2 treatment cycles of 177Lu-satoreotide tetraxetan would be administered in subjects enrolled in Phase II.

All Subjects - Phase II

Objective Response Rate Over the Two Treatment Cycles - Phase II

In the screening period, 8 subjects received a single intravenous (i.v.) injection of IIP, 68Ga-satoreotide trizoxetan with a peptide mass of up to 45 micrograms (ug) and a radioactivity dose range of 150-200 Megabequerel (MBq) for screening purposes. The PET images were acquired at 1-hour post injection and 1 contrast enhanced CT scan was performed.

Overall Study

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Neuroendocrine Tumor

Gastro-enteropancreatic Neuroendocrine Tumor

Pancreatic Neuroendocrine Tumor

Neuroepithelioma

Satoreotide trizoxetan will be administered in two sequentially ascending peptide doses

satoreotide trizoxetan

The purpose of this study is to assess the safety and tolerability of 68Ga-OPS202 used for the diagnosis of gastroenteropancreatic neuroendocrine tumors (GEP NETs).

68Ga-OPS202 Study for Diagnostic Imaging of GEP NET

An Open-label, Micro-dosing Study to Evaluate Safety, Biodistribution, Dosimetry and Preliminary Efficacy of Two Single 68Ga-OPS202 Doses for the Diagnostic Imaging of Somatostatin Receptor-positive Gastro-entero-pancreatic Neuroendocrine Tumors (GEP NET) Using Positron-emission Tomography / Computed Tomography (PET/CT)

An AE was defined as any untoward medical occurrence in a participant administered a IP and which does not necessarily have a causal relationship with this treatment. For this study, all AEs were regarded as 'treatment emergent', i.e., not seen before administration of the IP or, if already present before administration, worsened after start of administration. An SAE was defined as an event that led to death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect. An ADR was defined as an AE with probable, possible or unlikely relationship to the administration of 68Ga-OPS202.

Laboratory assessments included hematology, blood biochemistry and urine analysis. Vital signs included systolic and diastolic blood pressure, heart rate and axillary body temperature. Cardiac safety was assessed by 12-lead ECGs and physical examination included general appearance, head, neck, eyes, ears, nose, throat, respiratory, cardiovascular, gastrointestinal, musculoskeletal, neurological, endocrine, lymphatic, dermatological, psychological/psychiatric, abdomen, and genitourinary body systems. All medications (including herbal products) taken from visit 1 (Day 0) to visit 3 (7-15 days after visit 2 (3-4 weeks after visit 1), end of the study) were recorded in the participant's case report form.

At visit 1, after administration of 15 μg 68Ga-OPS202, a dynamic scan was performed in kidney region over first 30 minutes; static scans were performed from head to sub-inguinal region at 0.5, 1, 2 and 4 h post-injection. At visit 2, after administration of 50 μg 68Ga-OPS202, a static scan was performed from head to sub-inguinal region at 1 h post-injection. A previous somatostatin receptor scan had been performed within 6 months prior to Day 0. Lesions were classified into malignant and benign by readers. Lesion matching was performed between somatostatin receptor scan and 1 h-68Ga-OPS202 receptor scans at visit 1 and visit 2. Number of lesions for each organ/tissue and overall were calculated and absolute numbers reported. Two different read sessions were held to generate data sets for evaluation of target variables. Statistical comparisons were only feasible for those organs/ tissues that had sufficient participants with lesions detected.

Tumor contrast in PET imaging was determined by qualitative visual analysis. 68Ga-OPS202 binding was present if at least one lesion, regardless of nature, was detected within respective tissue location. Percentages were based on number of participants with available scan at corresponding time point.

At visit 1, after administration of 15 μg 68Ga-OPS202, a dynamic scan was performed in kidney region over the first 30 minutes (0-0.5 h); static scans were performed from head to sub-inguinal region at 0.5, 1, 2 and 4 h post-injection. At visit 2, after administration of 50 μg 68Ga-OPS202, a static scan was performed from head to sub-inguinal region at 1 h post-injection. A previous somatostatin receptor scan had been performed within 6 months prior to Day 0. Lesions were classified into malignant and benign lesion by the readers according to their experience. Lesion matching was performed between the somatostatin receptor scan and the 1 h-68Ga-OPS202 receptor scans at visit 1 and visit 2. The mean SUVmax of lesions (mean of all identified lesions in the lymph node and liver) was summarized by nature of the lesions (malignant, benign). Statistical comparisons were only feasible for those organs/ tissues that had sufficient participants with lesions detected.

