Castration-resistant Prostate CancerPhase 2NCT06227156
Disitamab Vedotin in the Treatment With HER2- Expression, Subjects With Locally Advanced or Metastatic Castration-resistant Prostate Cancer
A Phase 2 study testing Disitamab Vedotin Injection in people with Castration-resistant Prostate Cancer, run by RemeGen Co., Ltd. at 3 sites in China.
Trial summary
The purpose of this study is to evaluate the effectiveness of Disitamab Vedotin in the treatment of subjects with locally advanced or metastatic castration-resistant prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Castration-resistant Prostate Cancer
- What is being tested?
- Disitamab Vedotin Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesChina
- Study dates
- 8 Apr 2024to Jun 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Age ≥ 18 years
- Pathology confirmed prostate adenocarcinoma
- Locally advanced or metastatic prostate cancer
- PCWG3 criteria-compliant prostate cancer progression occurs during androgen deprivation therapy (or bilateral scrotal excision). Progression will be determined based on at least 1 of the following criteria: PSA progression: defined as 2 consecutive increases in PSA, separated by at least 1 week, relative to the previous reference value. If a confirmed PSA increase is the only indicator of progression, then 1 ng/mL is the minimum starting value; Soft tissue progression: defined as an increase of ≥20% in the sum of the diameters of all target lesions (short-axis for lymph node lesions and long-axis for non-lymph node lesions) relative to the sum of the smallest diameters at the start of treatment or the presence of one or more new lesions; Bone lesion progression: defined as the detection of at least two additional new lesions on bone scan.
- Serum testosterone level ≤ 50 ng/dL (or ≤ 1.73 nmol/L), prior to the first study drug administration;
- Continuous androgen deprivation therapy (ADT) with LHRH agonists or LHRH antagonists or previous bilateral orchiectomy (surgical debridement) during the study period;
Show all 22Show fewer
- Confirmed HER2 expression (IHC 1+, 2+, 3+), HER2 gene amplification, or HER2 gene mutation;
- Subjects were able to provide paraffin blocks or at least 5 paraffin embedded sections (white pieces) for HER2 detection, and the presence of HER2 expression was confirmed by central laboratory tests (immunohistochemistry 1+, 2+, 3+)；
- Previous medical androgen deprivation therapy (or bilateral scrotal excision) and new hormone therapy (e.g. abiraterone, enzalutamide) and have developed disease progression
- The following criteria should be met within 7 days prior to the first study dose:
- haemoglobin ≥ 9 g/dL;
- absolute neutrophil count (ANC) ≥ 1.5 × 109/L;
- platelet count ≥ 100 × 109/L;
- serum total bilirubin ≤ 1.5 times the upper limit of normal (ULN);
- without liver metastasis, alanine aminotransferase and aspartate aminotransferase ≤ 2.5 × ULN; with liver metastasis, alanine aminotransferase and aspartate aminotransferase ≤ 5 × ULN;;
- albumin (ALB) ≥ 25 g/L;
- blood creatinine ≤ 1.5 × ULN, or calculated according to the Cockcroft-Gault formula, creatinine clearance (CrCl) ≥ 50 mL/min;
- left ventricular ejection fraction (LVEF) ≥ 50%;
- ECOG Physical Status Score of 0-1
- Expected survival ≥ 6 months
- Subjects whose spouses are of childbearing age must agree to use contraception during the study and for 6 months after the last dose; sperm donation is not permitted during the study and for 6 months after the last dose
- Ability to understand and sign an informed consent form.
Who cannot join
- Systematic chemotherapy, novel hormone therapy, targeted therapy, immunotherapy, or other antitumor therapy (including 5-alpha reductase inhibitors, oestrogens, and medroxyprogesterone, etc.)was administered prior to the initial study drug, and treatment ended within 5 half-lives (or 2 weeks, whichever is shorter) of the initial study drug. Except maintenance castration therapy (LHRH agonists or LHRH antagonists) or bone metastasis therapy(e.g., denosumab, zoledronic acid); In the first study, Chinese medicines with anti-tumor indications were used 2 weeks before administration.
- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis (subjects who have been treated for brain metastases may be enrolled in this study provided they have stable disease [no evidence of progression as determined by imaging for at least 4 weeks prior to study dosing and and all neurological symptoms have fully recovered], there is no evidence of new or enlarging brain metastases, and discontinuation of steroid therapy at least 7 days prior to the first dose of the trial treatment. (This exception does not include carcinomatous meningitis, which should be excluded regardless of whether it is clinically stable or not).
