Lutetium (177Lu) DGUL Combined With Pembrolizumab in Metastatic Castration-Resistant Prostate Cancer

ConditionMetastatic Castration-resistant Prostate Cancer (mCRPC)

Trial statusRecruiting

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

Lutetium (177Lu) DGUL
Drug
Lutetium (177Lu) DGUL will be administered in 4 doses at 6-week intervals (Q6W), and for patients showing good tolerance, additional 2 doses may be added, for a maximum of 6 doses.
Pembrolizumab
Drug
pembrolizumab will be introduced at a dose of 400 mg every 6 weeks, beginning with the second cycle of Lutetium (177Lu) DGUL, and will continue for up to approximately 2 years (18 doses).

Treatment groups

30 Participants

are divided into 2 treatment groups

Group A: Monotherapy ArmExperimental treatment 1 intervention

Group B: Combination ArmExperimental treatment 2 interventions