Pasritamig vs Placebo in late line Metastatic Castration-resistant Prostate Cancer (mCRPC)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Janssen Cilag International

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

24 Nov 2025 → ongoing

Decision date (initial)

2025-11-18

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Pharmacokinetic, Pharmacodynamic, Safety

To determine if pasritamig + BSC compared to placebo + BSC is superior in OS

Conditions and MedDRA coding

Metastatic Castration-resistant Prostate Cancer (mCRPC)

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

Yes

IPD plan description

The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 10

1. 1. Histologically confirmed adenocarcinoma of the prostate. Primary (or pathologic evidence of conversion to) small cell carcinoma, carcinoid tumor, mixed NE carcinoma, large cell NE carcinoma, or sarcoma of the prostate is disallowed.
2. 2. mCRPC: Disease that is metastatic either to bone, any lymph node, or both without clear evidence of metastasis to visceral organs at the time of screening. Local-regional invasion (rectum, bladder) can be included.
3. 3. PSA ≥2 ng/mL at screening.
4. 4. In the opinion of the investigator, the next best treatment option is a clinical trial.
5. 5. Prior Therapy Requirements Participants should have had all life-prolonging therapies for which they are clinically eligible in the opinion of the investigator and to which they have access. Prior therapies could have been given in any disease setting (not limited to mCRPC). In particular, prior treatment specifications include receipt of the following: ARPI: Must have progressed on at least 1 ARPI and unlikely to benefit from retreatment with another ARPI. Taxanes: Should have received at least 2 previous taxane-based regimens. If a participant has received only 1 taxane regimen, the participant is eligible if: a) Cabazitaxel is not available. b) The participant’s physician deems the participant unsuitable to receive a second taxane regimen due to toxicity risk or prior intolerance. Note: a taxane-based regimen consists of at least 2 cycles of a taxane (either as a single agent or in combination with other therapies) administered within the same 2-month period. Radioligand therapy: Should have been previously treated with at least 1 dose of PSMA-targeted lutetium radioligand therapy (eg, lutetium Lu-177 vipivotide tetraxetan), unless one of the following applies: a) PSMA-targeted lutetium radioligand therapy is unavailable, not accessible, or not clinically indicated. b) The participant’s physician deems the participant unsuitable to receive PSMA-targeted lutetium radioligand therapy. PARPi: Should have been previously treated with PARPi, if the participant has a known germline or somatic BRCA mutation and treatment is available.
6. 6. Prior orchiectomy or medical castration (receiving ongoing ADT with a GnRH analog [agonist or antagonist]) prior to the first dose of study treatment and must continue this therapy throughout the treatment phase.
7. 7. Have an ECOG performance status of 0 to 2.
8. 8. Renal Function . Have an eGFR ≥30 mL/min, calculated with the CKD-epi formula, before randomization. Participants with obstructive uropathy should have treatment prior to randomization (eg, foley catheter, nephrostomy tubes, etc).
9. 9. Hepatic Function Participants are eligible if they have the following values: - ALT and AST ≤5 ×ULN. - Serum total bilirubin ≤3 x ULN
10. 10. Hematologic Values Participants should have: - ANC ≥1.0 x 109/L. - Hemoglobin ≥8.0 g/dL. - Platelet count ≥75 x 109/L Note, transfusion or growth factor usage within 28 days of randomization is not allowed.

Exclusion criteria 7

1. 1. Venous thromboembolic events (eg, pulmonary embolism) within 1 month prior to the first dose of study treatment; uncomplicated (Grade ≤2) deep vein thrombosis is not exclusionary.
2. 2. Active autoimmune disease within the 12 months prior to signing consent that quires systemic immunosuppressive medications (eg, chronic corticosteroid, methotrexate, or tacrolimus).
3. 3. Clinically significant pulmonary compromise, particularly a requirement for supplemental oxygen use (>2 L/min by nasal cannula) to maintain adequate oxygenation.
4. 4. Participant has a prior or concurrent second malignancy (other than the disease under study) for which natural history or treatment could likely interfere with any study endpoints of safety or the efficacy of the study treatment(s)
5. 5. Any of the following within 6 months prior to first dose of study treatment: - Myocardial infarction - Severe or unstable angina - Clinically significant ventricular arrhythmias - Congestive heart failure (New York Heart Association class II to IV) - Transient ischemic attack - Cerebrovascular accident
6. 6. Prior treatment with any CD3-directed therapy.
7. 7. Received immunosuppressive doses of systemic medications, such as glucocorticoids (doses >10 mg/day prednisone or equivalent) within 3 days prior to the first dose of study treatment. A single course of glucocorticoids is permitted as prophylaxis for imaging contrast (ie, for participants with allergies to contrast). If glucocorticoids were used to treat immune-related adverse events associated with prior therapy, ≥7 days must have elapsed since the last dose of corticosteroid.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Overall survival

Investigational products

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

Test 2

Placebo 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Janssen Cilag International

Sponsor organisation

Janssen Cilag International

Address

Turnhoutseweg 30

City

Beerse

Postcode

2340

Country

Belgium

Scientific contact point

Organisation

Janssen Cilag International

Contact name

CTIS Point of Contact

Public contact point

Organisation

Janssen Cilag International

Contact name

CTIS Point of Contact

Third parties 3

Locations

7 EU/EEA countries · 58 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Corrective measures 1 · Art. 77 CTR

Results and documents

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

Documents 80 files

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

Application history

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