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Expanded Access Treatment With [Lu-177]-PNT2002 for Adult Patients With Prostate-Specific Membrane Antigen (PSMA)-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC)

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ClinicalTrials.gov Identifier: NCT06033001
Expanded Access Status : Available
First Posted : September 13, 2023
Last Update Posted : February 26, 2024
Sponsor:
Collaborator:
POINT Biopharma, a wholly owned subsidiary of Eli Lilly and Company
Information provided by (Responsible Party):
Lantheus Medical Imaging

Brief Summary:

The purpose of this program is to provide access to [Lu-177]-PNT2002 to patients who have been diagnosed with prostate-specific membrane antigen (PMSA)-positive castration-resistant prostate cancer (mCRPC). Patients must have received at least 1 prior androgen pathway inhibitor (ARPI) and cannot be treated by currently available drugs or clinical trials.

In this program participants will be administered [Lu-177]-PNT2002 intravenously every 8 weeks (about every 2 months) for 4 cycles, or 8 months of total treatment. During treatment, participants will be monitored with routine laboratory tests such as:

  • Hematology blood tests
  • Clinical Chemistry blood tests
  • Testosterone/Prostate Antigen levels blood test
  • Vital signs
  • Imaging
  • ECG

Condition or disease Intervention/treatment
Castration-Resistant Prostatic Cancer Drug: [Lu-177]-PNT2002

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Study Type : Expanded Access
Expanded Access Type : Intermediate-size Population
Official Title: Expanded Access Treatment With [Lu-177]-PNT2002 for Adult Patients With Prostate-Specific Membrane Antigen (PSMA)-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer


Intervention Details:
  • Drug: [Lu-177]-PNT2002
    [Lu-177]-PNT2002, is a radiopharmaceutical investigational drug. [Lu-177]-PNT2002 targets a specific protein that is located on the surface of prostate cancer cells called PSMA. [Lu-177]-PNT2002 delivers radiation to your cancer by binding to the PSMA which helps destroy the cancer cells. [Lu-177]-PNT2002 is administered intravenously every 8 weeks (about every 2 months) for 4 cycles, or 8 months of total treatment.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Criteria

Inclusion Criteria:

  1. Patient is male aged 18 years or older;
  2. Histological, pathological, and/or cytological confirmation of adenocarcinoma of the prostate;
  3. Patients must have at least 1 metastatic lesion present on CT, MRI, or bone scan imaging;
  4. Patients must have progressive mCRPC based on at least 1 of the following criteria:

    1. Serum/plasma PSA progression defined as increase in PSA greater than 25% and >2 ng/mL above nadir, confirmed by progression at 2 time points at least 3 weeks apart
    2. Soft-tissue progression defined as an increase ≥20% in the sum of the diameters (SOD) (short axis for nodal lesions and long axis for non-nodal lesions) of all target lesions based on the smallest SOD since treatment started or the appearance of one or a new lesion
    3. Progression of bone disease defined as the appearance of 2 or more lesions by bone scan
  5. Progression on prior treatment with ≥1 ARPI (abiraterone, apalutamide, darolutamide, enzalutamide ) in nmCRPC, mHSPC or mCRPC;
  6. PSMA-PET scan ([Ga-68]-PSMA-11 or [F-18]-DCFPyL) positive as determined by local investigator;

    1. At least 1 PSMA-PET positive lesion for prostate cancer
    2. Uptake greater than the liver will be used as the reference for determining PSMA-PET positivity and uptake less than or equal to the liver will be used as the reference for determining PSMA-PET negativity
    3. All lymph nodes that measure ≥25 mm in short axis on anatomic imaging must be PSMA-PET positive
    4. All bone metastases with soft tissue component(s) ≥10 mm in short axis must be PSMA-PET positive (PSMA-negative osseous metastases without a soft tissue component do not exclude patients)
    5. All solid organ metastases (i.e., lung, liver, adrenal glands, etc.) ≥10 mm in short axis must be PSMA-PET positive
  7. Castrate levels of circulating testosterone (<1.7 nmol/L or <50 ng/dL);
  8. Patients must have recovered to Grade ≤2 from all clinically significant toxicities related to; prior therapies (i.e., prior ARPI, chemotherapy, PARPi, radioisotope or immunotherapy, etc.)
  9. Adequate organ function, independent of transfusion;

    a. Bone marrow reserve

    i. White blood cell (WBC) count ≥2.5 x 109/L OR absolute neutrophil count (ANC) ≥1.5 x 109/L ii. Platelets ≥100 x 109/L iii. Hemoglobin ≥80 g/L or ≥8 g/dL

    b. Liver function

    i. Total bilirubin ≤1.5 x institutional upper limit of normal (ULN). For patients with known Gilbert's syndrome, ≤3.0 x ULN ii. ALT and AST ≤3.0 x ULN

    c. Renal function

    i. Creatinine clearance ≥50 mL/min based on Cockroft-Gault formula

    d. Albumin ≥30 g/L

  10. Human immunodeficiency virus-infected patients who are healthy and have a low risk of acquired immunodeficiency syndrome-related outcomes are eligible;
  11. ECOG performance status 0 or 1;
  12. For patients who have partners who are pregnant or of childbearing potential: a condom is required along with a highly effective contraceptive method during the study and for 6 months after last study drug administration. Such methods deemed highly effective include a) combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation, b) progestogen-only hormonal contraception associated with inhibition of ovulation, c) intrauterine device (IUD), d) intrauterine hormone-releasing system (IUS), e) bilateral tubal occlusion, f) vasectomy, g) true sexual abstinence: when this is in line with the preferred and usual lifestyle of the subject [periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods), declaration of abstinence for the duration of exposure to IMP, and withdrawal are not acceptable methods of abstinence].
  13. Signed Informed Consent Form

Exclusion Criteria:

  1. Prior PSMA-targeted radioligand therapy (i.e., [Lu-177]-PSMA-617);
  2. A superscan defined as a bone scan that demonstrates markedly increased skeletal radioisotope uptake relative to soft tissues in association with absent or faint genitourinary tract activity;
  3. Patients with a history of central nervous system (CNS) metastases must have received therapy (surgery, radiotherapy, gamma knife) and be neurologically stable, asymptomatic, and not receiving corticosteroids for the purposes of maintaining neurologic integrity;
  4. Patients with epidural disease, canal disease and prior cord involvement are eligible if those areas have been treated, are stable, and not neurologically impaired. For patients with parenchymal CNS metastasis (or a history or CNS metastasis), baseline and subsequent radiological imaging must include evaluation of the brain (MRI preferred or CT with contrast);
  5. Symptomatic cord compression, or clinical radiologic findings indicative of impending cord compression;
  6. Any pre-existing symptoms, or concurrent severe and/or uncontrolled medical conditions such as ureteral obstruction, which in the opinion of the investigator would compromise safe participation in the [Lu-177]-PNT2002 EAP;
  7. Not able to understand and comply with treatment instructions and requirements;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06033001


Contacts
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Contact: Associate Director Radioligand Clinical Applications 901-283-5950 LNTH-PNT2002-EAP-INFO@lantheus.com

Locations
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United States, California
Hoag Memorial Hospital Presbyterian Available
Newport Beach, California, United States, 92663
United States, Florida
Florida Theranostics Cancer Center Available
Jupiter, Florida, United States, 33458
United States, Michigan
BAMF Health, Inc Available
Grand Rapids, Michigan, United States, 49503
Sponsors and Collaborators
Lantheus Medical Imaging
POINT Biopharma, a wholly owned subsidiary of Eli Lilly and Company
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Responsible Party: Lantheus Medical Imaging
ClinicalTrials.gov Identifier: NCT06033001    
Other Study ID Numbers: LNTH-PNT2002-EAP01
First Posted: September 13, 2023    Key Record Dates
Last Update Posted: February 26, 2024
Last Verified: February 2024
Keywords provided by Lantheus Medical Imaging:
progressive mCRPC
Additional relevant MeSH terms:
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Prostatic Neoplasms
Prostatic Neoplasms, Castration-Resistant
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases