Cancer Research in HKUMed
7. Genitourinary

7.0 Genitourinary

7.1 Clinical Trial

7.1.1 Kidney

Study Title

Key Eligibility Criteria

Investigational Product

Principal Investigator

Department

Email

Contact number

Protocol ID: MK-6482-033:

A Phase 3, Randomized, Open-label Study of Belzutifan + Zanzalintinib Versus Cabozantinib for the Treatment of Participants with Locally Advanced or Metastatic RCC who Experienced Disease Recurrence During or After Prior Adjuvant Anti-PD-1/L1 Therapy (LITESPARK-033)

· Advanced RCC with clear cell

· Disease recurrence per RECIST v1.1

· Disease recurrence during/following prior adjuvant anti-PD-1/L1 (<24 months from last dose)

· No other prior treatment for metastatic RCC

Belzutifan + Zanzalintinib

VS

Cabozantinib

Dr. Bryan Li

Centre of Cancer Medicine

cancermed@hku.hk

3910 3339

7.1.3 Prostate

Study Title

Key Eligibility Criteria

Investigational Product

Principal Investigator

Department

Email

Contact number

Protocol ID: MK-2400-001:

A Phase 3, Open-label Study of Ifinatamab Deruxtecan Versus Docetaxel in Participants with Metastatic Castration-Resistant Prostate Cancer (mCRPC) (IDeate-Prostate01)

· Failed 1 or 2 prior ARPI for nmHSPC, mHSPC, nmCRPC or mCRPC

· Docetaxel for HSPC allowed if no radiographic progression within 1 year after last dose

· Prior taxane chemotherapy for mCRPC not allowed

Ifinatamab Deruxtecan

VS.

Docetaxel

Dr. Bryan Li

Centre of Cancer Medicine

cancermed@hku.hk

3910 3339

Study Title

Key Eligibility Criteria

Investigational Product

Principal Investigator

Department

Email

Contact number

CAPItello-281 (Protocol ID: D361BC00001):

A Phase III Double-Blind, Randomized, Placebo-Controlled Study Assessing the Efficacy and Safety of Capivasertib + Abiraterone Versus Placebo + Abiraterone as Treatment for Patients with De Novo Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) Characterized by PTEN deficiency.

· Histologically diagnosed prostate adenocarcinoma.

· Distant metastatic disease.

· No prior pharmacotherapy, radiation therapy or surgery.

· PTEN deficiency status

Capivasertib (Akt inhibitor)

+ Abiraterone (Androgen biosynthesis inhibitors)

Vs.

Placebo + Abiraterone

Dr. Steven Wai Kwan Siu

Department of Clinical Oncology

oncology@hku.hk

Cliff CHONG

2255 5102

Study Title

Key Eligibility Criteria

Investigational Product

Principal Investigator

Department

Email

Contact number

PSMAddition (Protocol ID: CAAA617C12301):

An Open-label, Randomized, Phase III Study Comparing 177Lu-PSMA-617 in Combination With Standard of Care, Versus Standard of Care Alone, in Adult Male Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC).

· Metastatic Hormone-Sensitive Prostate Cancer (mHSPC).

· Metastatic prostate cancer with histologically or cytologically confirmed adenocarcinoma.

· Evidence of PSMA-positive disease.

· Treatment naïve.

177 Lu-PSMA-617 (Radioconjugate)

+ SOC

Vs.

SOC

Dr. Steven Wai Kwan Siu

Department of Clinical Oncology

oncology@hku.hk

Cliff CHONG

2255 5102

Study Title

Key Eligibility Criteria

Investigational Product

Principal Investigator

Department

Email

Contact number

Protocol ID: 20230005:

A Phase 3, Open-label, Multicenter, Randomized Study of Xaluritamig vs Cabazitaxel or Second Androgen Receptor-Directed Therapy in Subjects With Metastatic Castration-Resistant Prostate Cancer Previously Treated With Chemotherapy

· At least one prior ADRT treatment

· One prior taxane therapy

· No more than one prior chemo under castration-resistant setting

· No prior STEAP-1-targeted therapy

· No CNS metastasis

· No radionuclide (Radium-223) within 2 months prior to start of study treatment

Xaluritamig

Vs.

Cabazitaxel or second ADRT of physician’s choice

Dr. Bryan Li

Centre of Cancer Medicine

cancermed@hku.hk

3910 3339

Study Title

Key Eligibility Criteria

Investigational Product

Principal Investigator

Department

Email

Contact number

Protocol ID: 20230239:

A Phase 3, Open-label, Multicenter, Randomized Study of Xaluritamig Plus Abiraterone Versus Investigator’s Choice in Participants with Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer

· evidence of disease progression.

· disease progression on one and only one androgen receptor pathway inhibitor.

· Participants intended to receive cabazitaxel must have previously received ≤ 6 cycles of docetaxel in the mHSPC setting.

Xaluritamig + Abiraterone

Vs.

Cabazitaxel or Docetaxel or Abiraterone

Dr. Bryan Li

Centre of Cancer Medicine

cancermed@hku.hk

3910 3339

Study Title

Key Eligibility Criteria

Investigational Product

Principal Investigator

Department

Email

Contact number

Protocol ID: CAAA817B12301:

AcTFirst: A phase III, open-label, multi-center, randomized study comparing AAA817+ARPI versus standard of care in adult participants with PSMA-positive metastatic castration resistant prostate cancer (CAAA817B12301)

· Progressive disease while on treatment with nmHSPC or earlier setting as their last treatment (more than 1 ARPI)

· Taxane-naive in mCRPC setting (allowed in nmHSPC)

· ≥ 1 PSMA-positive metastatic lesion on PSMA PET/CT using an approved PSMA imaging agent, and eligible as determined by the sponsor's central reading rules

· Participants with known or suspected hereditary germline or somatic homologous recombination repair (HRR) gene mutations are excluded

AAA817

Vs.

ARPI (Enzalutamide or Abiraterone) OR

Taxane-based chemotherapy (docetaxel or cabazitaxel)

Dr. Matthew Chiu

Department of Clinical Oncology

cancermed@hku.hk

3910 3339

Study Title

Key Eligibility Criteria

Investigational Product

Principal Investigator

Department

Email

Contact number

Protocol ID: CDZR123C12101:

A two-part Phase I dose escalation study of Tulmimetostat (DZR123) in combination with darolutamide or abiraterone followed by open-label, randomized, Phase II dose expansion study to assess the safety and efficacy of Tulmimetostat in combination with darolutamide versus darolutamide alone in patients with metastatic hormone-sensitive prostate cancer

· Confirmed adenocarcinoma of the prostate without neuroendocrine or small cell features.

· Participants must have de novo or recurrent mHSPC with at least one documented metastatic lesion.

Tulmimetostat + Darolutamide

Vs.

Darolutamide

Dr. Bryan Li

Centre of Cancer Medicine

cancermed@hku.hk

3910 3339