The mean SUVmax of all identified lesions in the respective organ/tissue was determined. Statistical comparisons were only feasible for those organs/ tissues that had sufficient participants with lesions detected.

Lesion matching was performed between somatostatin receptor scan and 1 h-68Ga-OPS202 receptor scans at visit 1 and visit 2. Mean SUVmax of all selected ROIs in corresponding RT was determined. Corresponding RTs were adjacent healthy regions (1 to 3 healthy regions were identified for each lesion), i.e. located in same organ and/or region as lesion. RTs were determined in tissue locations with malignant lesions only. ROIs were also selected in muscle tissue, which was used as an additional reference region. Statistical comparisons were only feasible for those organs/ tissues that had sufficient participants with lesions detected.

The mean SUVmax of all selected ROIs in the corresponding RT was determined. RTs were determined in tissue locations with malignant lesions only. ROIs were also selected in muscle tissue, which was used as an additional reference region. Statistical comparisons were only feasible for those organs/ tissues that had sufficient participants with lesions detected.

The tumor contrast, i.e. the SUV ratio for tumor (malignant lesion)-to-background (3D-SUV-R) of a single lesion was defined as: 3D-SUV-R = SUVmax of lesion / mean of SUVmax of corresponding RTs. Statistical comparisons were only feasible for those organs/ tissues that had sufficient participants with lesions detected.

The tumor contrast, i.e. the SUV ratio for 3D-SUV-R of a single lesion was defined as: 3D-SUV-R = SUVmax of lesion / mean of SUVmax of corresponding RTs. Statistical comparisons were only feasible for those organs/ tissues that had sufficient participants with lesions detected.

The tumor contrast, i.e. the SUV ratio for 3D-SUV-R of a single lesion was defined as: 3D-SUV-R = SUVmax of lesion / mean of SUVmax of corresponding RT. For percent change, 68Ga-OPS202 receptor scan is compared to previous somatostatin receptor scan.

For determining a suitable time window for PET/CT with 68Ga-OPS202, the scans after administration of the 15 μg peptide dose were analyzed and the time point with the highest lesion number per tissue location and overall were determined. If the highest number of lesion was detected at more than one time point, the earliest time point was used.

The time point with the highest mean 3D-SUV-R per tissue location were determined. If the highest mean 3D-SUV-R was detected at more than one time point, the earliest time point was used.

The assessment of every diagnostic 68Ga-OPS202 PET/CT scan of session 2 was rated by the reader from 1 to 5, where 1=worst diagnostic scan and 5=best diagnostic scan. Higher score indicates a better scan.

The SAF included all participants of the FAS who received the IP, regardless of any protocol deviations.

Participants received a single dose of the OPS202 peptide (15 \[± 5\] μg on Day 0. All doses were labeled with 68Ga at a fixed dose of 200 MBq (± 25%) per injection. 68Ga-OPS202 was administered intravenously over a time period of less than 1 minute prior to 3D PET/CT scan. As per the sequential dosing scheme, on Day 21, participants then received a single dose of 50 (± 15) μg of 68Ga-OPS202 prior to 3D PET/CT.

All Participants

Age, Continuous

Safety analysis set (SAF) included all participants of the full analysis set (FAS) who received the IP, regardless of any protocol deviations.

Medical Director

Any AE

SAEs

ADRs

Number of Participants Reported With Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Drug Reactions (ADRs)

Laboratory parameters abnormalities

Vital sign abnormalities

12-Lead ECG abnormalities

Physical examination abnormalities

Concomitant medications required

The SAF included all participants of the FAS who received the investigational product, regardless of any protocol deviations.

Number of Participants With Clinical Significant Abnormalities in Laboratory Parameters, Vital Signs, Cardiac Safety, Physical Examination, and Required Concomitant Medication

Comparison of malignant lesions in total tissues between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.

Comparison of malignant lesions in total tissues between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.

Comparison of malignant lesions in liver between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.

Comparison of malignant lesions in liver between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.

Comparison of malignant lesions in lymph node between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.

Comparison of malignant lesions in lymph node between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.

Malignant: Total

Malignant: Bone

Malignant: Liver

Malignant: Lymph node

Malignant: Peritoneum

Malignant: Small bowel

Benign: Total

Benign: Lung

Benign: Lymph node

Benign: Mamma

Benign: Mediastinum

Benign: Pancreas

Benign: Small bowel

Benign: Spleen

Benign: Stomach

Benign: Thyroid gland

Participants had a somatostatin receptor scan performed within 6 months prior to the first injection of IP.

