Theranostics in Soft Tissue Sarcoma Using a Vascular Disruption Approach (ThernSarc)

To test the feasibility of theranostic targeting the PSMA receptor in STS patients by Ga-68-PSMA-11 PET/CT and Lu-177-ITG-PSMA-1 treat-ment with special emphasis on vascular disruption using a translational approach.

Study Overview

• Status: Completed
• Conditions: Soft Tissue Sarcoma
• Intervention / Treatment: Drug: Ga-68-PSMA-11 PET/CT; Drug: Lu-177-ITG-PSMA-1

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 1

Contacts and Locations

Study Locations

• Switzerland
  • Vaud
    • Lausanne, Vaud, Switzerland, 1011
      • Centre Hospitalier Universitaire Vaudois

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Female or male ≥ 18 years old at the time of informed consent
• Patients with proven Soft Tissue Sarcoma
• Patients need to pass the sarcoma tumor board and the molecular tumor board at CHUV and no approved therapeutic alternative is available
• Progression of the disease by RECIST v1.1 after standard therapies according to the treat-ing oncologists
• Informed Consent as documented by signed informed consent form

Exclusion Criteria:

• Patients under active anti-sarcoma treatment other than the study product (Lu-177-ITG-PSMA-1)
• Female participants who are pregnant or breast feeding
• Female participants with intention to become pregnant during the course of the study
• Lack of safe contraception, defined as: Female participants of childbearing potential, not us-ing and not willing to continue using a medically reliable method of contraception for the en-tire study duration until 6 months after last Lu-177-ITG-PSMA-1 treatment, such as oral, in-jectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases. Male patients of reproductive potential, not using and not willing to use a medically reliable method of contraception for the entire study duration until 6 months after last Lu-177-ITG-PSMA-1 treatment, such as barrier method or sexual abstinence or who are not using any other method considered sufficiently reliable by the investigator in individual cases. The par-ticipant must inform their female partners about the participation in this trial and they must use additional effective contraception (e.g., hormonal) during the trial until 6 months after the last Lu-177-ITG-PSMA-1 treatment.
• Previous enrolment into the current study
• History of any disease or relevant physical condition or abnormal physical finding which may interfere with the study objectives at the investigator judgment
• Insufficient knowledge of project language, inability to give consent or to follow procedures, incapacity to follow radiation safety procedures, required by the study
• Enrolment of the investigator, his/her family members, employees and other dependent per-sons
• The patient makes use of his/her "right not to know" and refuses to be informed about inci-dental findings
• Absence of PSMA accumulation in at least 50% of tumours on Ga-68-PSMA-11 PET/CT
• Grade IV renal impairment and above (calculated GFR < 30 mL/min/1.73 m2)
• Blood count disturbance:

Platelets < 75,000/µL. Leukocytes < 2,500/µL Haemoglobin < 80 g/L. • Disturbance of liver function with: Total bilirubin > 2 times the upper limit of the norm ASAT/ALAT > 3 times the upper limit without the presence of liver metastases ASAT/ALAT > 5 times the upper limit in the presence of liver metastases

• Hypersensitivity to any of the ingredients of the injectable product

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Positive Ga-68-PSMA-11 PET/CT patients treated by Lu-177-ITG-PSMA-1; Positive Ga-68-PSMA-11 PET/CT prior to two cycles of Lu-177-ITG-PSMA-1 i scheduled six weeks apart.	Drug: Ga-68-PSMA-11 PET/CT; Ga-68-PSMA-11 PET/CT imaging; Drug: Lu-177-ITG-PSMA-1; Lu-177-ITG-PSMA-1 treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
imaging result obtained by Ga-68-PSMA-11 PET/CT	four weeks after the second cycle of Lu-177-ITG-PSMA-1 treatment, compared to base-line

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SUVmax and radiological changes using PSMA - PET/CT	SUVmax and radiological changes using PSMA - PET/CT using advanced radiological assessment including CHOI criteria to as-sess the necrosis one month after end of second cycle	four weeks after the second cycle of Lu-177-ITG-PSMA-1 treatment, compared to base-line.
Tumor evaluation using contrast enhanced computed tomography (ceCT)	Tumor evaluation using contrast enhanced computed tomography (ceCT) using RECIST v1.1 (change in tumor size in mm)	four weeks after the second cycle of Lu-177-ITG-PSMA-1 treatment, compared to base-line.

Collaborators and Investigators

• Sponsor: John O. Prior
• Investigators: Principal Investigator: John O Prior, PhD MD, Centre Hospitalier Universitaire Vaudois - Lausanne University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2023
• Primary Completion (Actual): April 9, 2024
• Study Completion (Actual): April 30, 2024

Study Registration Dates

• First Submitted: June 11, 2022
• First Submitted That Met QC Criteria: June 11, 2022
• First Posted (Actual): June 15, 2022

Study Record Updates

• Last Update Posted (Actual): June 18, 2024
• Last Update Submitted That Met QC Criteria: June 17, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma; Molecular Mechanisms of Pharmacological Action; Radiopharmaceuticals; Gallium 68 PSMA-11
• Other Study ID Numbers: Theranostics STS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No