XCancer

A Phase 3 Study of [177Lu]Ludotadipep for Metastatic Castration-Resistant Prostate Cancer

Description:

Primary Efficacy Endpoint \- Radiographic Progression-Free Survival (rPFS): rPFS is defined as the time from randomization to radiographic disease progression (PD), as assessed by Blinded Independent Central Review (BICR) according to PCWG3-modified RECIST version 1.1, or death from any cause, whichever occurs first. rPFS will be analyzed using the Kaplan-Meier method. The median survival time and corresponding two-sided 95% confidence intervals (CIs) will be estimated for both the investigational and control arms, and Kaplan-Meier curves will be presented. A comparison between the investigational and control arms will be performed using a stratified Cox proportional hazards regression model. The model will be adjusted for the following stratification factors: nomogram score (≥178 vs \<178), ECOG Performance Status (0 or 1 vs 2), prior use of cabazitaxel before randomization (yes vs no), and receipt of best supportive care alone (yes vs no). The p-value will be reported. Ties in event times will be handled using the Efron method. The hazard ratio (HR) of the investigational arm relative to the control arm and its corresponding two-sided 95% confidence interval will be provided.

Sponsor:

FutureChem

Phase:

Phase 3

Contacts:

Ji Youl Lee (PRINCIPAL_INVESTIGATOR)

Chan Soo Park (CONTACT)

chansoo.park@futurechem.co.kr

+82 70 5066 2479

Government Study Link:

NCT07853209 - Click here to see study on

ClinicalTrials.gov

Ludotadipep

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Small Molecules
Chelator: DOTA
Inclusion
  • Planned best supportive care/standard of care (BSC/SoC) must be permitted in this study, and both investigator and patient agree that disease management with BSC/SoC alone is appropriate.
  • Patients with progressive metastatic castration-resistant prostate cancer (mCRPC) meeting at least one of the following criteria:
  • PSA progression: Minimum PSA level of ≥2.0 ng/mL with at least two consecutive increases at intervals of ≥1 week.
  • Histologically, pathologically, or cytologically confirmed prostate adenocarcinoma without small cell features.
  • At least one, but no more than two, prior taxane regimens. Patients who have not received docetaxel may be enrolled if deemed unsuitable, refused treatment, or lack access.
  • COG performance status ≤2.
  • At least one novel anti-androgen drug (NAAD) (e.g., enzalutamide and/or abiraterone). (First-generation anti-androgens such as bicalutamide, flutamide, and nilutamide are not counted.)
  • No PSMA-negative lesions∥. ∥Defined as metastatic lesions with uptake equal to or lower than liver background and measurable on CT¶.
  • At least one PSMA-positive metastatic lesion§. §Defined as uptake greater than liver background, regardless of organ system or lesion size.
  • At least one metastatic lesion documented by CT, MRI, or bone scan within 4 weeks prior to baseline.
  • i. Bone lesions with soft tissue component ≥1 cm (short axis) ii. Solid organ metastases ≥1 cm (short axis) iii. Lymph nodes ≥2.5 cm (short axis)
  • PSMA-positive mCRPC confirmed by \[18F\]PSMA PET/CT at screening by independent central review, meeting all of the following:
  • Soft tissue progression: i. ≥20% increase in the sum of diameters (SOD)\* of target lesions compared to the smallest SOD since treatment initiation, or ii. Appearance of one or more new lesions. \*Short axis for lymph nodes and long axis for non-nodal lesions. (c) Bone progression: Appearance of ≥2 new lesions on bone scan.
Exclusion
  • PSMA-targeted radioligand therapy
  • Prior treatment with any of the following therapies:
  • Any other anticancer therapy (including cytotoxic chemotherapy, immunotherapy, biologic therapy, or targeted therapy) within 4 weeks prior to randomization
  • Immunocompromised status (including splenectomy or hematopoietic stem cell transplantation) or active autoimmune disease (e.g., myasthenia gravis, Hashimoto's thyroiditis, rheumatoid arthritis, multiple sclerosis, systemic lupus erythematosus, scleroderma)
  • Presence of any of the following comorbidities:
  • Severe infection or other uncontrolled active infection that may interfere with study assessments, as judged by the investigator
  • Presence of a superscan on bone scan at baseline.
  • Systemic radionuclide therapy within 24 weeks prior to the first dose of study intervention (e.g., strontium-89, samarium-153, rhenium-186, rhenium-188, radium-223, or hemi-body irradiation)
  • Clinically significant cardiovascular disease within 24 weeks prior to screening, including but not limited to: i. Myocardial infarction or severe/unstable angina ii. Congestive heart failure (NYHA Class III or IV) iii. QTcF \>480 msec on ECG iv. Clinically significant seizures or conditions predisposing to seizures v. Symptomatic or impending spinal cord compression (d) Known human immunodeficiency virus (HIV) infection