ITT Population (Pre-dose)

Participants received a single intravenous dose of 15 (± 5) μg of OPS202 peptide plus 68Ga at a fixed dose of 200 MBq (± 25%) per injection on Day 0 prior to PET/CT scan.

ITT Population (Day 0)

Participants received a single intravenous dose of 50 (± 5) μg of OPS202 peptide plus 68Ga at a fixed dose of 200 MBq (± 25%) per injection on Day 21 prior to PET/CT scan.

ITT Population (Day 21)

The Intention-to-Treat (ITT) set included all participants of the FAS who received the IP and had at least 1 evaluable PET/CT scan image available for at least 1 time point at visit 1 (Day 0) or visit 2 (Day 21), regardless of any protocol deviations.

Number of Malignant and Benign Lesions Detected for Session 1

Total: At 0.5 hour

Total: At 1 hour

Total: At 2 hour

Total: At 4 hour

Bone: At 0.5 hour

Bone: At 1 hour

Bone: At 2 hour

Bone: At 4 hour

Liver: At 0.5 hour

Liver: At 1 hour

Liver: At 2 hour

Liver: At 4 hour

Lung: At 0.5 hour

Lung: At 1 hour

Lung: At 2 hour

Lung: At 4 hour

Lymph node: At 0.5 hour

Lymph node: At 1 hour

Lymph node: At 2 hour

Lymph node: At 4 hour

Mamma: At 0.5 hour

Mamma: At 1 hour

Mamma: At 2 hour

Mamma: At 4 hour

Pancreas: At 0.5 hour

Pancreas: At 1 hour

Pancreas: At 2 hour

Pancreas: At 4 hour

Peritoneum: At 0.5 hour

Peritoneum: At 1 hour

Peritoneum: At 2 hour

Peritoneum: At 4 hour

Small bowel: At 0.5 hour

Small bowel: At 1 hour

Small bowel: At 2 hour

Small bowel: At 4 hour

Thyroid gland: At 0.5 hour

Thyroid gland: At 1 hour

Thyroid gland: At 2 hour

Thyroid gland: At 4 hour

The ITT set included all participants of the FAS who received the IP and had at least 1 evaluable PET/CT scan image available for at least 1 time point at visit 1 (Day 0) or visit 2 (Day 21), regardless of any protocol deviations.

Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding

Comparison of SUVmax of malignant lesions in liver between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.

Comparison of SUVmax of malignant lesions in liver between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.

Comparison of SUVmax of malignant lesions in lymph node between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.

Comparison of SUVmax of malignant lesions in lymph node between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.

Mean Maximum Standardized Uptake Value (SUVmax) of Malignant and Benign Lesions for Session 1

Comparison of SUVmax of malignant lesions in liver between 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.

Comparison of SUVmax of malignant lesions in lymph node between 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluate the Safety, Tolerability, Biodistribution and Anti Tumour Activity of 177LU-OPS201 With Companion Imaging 68Ga-OPS202 PET/CT in Previously Treated Subjects With Locally Advanced or Metastatic Cancers Expressing Somatostatin Receptor 2 (SSTR2)	NCT03773133	Small Cell Lung...	Satoreotide tet... Satoreotide tri...	18 Years -	Ipsen
68Ga-OPS202 Study for Diagnostic Imaging of GEP NET	NCT02162446	Gastroenteropan...	satoreotide tri...	18 Years -	Ipsen
Evaluate the Safety, Tolerability, Biodistribution and Anti Tumour Activity of 177LU-OPS201 With Companion Imaging 68Ga-OPS202 PET/CT in Previously Treated Subjects With Locally Advanced or Metastatic Cancers Expressing Somatostatin Receptor 2 (SSTR2)	NCT03773133	Small Cell Lung...	Satoreotide tet... Satoreotide tri...	18 Years -	Ipsen
68Ga-OPS202 Study for Diagnostic Imaging of GEP NET	NCT02162446	Gastroenteropan...	satoreotide tri...	18 Years -	Ipsen
Define the Optimal Uptake Time of 68Ga-OPS202 When Used as a PET (Positron Emission Tomography) Imaging Agent in Subjects With Newly Diagnosed Breast Cancer	NCT03697551	Breast Cancer	Satoreotide tri...	18 Years -	Ipsen

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