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Cabazitaxel in Combination With 177Lu-PSMA-617 in Metastatic Castration-resistant Prostate Cancer

NCT05340374•Peter MacCallum Cancer Centre, Australia

Summary

This clinical trial will evaluate the safety of Cabazitaxel in combination with 177Lu-PSMA-617 in metastatic castration-resistant prostate cancer.

Detailed Description

This prospective, single-centre, single-arm, open label, phase I/II trial will assess the safety, efficacy and anti-tumour activity of cabazitaxel in combination with 177Lu-PSMA-617 in patients with metastatic castration-resistant prostate cancer (mCRPC). This study aims to assess and establish the maximum tolerated dose (MTD), dose-limiting toxicities (DLTs), and recommended phase 2 dose (RP2D) of cabazitaxel in combination with 177Lu-PSMA-617 in patients with mCRPC. 32-44 men with mCRPC who have progressed on prior docetaxel and a second-generation AR antagonist will be enrolled in this trial in two stages: dose escalation and a dose expansion phase over a period of 18 months.

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•1. Male patients aged 18 years or older at the time of informed consent.
•2. Patient has provided written informed consent.
•3. Histologically confirmed adenocarcinoma of the prostate without neuroendocrine or small cell differentiation.
•4. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
•5. Patients must have had prior treatment with docetaxel.
•6. Patients must have progressed on a second-generation androgen receptor (AR)-targeted agent (e.g., enzalutamide, abiraterone, or apalutamide) in the castrate-resistant setting.
•7. Patients must have progressive disease. The Prostate Cancer Clinical Trials Working Group 3 (PCWG3) defines this as any one of the following:
•1. PSA progression: minimum of two rising PSA values from a baseline measurement with an interval of ≥ 1 week between each measurement
•2. Soft tissue or visceral disease progression as per Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1) criteria
•3. Bone progression: ≥ 2 new lesions on bone scan
+17 more criteria

Exclusion Criteria

•1. Superscan on WBBS or diffuse marrow disease on PSMA PET.
•2. Site(s) of measurable disease that are FDG-positive with low PSMA expression (SUVmax \<10).
•3. Prior treatment with cabazitaxel or 177Lu-PSMA-617.
•4. Contraindications to the use of corticosteroid treatment.
•5. Other malignancies within the previous 2-years other than basal cell or squamous cell carcinomas of skin or other cancers that are unlikely to recur within 24 months.
•6. Presence of untreated brain metastases or leptomeningeal metastases.
•7. Patients with symptomatic or impending cord compression unless appropriately treated beforehand and clinically stable for ≥ four weeks.
•8. Concurrent illness, including severe infection that may jeopardise the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety.
•9. Persistent toxicities (CTCAE v5.0 \>/= Grade 2) caused by previous cancer therapy, excluding alopecia.
•10. Known HIV or hepatitis B or C infection.
+1 more criteria

Locations (2)

St Vincent's Hospital

Sydney, New South Wales, Australia

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

Key Dates

Start Date

July 14, 2022

Primary Completion Date

June 20, 2026

Completion Date

December 1, 2026

Last Updated

April 6, 2025

Enrollment

ACTUAL participants

Conditions

Metastatic Castration-resistant Prostate CancermCRPC

Interventions

Cabazitaxel

DRUG

177Lu-PSMA-617

DRUG

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

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RECRUITINGPHASE2

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 6, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Cabazitaxel in Combination With 177Lu-PSMA-617 in Metastatic Castration-resistant Prostate Cancer

Inclusion Criteria

Exclusion Criteria

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

Phase 2a Study of High-Dose Testosterone Followed by Radioligand Therapy in mCRPC

AB-3028, a Programmable Circuit T Cell Therapy in Patients With Castration Resistant Prostate Cancer (CRPC)

A Clinical Study of KTX-2001 in Subjects With Metastatic Castration-Resistant Prostate Cancer (STRIKE-001)

SHR-1701 in Combination With Stereotactic Body Radiotherapy in mCRPC