[Lu-177]Ludotadipep in Castration-resistant Prostate Cancer(CRPC): Investigation of Drug and Application

Status unconfirmed · Phase 1/Phase 2

Conditions studied: Metastatic Castration-resistant Prostate Cancer

In brief

Phase 1: The objective of the Phase 1 part of the clinical trial is to verify safety and tolerability (dose-limiting toxicity \[DLT\], maximum tolerated dose \[MTD\]) of a single 3.7 Giga-Becquerel (GBq) dose with the potential for one dose level de-escalation to 2.775 GBq if necessary, to determine the recommended \[177Lu\]Ludotadipep dose for use in the Phase 2a part of the trial. Phase 2a: The objective of the Phase 2a part of the trial is to evaluate safety and efficacy for repeated administration of the recommended \[177Lu\]Ludotadipep dose. The Recommended Phase 2 dose (RP2D) will be based on the study results from the Phase 1 trial in South Korea upon consultation with the FDA.

Key facts

Study ID: NCT05458544
Run by: FutureChem
People needed: 26
Starts: 2022-09-01
Expected to finish: 2025-06-01
Last updated by the study team: 2024-04-29

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

Patients must meet the following criteria in order to be included in both the Phase 1 and Phase 2a parts of the trial:
Male and ≥ 18 years
Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features at initial diagnosis
Disease progression on any one of the following: prior enzalutamide, abiraterone, apalutamide or related agent therapy as defined by meeting at least one of the following criteria per the investigator in accordance with the Prostate Cancer Working Group 3 (PCWG3) criteria [Scher et al, 2016]:
PSA progression as defined by a minimum of two rising PSA levels at least 1 week apart, ideally three successive measurements
Soft tissue disease progression defined as >20% increase in sum of diameters of all target lesions based on sum of diameters since treatment started or the appearance of 1 or more new lesions by RECIST 1.1
Bone disease progression defined by two or more new lesions on bone scan
Serum testosterone level < 50 ng/dL (< 0.5 ng/mL, < 1.7 nmol/L). Patients may have ongoing androgen deprivation therapy (ADT) with a luteinizing hormone-releasing hormone (LHRH) "super-agonist" or antagonist, and/or be surgically or medically castrated.
Patients must have PSMA positive lesions. These are defined as having Ga 68-PSMA-11 uptake greater than that of liver parenchyma in one or more metastatic lesions of any size in any organ system. PSMA-negative lesions are defined as having PSMA uptake equal to or lower than that of liver parenchyma in any lymph node with a short axis of at least 2.5 cm, in any metastatic solid-organ lesions with a short axis of at least 1.0 cm, or in any metastatic bone lesion with a soft-tissue component of at least 1.0 cm in the short axis.
Patients receiving bisphosphonate therapy must have been on stable doses for at least 4 weeks prior to Day 1
Patients who have received a taxane or are ineligible or choose not to receive taxane-based chemotherapy based on personal preference or physician opinion. Examples of conditions that could make a patient ineligible or refuse to receive taxane-based chemotherapy include the following:
Poor performance status
Prior intolerance to cytotoxic agents
Other serious medical conditions such as symptomatic peripheral neuropathy Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 or higher; or clinically significant cardiovascular disease per the Investigator
ECOG PS of 0 to 2 for Phase 1 and 0 to 1 for Phase 2a
Estimated life expectancy of at least 3 months for Phase 1 and 6 months for Phase 2a as determined by the Investigator.
For patients who have partners of childbearing potential, the partner and/or patient must use a method of birth control with adequate barrier protection, deemed acceptable by the principal investigator during the study and for 3 months after last study drug administration.
Able and willing to provide signed informed consent and comply with protocol requirements

You may not qualify if…

Patients will be excluded from the study if they meet any of the following criteria (applies to both Phase 1 and Phase 2a):
Impaired organ function as evidenced by the following laboratory values at Screening:
Absolute neutrophil count < 1500/μL
Platelet count < 100,000/μL
Hemoglobin < 9.0 g/dL Note: the patient cannot have received blood transfusion or growth factor support in the 2 weeks prior to screening laboratory hematology assessments.
Albumin < 3.0 g/dL (30 g/L)
Total bilirubin > 2 x upper limit of normal (ULN) unless in instances of known or suspected Gilbert's disease
aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 x ULN
Calculated creatinine clearance < 60 mL/min (Cockroft-Gault equation), or currently on renal dialysis
QT interval corrected for heart rate (QTcF) > 470 msec
Sjogren's syndrome
Known or suspected brain metastasis or active leptomeningeal disease
History of other malignancy within the previous 3 years, except basal cell or squamous cell carcinoma, or non-muscle invasive bladder cancer
History of active thromboembolism within the last 3 months of Day 1
Serious persistent infection within 14 days prior to Day 1
If the patient is known to have a positive polymerase chain reaction (PCR) test for active COVID-19 infection or signs or symptoms consistent with COVID-19, in the absence of a positive PCR test, within 5 days from date of consent
Patients with any medical condition or other circumstances that, in the opinion of the investigator, compromise obtaining reliable data, achieving study objectives, or completing the study
History of congestive heart failure New York Heart Association (NYHA) class III or IV, uncontrolled hypertension or evidence of coronary artery disease (including a myocardial infarction) within the previous 6 months from date of consent
Patients who received any anti-tumor therapy within 4 weeks of Day 1, with the exception of abiraterone, enzalutamide or apalutamide, GnRH therapy and non-radioactive bone-targeted agents
Superscan as evidenced on baseline bone scan
Treatment with Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223 within 6 months prior to Day 1
Prior hemi-body irradiation
Prior PSMA-targeted radioligand therapy
Major surgery within 4 weeks of Day 1
Prior systemic beta-emitting bone-seeking radioisotopes

Where it is running

VA Greater Los Angeles Healthcare System,Cancer Center Research — Los Angeles, California, United States (enrolling)
Pennsylvania Cancer Specialists & Research Institute (Formerly Gettysburg Cancer Center) — Gettysburg, Pennsylvania, United States (enrolling)
University of Maryland — Baltimore, Maryland, United States
Chesapeake Urology Research Associates — Towson, Maryland, United States

Full record on ClinicalTrials.gov

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