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 | Terminated Phase 1 Results DMC FDA Drug

• 2 other identifiers: D-FR-01072-0022017-005173-39
• Study Type: interventional
• Target: 9
• Locations: 7 countries
• Sites: 8

Brief Summary

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.

Conditions

Small Cell Lung Cancer and Breast Cancer

Outcome Measures

Primary Outcomes (2)

• Maximum Tolerated Cumulative Activity - Phase I

  From Day 1 (first administration of 177Lu-satoreotide tetraxetan) up to 6 weeks after the second administration; no longer applicable due to early study termination.

• Objective Response Rate Over the Two Treatment Cycles - Phase II

  6 weeks after each administration of 177Lu-satoreotide tetraxetan during the core study or at occurrence of first clinical signs of disease progression as determined by the investigator, up to 90 days; no longer applicable due to early study termination.

Study Arms (1)

Treatment

EXPERIMENTAL

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

Drug: Satoreotide tetraxetan; Drug: Satoreotide trizoxetan

Interventions

Satoreotide tetraxetan DRUG

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).

Also known as: 177Lu-OPS201

Treatment

Satoreotide trizoxetan DRUG

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

Also known as: 68Ga-OPS202

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Consenting adults of Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
• 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 considered:
• 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.
• 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.
• Ga 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

You may not qualify if:

• 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.
• 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 medical/surgical procedures/interventions.
• 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:
• subjects who are not able to tolerate the CT contrast agent.
• subjects with metal implants or joint prosthesis (depending on the location, if interferes with the PET and/or CT analysis)
• or any other objects that might interfere with the PET and/or CT analysis.
• subjects unable to raise arms for prolonged imaging purposes.

Sponsors & Collaborators

• Ipsen: lead

Study Sites (8)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Medical University of Innsbruck

Innsbruck, 6020, Austria

Location

University Hospital (UZ) Leuven

Leuven, 3000, Belgium

Location

CHU de Marseille - Hôpital la Timone

Marseille, 13385, France

Location

CHU de Bordeaux - Hôpital Haut Lévêque

Pessac, 33604, France

Location

Universitaetsklinikum Essen

Essen, 45122, Germany

Location

University Hospital Basel

Basel, CH-4031, Switzerland

Location

Royal Marsden Hospital - Surrey

Sutton, SM2 5PT, United Kingdom

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma; Breast Neoplasms

Interventions

177Lu-DOTA-JR11

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

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.

Results Point of Contact

• Title: Ipsen Medical Director
• Organization: Ipsen

clinical.trials@ipsen.com

See email

Study Officials

• Ipsen Medical Director

  Ipsen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2018
• First Posted: December 12, 2018
• Study Start: May 14, 2019
• Primary Completion: October 10, 2019
• Study Completion: October 10, 2019
• Last Updated: September 13, 2022
• Results First Posted: October 30, 2020

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); US (1); FR (2); DE (1); BE (1); CH (1); GB (1)