mCRPCPhase 2NCT07093866
Efficacy and Safety of Disitamab Vedotin Plus Abiraterone for Metastatic Castration-Resistant Prostate Cancer：a Phase II Study
A Phase 2 study testing Disitamab Vedotin (RC48) and Abiraterone + prednisone in people with mCRPC, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
Trial summary
This is an open-label，prospective，single-arm，phase 2 trial aims to evaluate the efficacy and safety of disitamab vedotin combined with abiraterone in patients with metastatic castration-resistant prostate cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- mCRPC
- What is being tested?
- Disitamab Vedotin (RC48) and Abiraterone + prednisone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 20 Jul 2025to 30 Dec 2027
- Phase
- Phase 2
- 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 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients are able to understand and voluntarily sign the informed consent form (ICF); judged by the investigator to be capable of complying with the protocol.
- Male patients of ≥18 years or older at the time of ICF signature.
- Patients with ECOG performance status 0-1.
- Patients with an expected survival of 3months or more.
- Patients who are histologically or cytologically confirmed prostatic adenocarcinoma with HER2 expression (IHC 1+, 2+ or 3+) in archival or fresh tumour tissue.
- Patients with documented castration-resistant prostate cancer (CRPC): serum testosterone <1.73 nmol/L (50 ng/dL) at screening; patients on medical castration must continue LHRH agonist/antagonist therapy throughout the study.
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- Patients with evidence of metastatic disease by bone scan (bone lesions) and/or CT/MRI (soft-tissue lesions).
- Patients with adequate organ function as defined below:
- Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L
- Platelet count (PLT) ≥100 × 10⁹/L
- Hemoglobin (Hb) ≥100 g/L
- Total bilirubin (TBIL) ≤1.5 × upper limit of normal (ULN); ≤2 × ULN if liver metastases present
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5 × ULN; ≤2 × ULN if liver metastases present
- Serum creatinine (Cr) ≤1.5 × ULN or calculated creatinine clearance (CrCl) ≥60 mL/min (Cockcroft-Gault formula; calculate only if Cr >1.5 × ULN)
- Urinalysis protein <2+; if ≥2+, 24-h urine protein must be <1 g or urine protein/creatinine ratio <0.5
- For patients not on anticoagulation: INR and aPTT ≤1.5 × ULN; patients on stable-dose anticoagulation are eligible
- Left ventricular ejection fraction (LVEF) ≥50% or ≥local lower limit of normal (LLN), whichever is lower
- QTcF interval <470 ms
- Male patients with partners of child-bearing potential must use a medically acceptable contraceptive method from the first study dose until 3 months after the last dose.
Who cannot join
- Patients who are known hypersensitivity to any component of disitamab vedotin or abiraterone.
- Patients with other malignancies within 3 years before screening, except early-stage malignancies considered clinically cured (carcinoma in situ or stage I tumors), e.g., basal-cell or squamous-cell skin carcinoma or superficial bladder cancer.
- Patients with central nervous system (CNS) metastases and/or carcinomatous meningitis. Patients with treated brain metastases may enroll if lesions have been stable for ≥1 month, there is no evidence of new or enlarging CNS disease, and systemic corticosteroids have been discontinued ≥3 days before the first study dose.
- Patients who are clinically significant pericardial effusion, or pleural/peritoneal/pelvic effusions that are poorly controlled or require drainage within 2 weeks before the first dose.
- Patients with major surgical intervention (any grade 3 or 4 procedure per the 2009 Chinese Regulation on Clinical Application of Medical Technologies) within 4 weeks before the first dose, or incomplete post-operative recovery that, in the investigator's judgment, poses a risk to trial participation.
- Patients who are prior PSMA-targeted therapy.
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- Patients within 4 weeks (6 weeks for nitrosoureas or mitomycin C) before the first dose: any antineoplastic chemotherapy (except castration therapy), radiotherapy (>1 week of local palliative radiotherapy permitted), endocrine therapy (estrogens or anti-androgens; bicalutamide or nilutamide require 6-week washout), targeted therapy, immunotherapy, or participation in another interventional clinical trial (observational studies or post-trial follow-up are allowed).
- Patients with stable-dose denosumab or bisphosphonates for bone metastases are permitted.
- mCRPC patients must not have used PSA-lowering herbal agents (e.g., saw palmetto) or systemic corticosteroids (except short courses for allergy prophylaxis/treatment) within 4 weeks before the first dose, nor plan to use such agents during the study.
- Patients with use of antineoplastic traditional Chinese medicine (TCM) prescriptions or proprietary TCM within 1 week, or receipt of blood transfusion/blood products, hematopoietic growth factors, or other agents to correct blood cell counts within 2 weeks before first study dose.
- Patients with toxicities from prior antineoplastic therapy that have not resolved to baseline, CTCAE v5.0 grade 0-1 (except alopecia and pigmentation), or to the levels specified in the inclusion/exclusion criteria; unhealed wounds. Irreversible toxicities not expected to worsen with study drug (e.g., hearing loss) are permitted.
- Patients with unexplained fever >38.5 °C (tumor-related fever may be allowed per investigator judgment); active or persistent infection; HIV antibody positive; HBsAg positive with HBV DNA > site ULN, or HBsAg-negative/HBcAb-positive with HBV DNA > site ULN after treatment; HCV antibody positive with HCV RNA > site ULN; active syphilis (except adequately treated, cured, or stable syphilis).
- NYHA class III/IV congestive heart failure; uncontrolled arrhythmia despite treatment/intervention; risk of QT prolongation or use of drugs known to prolong QT; refractory hypertension (hypertension controlled to <140/90 mmHg on medication is allowed).
- Patients with clinically significant vascular events within 6 months before first dose, including acute arterial/venous thromboembolism, thrombotic arteritis, thrombophlebitis, acute pulmonary embolism, acute coronary syndrome (MI, unstable angina, etc.), acute cerebrovascular events, or disseminated intravascular coagulation.
- Patients with tumor metastases with clear invasion of major arteries posing a high bleeding risk.
- Patients with interstitial pneumonitis, pulmonary fibrosis, or other severe pulmonary disease requiring treatment; hemoptysis >2.5 mL per episode within 3 weeks before first dose.
- Patients with active gastro-intestinal ulcer, perforation, and/or fistula requiring treatment within 6 months; GI bleeding (hematemesis, melena, or hematochezia) within 3 months without endoscopic/colonoscopic evidence of complete healing.
- Patients with uncontrolled concurrent disease >CTCAE v5.0 grade 2 (e.g., diabetes).
- Uncontrolled concurrent disease >CTCAE v5.0 grade 2 (e.g., diabetes).
- Patients with CTCAE v5.0 grade >2 peripheral neuropathy, prior epilepsy, psychiatric disorders; history of drug abuse within 6 months or alcohol abuse within 3 months (alcohol abuse defined as >14 units/week: 1 unit = 285 mL beer, 25 mL spirits, or 80 mL wine).
- Patients with autoimmune disease, immunodeficiency, or organ transplantation.
- Patients with any condition, therapy, or laboratory abnormality that, in the investigator's opinion, could confound results, interfere with trial participation, or be not in the subject's best interest.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Nanjing, Jiangsu 210000
Nanjing, Jiangsu, 210000
Hongqian Guo Hongqian Guo, PhD, 8613605171690, dr.ghq@nju.edu.cn
About this study
This is an open-label，prospective，single-arm，phase 2 trial aims to evaluate the efficacy and safety of disitamab vedotin combined with abiraterone in patients with metastatic castration-resistant prostate cancer.
- Conditions
- mCRPC
- Being tested
- Disitamab Vedotin (RC48), Abiraterone + prednisone
- Keywords
- mCRPC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Disitamab Vedotin (RC48)Drug
Disitamab Vedotin 2mg/kg is administered intravenously once every 2 weeks (1 cycle)
Abiraterone + prednisoneDrug
Abiraterone 1000mg is administered orally once a day，and prednisone 5mg is administered orally twice a day.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | mCRPC subjects with IHC 1+/IHC 2+/IHC3+ are administered Disitamab Vedotin combined with Abiraterone Receives: Drug: Disitamab Vedotin (RC48); Drug: Abiraterone + prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
PSA 50
Proportion of patients with a ≥50 % prostate-specific antigen (PSA) reduction from baseline at Week 12, confirmed by a repeat assessment at least 3 weeks later.
Measured: baseline up to 24 weeks
Secondary outcomes (3)
PSA 30
Proportion of patients with a ≥30 % prostate-specific antigen (PSA) reduction from baseline at Week 12, confirmed by a repeat assessment at least 3 weeks later.
Measured: baseline up to 24 weeks
PSA 90
Proportion of patients with a ≥90 % prostate-specific antigen (PSA) reduction from baseline at Week 12, confirmed by a repeat assessment at least 3 weeks later.
Measured: baseline up to 24 weeks
Radiographic Progression-Free Survival（rPFS）
Time from the first day of study drug administration to the earlier of radiographic progression or death from any cause.
Measured: From baseline until radiographic progression or death from any cause, whichever comes first. assessed up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start20 Jul 2025 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for mCRPCStudies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Experimental regimen: Disitamab vedotin +Abiraterone +Prednisone
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Nanjing University
- Responsible party
- Principal investigator, Hongqian Guo, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07093866
- Sponsor's protocol ID
- IUNU-PC-125
- Status last verified
- Jul 2025
- First submitted
- 22 Jul 2025
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Disitamab Vedotin Plus Abiraterone for Metastatic Castration-Resistant Prostate Cancer：a Phase II Study
- ClinicalTrials.gov ID
- NCT07093866
- Acronym / sponsor ID
- IUNU-PC-125
- Conditions
- mCRPC
- Keywords
- mCRPC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Collaborators
- Nanjing University
- Study start
- 20 Jul 2025 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 30 Jul 2025 (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 is an open-label，prospective，single-arm，phase 2 trial aims to evaluate the efficacy and safety of disitamab vedotin combined with abiraterone in patients with metastatic castration-resistant prostate cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Experimental regimen: Disitamab vedotin +Abiraterone +Prednisone
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: Disitamab Vedotin (RC48), Drug: Abiraterone + prednisonemCRPC subjects with IHC 1+/IHC 2+/IHC3+ are administered Disitamab Vedotin combined with Abiraterone |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Patients are able to understand and voluntarily sign the informed consent form (ICF); judged by the investigator to be capable of complying with the protocol.
- Male patients of ≥18 years or older at the time of ICF signature.
- Patients with ECOG performance status 0-1.
- Patients with an expected survival of 3months or more.
- Patients who are histologically or cytologically confirmed prostatic adenocarcinoma with HER2 expression (IHC 1+, 2+ or 3+) in archival or fresh tumour tissue.
Key exclusion criteria (22 listed)
- Patients who are known hypersensitivity to any component of disitamab vedotin or abiraterone.
- Patients with other malignancies within 3 years before screening, except early-stage malignancies considered clinically cured (carcinoma in situ or stage I tumors), e.g., basal-cell or squamous-cell skin carcinoma or superficial bladder cancer.
- Patients with central nervous system (CNS) metastases and/or carcinomatous meningitis. Patients with treated brain metastases may enroll if lesions have been stable for ≥1 month, there is no evidence of new or enlarging CNS disease, and systemic corticosteroids have been discontinued ≥3 days before the first study dose.
- Patients who are clinically significant pericardial effusion, or pleural/peritoneal/pelvic effusions that are poorly controlled or require drainage within 2 weeks before the first dose.
- Patients with major surgical intervention (any grade 3 or 4 procedure per the 2009 Chinese Regulation on Clinical Application of Medical Technologies) within 4 weeks before the first dose, or incomplete post-operative recovery that, in the investigator's judgment, poses a risk to trial participation.
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 |
|---|---|---|
| Disitamab Vedotin (RC48)Disitamab Vedotin 2mg/kg is administered intravenously once every 2 weeks (1 cycle) | Drug | Arm A |
| Abiraterone + prednisoneAbiraterone 1000mg is administered orally once a day，and prednisone 5mg is administered orally twice a day. | Drug | Arm A |
Primary outcome
PSA 50
Time frame: baseline up to 24 weeks
Proportion of patients with a ≥50 % prostate-specific antigen (PSA) reduction from baseline at Week 12, confirmed by a repeat assessment at least 3 weeks later.
3 secondary outcomes
PSA 30
Time frame: baseline up to 24 weeks
PSA 90
Time frame: baseline up to 24 weeks
Radiographic Progression-Free Survival（rPFS）
Time frame: From baseline until radiographic progression or death from any cause, whichever comes first. assessed up to 36 months
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 30 Jul 2025.
- Individual participant dataSharing planned: No
Related trials for mCRPC
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
RecruitingObservational study
ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical Trials
Prostate Cancer, Prostate Adenocarcinoma
Active, not recruitingPhase 2
FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Metastatic Castration-resistant Prostate Cancer
Active, not recruitingPhase 3
Talazoparib + Enzalutamide vs. Enzalutamide Monotherapy in mCRPC
mCRPC
RecruitingPhase 3
Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003)
Prostate Cancer Metastatic
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Disitamab Vedotin (RC48) and Abiraterone + prednisone in people with mCRPC, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
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 19 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: looking for participants now, as of the sponsor's last update on 30 Jul 2025. 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 China. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Hongqian Guo Hong qian Guo (8613605171690, gymwpi@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PSA 50 (time frame: baseline up to 24 weeks). 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 30 Jul 2025.