Phase 2 trial of ARPI to AR-degrader (BMS-986365) switch for suboptimal PSA-response in mCSPC (eARly-SWITCH).

Overview

Sponsor-declared trial summary

Key facts

Sponsor

UroTrials GmbH, AIO-Studien gGmbH

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male

Therapeutic area

Diseases [C] - Male Urogenital Diseases [C12]

Decision date (initial)

2026-05-22

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Bristol-Myers Squibb, Plaza 254 Blanchardstown Corp. Park 2, Ballycoolin, Dublin, D15 T867, Ireland

External identifiers

EU CT number

2025-523672-23-00

WHO UTN

U1111-1327-7864

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy, Safety

Primary objective of this phase II trial is to explore the efficacy of an ARPI to BMS-986365 switch in participants with suboptimal 7-months (±4 weeks) PSA response despite combined ADT + ARPI-treatment for mCSPC with PSA response-rate as primary endpoint.

Secondary objectives 9

1. To assess other surrogate parameters of BMS-986365 efficacy
2. To characterize the safety and tolerability of BMS-986365
3. To explore overall survival in the study population when treated with BMS-986365
4. To explore time to PSA response and duration of PSA response
5. To explore the effect on ECOG-performance status in this study population when treated with BMS-986365
6. To explore the confirmed PSA 30 %, 50 % and 90% response rate
7. To investigate the effect on PROs in this study population when treated with BMS-986365
8. To analyze AR alterations in tumor (if available) and peripheral blood to evaluate association with clinical efficacy
9. To analyze ctDNA at C1D1 and ctDNA changes during treatment and to evaluate association with clinical efficacy

Conditions and MedDRA coding

Metastatic Castrate Sensitive Prostate Cancer - mCSPC

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. Adult males of at least 18 years with signed written consent
2. Participants with documented metastatic castration sensitive prostate cancer
3. Detectable PSA (PSA ≥0.2 ng/ml) 7 months (± 4 weeks) after start ofanti-hormonal treatment initiation (ADT and/or ARPI, whatever was applied first)
4. Ongoing treatment with ADT and one of the following ARPIs: Abiraterone (plus Prednisone/Prednisolone), Apalutamide, Darolutamide (± Docetaxel), Enzalutamide
5. Minimum prior ARPI treatment duration of 4 months until registration
6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
7. Asymptomatic or symptomatic from metastatic prostate cancer based on BPI-SF score but must be stable with regard to BPI-SF score and pain medication, the later for at least 4 weeks prior to registration
8. Adequate blood count, liver and renal function

Exclusion criteria 5

1. Participants with predominant neuroendocrine prostate cancer (>50 %)
2. Participants with any liver metastasis
3. Participant has impaired cardiac function or clinically significant cardiac disease
4. Participants with any brain metastasis
5. Patients with 7-months PSA response < 0.2 ng/ml

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Confirmed PSA 50% response rate

Secondary endpoints 16

1. Confirmed PSA 30 % and 90% response rate
2. Confirmed absolute PSA response rates (PSA ≤0.02, >0.02 – <0.2, ≥0.2-4.0 and >4.0 ng/ml)
3. Time to PSA progression
4. Time to mCRPC
5. rPFS
6. Time to pain progression (TTPP)
7. Time to symptomatic skeletal related event (TTSSE)
8. Time to initiation of the first subsequent systemic therapy (TFST)
9. The incidence of treatment emergent AEs (according to NCI-CTC AE 5.0), SAEs, AEs leading to dose modifications, interruptions, and discontinuation, ECG findings, and laboratory abnormalities and changes from baseline (including clinical chemistry and hematology parameters)
10. Overall Survival
11. Change from baseline in NCCN FACT FPSI-17 total and subscale scores
12. Change from baseline in EQ-5D-5L
13. Change from baseline in BPI-SF
14. Analysis of AR copy number, splice variants and mutations at baseline
15. ctDNA detection rate at baseline
16. Changes in ctDNA from baseline during treatment

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

UroTrials GmbH

Sponsor organisation

UroTrials GmbH

Address

Sedanstrasse 15, Zellerau Zellerau

City

Wuerzburg

Postcode

97082

Country

Germany

Scientific contact point

Organisation

UroTrials GmbH

Contact name

Dr. Andrea Rößler

Public contact point

Organisation

UroTrials GmbH

Contact name

Dr. Andrea Rößler

AIO-Studien gGmbH

Sponsor organisation

AIO-Studien gGmbH

Address

Kuno-Fischer-Strasse 8, Charlottenburg Charlottenburg

City

Berlin

Postcode

14057

Country

Germany

Sponsor responsibilities

Article 77 compliance

UroTrials GmbH

Contact point sponsor

UroTrials GmbH

Article 77 implementation

UroTrials GmbH

Locations

1 EU/EEA country · 16 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 22 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications