Prostate CancerPhase 1NCT07860255
Testing Pasritamig Before Surgery for the Treatment of Localized Prostate Cancer
A Phase 1 study testing Pasritamig in people with Prostate Cancer, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Pasritamig
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2026to 30 Nov 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be willing to provide informed consent prior to any study specific procedures.
- Age ≥ 18 years.
- Documented histologically confirmed adenocarcinoma of the prostate:
- Unfavourable intermediate risk:
- --- Grade Group 1 with PSA 10-20 ng/mL, T2b-T2c OR Grade Group 2 with PSA 10-20 ng/mL, T2b-T2c, and/or ≥50% biopsy cores positive OR Grade Group 3 with PSA <20 ng/mL.
- High-risk localized prostate cancer with no very-high-risk features and exactly one high-risk feature:
Show all 25Show fewer
- T3a OR
- Grade Group 4 or 5 OR
- PSA > 20 ng/dL
- Very high-risk localized prostate cancer. At least one of the following:
- T3b-T4
- Primary Gleason pattern 5
- 2 or 3 high-risk features
- >4 cores with Grade Group 4 or 5
- Negative for distant metastases on conventional (i.e. CT bone scan) and PSMA PET imaging within 60 days of enrollment. Patients with evidence of non-measurable (i.e. per RECIST v1.1) metastatic lymphadenopathy as detected by PSMA PET will be eligible if ≤3 radiation isocenters are detectable.
- Eastern cooperative oncology group performance (ECOG) status 0-1.
- Eligible and planned for radical prostatectomy.
- Must have adequate archival biopsy tissue available for KLK2 assessment.
- Participants who are sexually active with a partner of childbearing potential or a pregnant partner must agree to use contraception, including a condom, during study treatment and for at least 6 months after the last dose of pasritamig. Participants must also agree not to donate sperm during study treatment and for at least 6 months after the last dose of pasritamig.
- Patients must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment as defined below:
- Hemoglobin ≥ 9 g/dL with no blood transfusion in the past 28 days
- Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L; however, participants with documented Duffy-null associated neutrophil count or other benign chronic neutropenia may be eligible with ANC ≥1.0 × 10⁹/L if clinically stable and without a history of recurrent or severe infections, at the discretion of the investigator. Platelet count ≥ 100 x 109/L
- Total bilirubin ≤1.5 × institutional upper limit of normal (ULN), except participants with known or suspected Gilbert syndrome may be eligible with total bilirubin ≤3 × ULN, provided direct bilirubin is ≤1.5 × ULN and there is no clinical evidence of hepatic dysfunction.Aspartate aminotransferase (AST) (Serum Glutamic Oxaloacetic Transaminase (SGOT)) / Alanine aminotransferase (ALT) (Serum Glutamic Pyruvate Transaminase (SGPT)) ≤ 2.5 x institutional upper limit of normal unless liver metastases are present in which case they must be ≤ 5x ULN
- Patients must have creatinine clearance estimated of ≥30 mL/min:
- Estimated creatinine clearance = (140-age [years]) x weight (kg) / serum creatinine (mg/dL) x 72
Who cannot join
- 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).
- 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 (i.e., 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.
- Received or plans to receive any live, attenuated vaccine within 4 weeks before the first dose of study treatment. Live, attenuated influenza vaccines are permitted as late as 7 days before the study treatment.
Show all 22Show fewer
- Distant metastasis based on conventional imaging (clinical stage M1) and PSMA PET within 60 days of enrollment. Nodal disease below the iliac bifurcation (clinical stage N1) is not an exclusion. Diagnosis of distant metastasis (clinical M stage; M0 versus M1a, M1b, M1c) and pelvic nodal disease (clinical N stage; N1 versus N0) will be assessed by central radiological review. Participants are considered eligible only if the central radiological review confirms clinical stage M0. As noted above, non-measurable nodal metastases detected on PSMA PET will be allowed to enroll if radiation isocenters are detectable.
- cT4 disease (tumor is fixed or invades adjacent structures other than seminal vesicles) is excluded.
- Prior androgen deprivation therapy or other systemic treatment for prostate cancer.
- Prior treatment with KLK2-targeted therapy and/or with any CD3-directed therapy
- Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. This includes, but not limited to, the following:
- Patients with positive HIV titers or active hepatitis (i.e., Hepatitis B or C) due to risk of transmitting the infection through blood or other body fluids.
- Evidence of serious and/or unstable pre-existing medical, psychiatric or other condition (including laboratory abnormalities) that could interfere with patient safety or provision of informed consent to participate in this study.
- Any psychological, familial, sociological, or geographical condition that could potentially interfere with compliance with the study protocol and follow-up schedule.
- 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
- Active autoimmune disease within the 12 months prior to signing consent that requires systemic immunosuppressive medications (e.g., chronic corticosteroid, methotrexate, or tacrolimus).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
Fred Hutch Immunotherapy Intake, 206-606-4668, immunotherapy@fredhutch.org
Steven Blinka, MD, PhD
About this study
Official title: A Neoadjuvant Trial of Pasritamig in Unfavorable Intermediate to Very High-Risk Localized Prostate Cancer
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.
