Lutetium (177Lu) DGUL Combined With Pembrolizumab in Metastatic Castration-Resistant Prostate Cancer
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age19+
SponsorCellbion Co., Ltd.
About this trial
The goal of this clinical trial is to evaluate the safety of the combination therapy of Lutetium (177Lu) DGUL and pembrolizumab. It will also assess the antitumor efficacy and pharmacokinetics of the combination therapy compared to Lutetium (177Lu) DGUL monotherapy.
Participants will:
Monotherapy: Receive Lutetium (177Lu) DGUL 4 times (plus 2 additional doses) at 6-week intervals
Combination therapy: Receive Lutetium (177Lu) DGUL 4 times (plus 2 additional doses) at 6-week intervals along with pembrolizumab up to 18 times at 6-week intervals
Eligibility criteria
Qualifiers
Male patients aged 19 years or older.
Patients with histopathologically or cytologically confirmed adenocarcinoma of the prostate, without neuroendocrine or small cell differentiation, who have metastatic disease documented by bone lesions/soft tissue lesions and are not eligible for curative treatment.
Patients with serum testosterone levels meeting castration levels (< 50 ng/dL) at the screening visit.
Patients must have experienced disease progression following treatment for mCRPC with a second-generation androgen receptor signaling inhibitor therapy (e.g., abiraterone or enzalutamide).
Disqualifiers
Known additional malignancy that is progressing or has required active treatment within the past 3 years (Patients with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ, excluding carcinoma in situ of the bladder, that have undergone potentially curative therapy are not excluded).
Patients who have received chemotherapy, biological therapy, or immunotherapy for prostate cancer within 4 weeks from baseline (6 weeks in the case of nitrosoureas or mitomycin).
Any prior treatment with taxane chemotherapy for mCRPC.
Patients with history of allogeneic stem cell transplantation (alloSCT), or solid organ transplantation.
Trial design
Treatments tested in this trial
- Lutetium (177Lu) DGUL
- Pembrolizumab
Treatment groups
30 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Cellbion Co., Ltd.
Lead sponsor
Merck Sharp & Dohme LLC
Collaborator
Source ClinicalTrials.gov