A dosimetry study of lutetium (177Lu) rhPSMA-10.1 and lutetium (177Lu) vipivotide tetraxetan (Pluvicto®) in patients with non-curative metastatic prostate cancer

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Blue Earth Therapeutics Limited

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

15 Apr 2025 → 15 Aug 2025

Decision date (initial)

2025-03-03

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Blue Earth Therapeutics Limited

External identifiers

EU CT number

2024-515264-31-00

WHO UTN

U1111-1309-4444

ClinicalTrials.gov

NCT06516510

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others, Safety

To compare the therapeutic index of lutetium (177Lu) rhPSMA-10.1 and lutetium (177Lu) vipivotide tetraxetan.

Secondary objectives 3

1. 1. To compare the absorbed dose of lutetium (177Lu) rhPSMA-10.1 and lutetium (177Lu) vipivotide tetraxetan to tumour lesions and organs of interest.
2. 2. To compare the tumour and normal organ effective half-lives of lutetium (177Lu) rhPSMA-10.1 and lutetium (177Lu) vipivotide tetraxetan.
3. 3. To further evaluate the safety profile of lutetium (177Lu) rhPSMA-10.1 injection.

Conditions and MedDRA coding

PSMA-positive non-curative metastatic castration-resistant prostate cancer

Regulatory references

EMA paediatric investigation plan (PIP)

EMEA-003353-PIP01-22

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. 1. Male patient aged ≥60 years old at Visit 1 (Screening)
2. 2. Patient has non-curative PSMA-positive prostate cancer that has spread outside of the prostate gland and is undergoing, has undergone, or is being planned for systemic therapy.
3. 3. At least 1 PSMA-positive lesion that can be outlined on PET or CT and ≥1 cm in the short axis measured on either modality, for the purpose of dosimetry.
4. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
5. 5. Adequate normal organ function.
6. 6. Willing to provide signed and dated written informed consent form (ICF) prior to any study-specific procedures.
7. 7. Male patients must agree not to father children or donate sperm during the study and for at least 14 weeks after the last study treatment. In addition, they must agree to use effective contraception for this same period to protect partners from any exposure to the investigational products.

Exclusion criteria 8

1. 1. Known hypersensitivity to lutetium (177Lu) rhPSMA-10.1 or lutetium (177Lu) vipivotide tetraxetan, or any of the constituents.
2. 2. Previous treatment with any radiopharmaceutical therapy in the 42 days or 5 physical half-lives (whichever is longer) prior to Visit 1 (Screening).
3. 3. Any significant metallic implants or objects, which may in the opinion of the investigator, affect image quality and/or dosimetry calculations.
4. 4. Severe claustrophobia, inability to lie flat or fit into the scanner, or any other inability to tolerate the SPECT/CT scan protocol.
5. 5. Any change to prostate cancer medication, initiation of other prostate cancer therapy (e.g. radiotherapy), or prostate cancer surgical procedure within 42 days prior to screening and/or during study participation.
6. 6. For any patients receiving androgen deprivation therapy (ADT), any change in dose in the last 8 weeks prior to Visit 1 (Screening) will make them ineligible for the study.
7. 7. Any medical or psychiatric condition, including rapidly progressive prostate cancer, that in the investigator’s judgement, makes the patient ineligible for the study.
8. 8. Participation in other studies involving other IMPs within 42 days or 5 half-lives (whichever is longer) prior to Visit 1 (Screening) and/or during study participation.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 1. The primary endpoint of the study is the ratio of tumour to kidney absorbed dose ratios (i.e. the ratio of the therapeutic indices).

Secondary endpoints 5

1. 1. The absorbed dose delivered to the tumours for lutetium (177Lu) rhPSMA-10.1 compared with lutetium (177Lu) vipivotide tetraxetan.
2. 2. The ratio of tumour to normal organ absorbed dose ratios. Organs of interest include the salivary glands and bone marrow.
3. 3. Tumour retention of lutetium (177Lu) rhPSMA-10.1 compared with lutetium (177Lu) vipivotide tetraxetan. Note: Retention will be measured as the tumour effective half-life.
4. 4. Normal organ retention of lutetium (177Lu) rhPSMA-10.1 compared with lutetium (177Lu) vipivotide tetraxetan. Note: Retention will be measured as the normal organ effective half-life.
5. 5. Frequency and nature of treatment-emergent adverse events (TEAEs).

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Blue Earth Therapeutics Limited

Sponsor organisation

Blue Earth Therapeutics Limited

Address

The Oxford Science Park, Magdalen Centre, 1 Robert Robinson Avenue Magdalen Centre 1 Robert Robinson Avenue

City

Oxford

Postcode

OX4 4GA

Country

United Kingdom

Scientific contact point

Organisation

Blue Earth Therapeutics Limited

Contact name

Regulatory Submissions

Public contact point

Organisation

Blue Earth Therapeutics Limited

Contact name

Regulatory Submissions

Third parties 2

Locations

4 EU/EEA countries · 11 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Application history

2 submissions — initial application plus substantial / non-substantial modifications