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Testing Pasritamig Before Surgery for the Treatment of Localized Prostate Cancer

ConditionProstate Cancer
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18+
SponsorFred Hutchinson Cancer Center

About this trial

This phase I trial tests the safety and feasibility of giving pasritamig before surgery in patients with unfavorable intermediate-risk, high-risk, or very high-risk localized prostate cancer. Pasritamig is a bispecific antibody that works by bringing immune cells called T cells close to prostate cancer cells that express KLK2, which may help the immune system attack the cancer. Giving pasritamig before radical prostatectomy may help researchers determine how the drug affects prostate cancer and the immune cells within the tumor.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Must be willing to provide informed consent prior to any study specific procedures.

Age ≥ 18 years.

T3a OR

Grade Group 4 or 5 OR

Disqualifiers

Subjects with small cell or neuroendocrine prostate cancer.

Active infection or condition that requires treatment with systemic antibiotics within 7 days prior to the first dose of study treatment. Prophylactic anti-infective agents are allowed.

Solid organ or bone marrow transplantation.

Suspected or known allergies, hypersensitivity, or intolerance to excipients of pasritamig (refer to the latest IB for pasritamig).

Trial design

Design model

Single group

Treatments tested in this trial

  • Pasritamig

    Drug

    Given IV

Treatment groups

18 Participants
are divided into 1 treatment group
Group A: Neoadjuvant PasritamigExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Feasibility of neoadjuvant pasritamig

Proportion of participants who complete planned neoadjuvant pasritamig and undergo radical prostatectomy within the protocol-defined surgical window without treatment-related delay.

Time frame
From first dose through radical prostatectomy, approximately 70 days
2

Change in intratumoral CD3+ T-cell density

Measured as CD3-positive T cells per mm² of evaluable tumor area

Time frame
Baseline to radical prostatectomy, approximately 70 days

Secondary outcomes

1

Adverse pathologic features

Number and proportion of evaluable participants with extraprostatic extension (≥ypT3a), seminal vesicle invasion (ypT3b), regional lymph node involvement (ypN1), positive surgical margins, and any adverse pathologic feature.

Time frame
At radical prostatectomy, approximately Day 70
2

Change in prostate-specific antigen (PSA)

Time frame
Screening through approximately 12 weeks following radical prostatectomy
3

Time to biochemical recurrence or death

Time from radical prostatectomy to biochemical recurrence or death, whichever occurs first. Biochemical recurrence is defined as postoperative PSA ≥0.2 ng/mL, confirmed by a second PSA ≥0.2 ng/mL when clinically feasible.

Time frame
From radical prostatectomy through up to 3 years of follow-up
4

Pathologic complete response (pCR)

Proportion of evaluable participants with no residual viable tumor identified on standard H\&E evaluation of the radical prostatectomy specimen.

Time frame
At radical prostatectomy, approximately Day 70

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fred Hutchinson Cancer Center

Lead sponsor

Johnson & Johnson

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: