Phase Ib Trial of 177Lu-PSMA-I&T Therapy in Combination With Olaparib and Pembrolizumab in Patients With Metastatic Castration Resistant Prostate Cancer

Sponsor
Peter MacCallum Cancer Centre, Australia
Study ID
NCT07090369
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Metastatic Castrate Resistant Prostate Cancer (mCRPC)

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Olaparib (300 mg BID) — DRUG
    oral tablet
  • Pembrolizumab — DRUG
    IV infusion
  • 177Lu-PSMA-I&T — RADIATION
    PSMA-I\&T is a small molecule ligand that binds to the extra-cellular domain of the prostatespecific membrane antigen. PSMA-I\&T is a small molecule ligand that binds to the extra-cellular domain of the prostatespecific membrane antigen

Study Details

This phase 1b trial is designed to evaluate the safety and tolerability of olaparib in combination with 177Lutetium-Prostate Specific Membrane Antigen (177 Lu-PSMA) and pembrolizumab in patients with metastatic castration resistant prostate cancer (mCRPC).

Key Dates

Start date
Nov 1, 2025
Status verified
Feb 2025
Primary completion
Dec 1, 2028
Completion
Dec 1, 2028

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 177Lu-PSMA + olaparib + pembrolizumab
    Patients will receive treatment in two parts. A cycle in both parts is 42 days. In part 1, patients will receive a combination of olaparib (oral; days 1-22), a fixed 7.4 GBq dose of 177Lu-PSMA (IV infusion; day 5) and pembrolizumab (IV infusion; days 1 and 22). In part 2, patients will be administered with single agent pembrolizumab (IV infusion; days 1 and 22) for an additional 12 cycles of treatment.

Primary Outcome Measure

Progression Free Survival [ Time Frame: 24 months from recruitment of last patient ]

Central Contacts