- Conditions
- Prostate Cancer
- Being tested
- Pasritamig
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PasritamigDrug
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant Pasritamig | Experimental | Participants receive pasritamig IV on days 1, 8, 15, and 57. Participants then undergo standard of care radical prostatectomy. Participants also undergo blood and tissue sample collection on study. Receives: Drug: Pasritamig |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From first dose through radical prostatectomy, approximately 70 days
Change in intratumoral CD3+ T-cell density
Measured as CD3-positive T cells per mm² of evaluable tumor area
Measured: Baseline to radical prostatectomy, approximately 70 days
Secondary outcomes (8)
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.
Measured: At radical prostatectomy, approximately Day 70
Change in prostate-specific antigen (PSA)
Measured: Screening through approximately 12 weeks following radical prostatectomy
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.
Measured: From radical prostatectomy through up to 3 years of follow-up
Pathologic complete response (pCR)
Proportion of evaluable participants with no residual viable tumor identified on standard H\&E evaluation of the radical prostatectomy specimen.
Measured: At radical prostatectomy, approximately Day 70
Pathologic downstaging
Proportion of evaluable participants with a lower pathologic T stage at radical prostatectomy compared with baseline clinical T stage.
Measured: At radical prostatectomy, approximately Day 70
Proportion of participants with pathologic minimal residual disease (pMRD)
Proportion of evaluable participants with residual viable carcinoma ≤5 mm in the greatest dimension of the largest residual tumor lesion and prostate-confined, lymph-node-negative disease (≤ypT2, ypN0).
Measured: At radical prostatectomy, approximately Day 70
Pathologic minimal residual disease (pMRD)
pMRD is defined as residual viable carcinoma ≤5 mm in the greatest dimension of the largest residual tumor lesion with ≤ypT2 and ypN0 disease.
Measured: At radical prostatectomy, approximately Day 70
Residual cancer burden (RCB)
RCB will also be quantified, with favorable RCB defined as ≤0.25 cm³ with ≤ypT2 and ypN0 disease.
Measured: At radical prostatectomy, approximately Day 70
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study start30 Nov 2026 (estimated)
- Primary completion30 Nov 2028 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Johnson & Johnson
- Responsible party
- Sponsor
- Investigators
- Steven Blinka, MD, PhD, Principal investigator, Fred Hutchinson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07860255
- Sponsor's protocol ID
- RG1126867
- Status last verified
- Oct 2026
- First submitted
- 1 Oct 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Neoadjuvant Trial of Pasritamig in Unfavorable Intermediate to Very High-Risk Localized Prostate Cancer
- ClinicalTrials.gov ID
- NCT07860255
- Acronym / sponsor ID
- RG1126867
- Conditions
- Prostate Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- Johnson & Johnson
- Study start
- 30 Nov 2026 (estimated)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 6 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant Pasritamig | Experimental | Drug: PasritamigParticipants receive pasritamig IV on days 1, 8, 15, and 57. Participants then undergo standard of care radical prostatectomy. Participants also undergo blood and tissue sample collection on study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Must be willing to provide informed consent prior to any study specific procedures.
- Age ≥ 18 years.
- Documented histologically confirmed adenocarcinoma of the prostate:
- --- Grade Group 1 with PSA 10-20 ng/mL, T2b-T2c OR Grade Group 2 with PSA 10-20 ng/mL, T2b-T2c, and/or ≥50% biopsy cores positive OR Grade Group 3 with PSA <20 ng/mL.
- Negative for distant metastases on conventional (i.e. CT bone scan) and PSMA PET imaging within 60 days of enrollment. Patients with evidence of non-measurable (i.e. per RECIST v1.1) metastatic lymphadenopathy as detected by PSMA PET will be eligible if ≤3 radiation isocenters are detectable.
Key exclusion criteria (22 listed)
- 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).
- 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 (i.e., 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PasritamigGiven IV | Drug | Neoadjuvant Pasritamig |
Primary outcome
Feasibility of neoadjuvant pasritamig
Time frame: From first dose through radical prostatectomy, approximately 70 days
Proportion of participants who complete planned neoadjuvant pasritamig and undergo radical prostatectomy within the protocol-defined surgical window without treatment-related delay.
Change in intratumoral CD3+ T-cell density
Time frame: Baseline to radical prostatectomy, approximately 70 days
Measured as CD3-positive T cells per mm² of evaluable tumor area
8 secondary outcomes
Adverse pathologic features
Time frame: At radical prostatectomy, approximately Day 70
Change in prostate-specific antigen (PSA)
Time frame: Screening through approximately 12 weeks following radical prostatectomy
Time to biochemical recurrence or death
Time frame: From radical prostatectomy through up to 3 years of follow-up
Pathologic complete response (pCR)
Time frame: At radical prostatectomy, approximately Day 70
Pathologic downstaging
Time frame: At radical prostatectomy, approximately Day 70
Proportion of participants with pathologic minimal residual disease (pMRD)
Time frame: At radical prostatectomy, approximately Day 70
Pathologic minimal residual disease (pMRD)
Time frame: At radical prostatectomy, approximately Day 70
Residual cancer burden (RCB)
Time frame: At radical prostatectomy, approximately Day 70
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Steven Blinka, MD, PhD principal investigator
Fred Hutchinson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pasritamig in people with Prostate Cancer, run by Fred Hutchinson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fred Hutch Immunotherapy Intake (206-606-4668, immunotherapy@fredhutch.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of neoadjuvant pasritamig (time frame: From first dose through radical prostatectomy, approximately 70 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.