- Has received anti-HER2 therapy ;
- Major surgery, systemic radiotherapy or biologic therapy within 4 weeks prior to first study drug administration, or minor surgery or local radiotherapy within 1 week prior to enrollment;
- Toxicity due to prior antineoplastic therapy that has not recovered to Common Terminology Criteria for Adverse Events (CTCAE Version 5.0) Grade 1 or below, with the exception of alopecia and abnormalities in laboratory tests or toxicity associated with LHRH agonists or LHRH antagonists that are not considered by the investigator to pose a safety risk;
- Known allergic reactions to components of the study treatment or its analogues
Show all 13Show fewer
- Diagnosis of other malignancies that are expected to affect life expectancy or may interfere with disease assessment. Except for cured non-melanoma skin cancer and superficial bladder cancer
- Severe and/or persistent infection within 14 days prior to starting the study drug
- Serum virological tests: positive HBsAg test result with a positive HBV DNA copy number; positive HCVAb test result; positive HIVAb test result;
- Known serious cardiovascular disease, including any of the following: myocardial infarction, thrombotic event, or unstable angina pectoris in the past 3 months; chronic heart failure, New York Heart Association (NYHA) class II or higher; presence of unstable arrhythmia; uncontrolled hypertension;
- Combined grade 2 and higher (CTCAE version 5.0) peripheral neuropathy
- Presence of other systemic diseases that, in the judgement of the investigator, are not under stable control, including diabetes mellitus, liver cirrhosis, pneumonitis, and obstructive pulmonary disease;
- In the judgement of the investigator, there were other circumstances that made participation in the study unsuitable.
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Not yet recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Zhisong He, M.D
Zhisong He, M.D
- Not yet recruiting
The Third Medical Center of PLA General Hospital
Beijing, Beijing Municipality, 1000853
Xu Zhang, M.D
Xu Zhang
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Jun Guo, Ph.D
Jun Guo, Ph.D
About this study
Official title: A Multicenter Open Phase II to Evaluate the Safety, Efficacy and Pharmacokinetic Characteristics of Disitamab Vedotin in the Treatment With HER2- Expression, Subjects With Locally Advanced or Metastatic Castration-resistant Prostate Cancer
The purpose of this study is to evaluate the effectiveness of Disitamab Vedotin in the treatment of subjects with locally advanced or metastatic castration-resistant prostate cancer.
Read the detailed description
This is a Multicenter Open Phase II to Evaluate the Safety, Efficacy and Pharmacokinetic Characteristics of Disitamab Vedotin in the Treatment With HER2- Expression, Subjects with locally advanced or metastatic castration-resistant prostate cancer.
The study plans to enroll 40 subjects with locally advanced or metastatic CRPC with HER2 expression (IHC 1+ and above) who have been treated with androgen deprivation therapy and novel hormone therapy. Eligible subjects were enrolled and received RC48 intravenous infusion at a dose of 2.0 mg/kg every 2 weeks. Subjects received medication until disease progression, intolerable toxicity, active withdrawal, death, or study termination by the sponsor.
- Conditions
- Castration-resistant Prostate Cancer
- Being tested
- Disitamab Vedotin Injection
- Keywords
- Metastatic Castration-resistant prostate cancer., HER2- expression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Disitamab Vedotin InjectionDrug
Also called DV,RC48
2.0 mg/kg, intravenous infusion，D1, every 2 weeks is a treatment cycle
| Study group | Role | What they receive |
|---|---|---|
| Disitamab Vedotin | Experimental | Disitamab Vedotin Q2W arm Receives: Drug: Disitamab Vedotin Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic progression free survival，rPFS
Define imaging disease progression according to RECIST v1.1 (for all lesions except bone lesions) or PCWG3 (for bone lesions) as the time from the first dose of the drug to the time when the imaging shows disease progression or death.
Measured: Up to approximately 2 years
Secondary outcomes (14)
Objective remission rate (ORR)
ORR assessed according to the evaluation criteria for the efficacy of solid tumors (RECIST 1.1)
Measured: Up to approximately 2 years
Disease Control Rate (DCR)
Percentage of patients with complete response, partial response, or stable disease for a certain period of time according to RECIST v1.1.
Measured: Until progression, assessed up to approximately 2 years
Time to PSA progression(TTPP)
Defined as time from date of first dose to first PSA progression
Measured: Until progression, assessed up to approximately 2 years
Duration of response (DoR)
Defined as the time from the date of first documented response (CR/PR) until the first progression or death in the absence of disease progression by Investigators assessment according to RECIST 1.1
Measured: Until progression, assessed up to approximately 2 years
PSA response rate
Percent of subjects with different degree of decrease in PSA compared to baseline
Measured: Until progression, assessed up to approximately 2 years
Time to first symptomatic bone-related event (SSE)
Defined as the time from the first dose to the first occurrence of SSE.
Measured: Until progression, assessed up to approximately 2 years
Overall Survival (OS)
OS was defined as the time from the date of randomization to the date of death from any cause.
Measured: Up to approximately 2 years
Cmax of RC48
Peak Plasma Concentration of RC48
Measured: Up to approximately 2 years
AUC of RC48
Area under the plasma concentration versus time curve of RC48
Measured: Up to approximately 2 years
AUC of MMAE
Area under the plasma concentration versus time curve of MMAE
Measured: Up to approximately 2 years
Immunogenicity of RC48
Anti-drug antibody (ADA) of RC48 positive samples, etc.
Measured: up to approximately 2 years
Percentage of Participants With Adverse Events (AEs)
Number of participants with adverse effects of treatment. Frequency and severity of adverse effects of treatment as assessed by NCI CTCAE v5.0
Measured: Up to approximately 2 years
Incidence of laboratory tests abnormalities
To be summarized using descriptive statistics
Measured: Up to follow-up period, approximately 2 years
Incidence of ECG abnormalities
To be summarized using descriptive statistics
Measured: Up to follow-up period, approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2024
- Study start8 Apr 2024
- Primary completionDec 2025 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Castration-resistant Prostate CancerStudies of the same condition, open and under way.
- More trials run by RemeGen Co., Ltd.The 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
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RemeGen Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jianmin Fang, Ph.D, Study director, RemeGen Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06227156
- Sponsor's protocol ID
- RC48-C034
- Status last verified
- Jan 2024
- First submitted
- 17 Jan 2024
- Last updated
- 23 May 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Open Phase II to Evaluate the Safety, Efficacy and Pharmacokinetic Characteristics of Disitamab Vedotin in the Treatment With HER2- Expression, Subjects With Locally Advanced or Metastatic Castration-resistant Prostate Cancer
- ClinicalTrials.gov ID
- NCT06227156
- Acronym / sponsor ID
- RC48-C034
- Conditions
- Castration-resistant Prostate Cancer
- Keywords
- Metastatic Castration-resistant prostate cancer., HER2- expression
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- RemeGen Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 Apr 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 26 Jan 2024 (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.
The purpose of this study is to evaluate the effectiveness of Disitamab Vedotin in the treatment of subjects with locally advanced or metastatic castration-resistant prostate cancer.
Detailed description
This is a Multicenter Open Phase II to Evaluate the Safety, Efficacy and Pharmacokinetic Characteristics of Disitamab Vedotin in the Treatment With HER2- Expression, Subjects with locally advanced or metastatic castration-resistant prostate cancer.
The study plans to enroll 40 subjects with locally advanced or metastatic CRPC with HER2 expression (IHC 1+ and above) who have been treated with androgen deprivation therapy and novel hormone therapy. Eligible subjects were enrolled and received RC48 intravenous infusion at a dose of 2.0 mg/kg every 2 weeks. Subjects received medication until disease progression, intolerable toxicity, active withdrawal, death, or study termination by the sponsor.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Disitamab Vedotin | Experimental | Drug: Disitamab Vedotin InjectionDisitamab Vedotin Q2W arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Age ≥ 18 years
- Pathology confirmed prostate adenocarcinoma
- Locally advanced or metastatic prostate cancer
- PCWG3 criteria-compliant prostate cancer progression occurs during androgen deprivation therapy (or bilateral scrotal excision). Progression will be determined based on at least 1 of the following criteria: PSA progression: defined as 2 consecutive increases in PSA, separated by at least 1 week, relative to the previous reference value. If a confirmed PSA increase is the only indicator of progression, then 1 ng/mL is the minimum starting value; Soft tissue progression: defined as an increase of ≥20% in the sum of the diameters of all target lesions (short-axis for lymph node lesions and long-axis for non-lymph node lesions) relative to the sum of the smallest diameters at the start of treatment or the presence of one or more new lesions; Bone lesion progression: defined as the detection of at least two additional new lesions on bone scan.
- Serum testosterone level ≤ 50 ng/dL (or ≤ 1.73 nmol/L), prior to the first study drug administration;
Key exclusion criteria (13 listed)
- Systematic chemotherapy, novel hormone therapy, targeted therapy, immunotherapy, or other antitumor therapy (including 5-alpha reductase inhibitors, oestrogens, and medroxyprogesterone, etc.)was administered prior to the initial study drug, and treatment ended within 5 half-lives (or 2 weeks, whichever is shorter) of the initial study drug. Except maintenance castration therapy (LHRH agonists or LHRH antagonists) or bone metastasis therapy(e.g., denosumab, zoledronic acid); In the first study, Chinese medicines with anti-tumor indications were used 2 weeks before administration.
- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis (subjects who have been treated for brain metastases may be enrolled in this study provided they have stable disease [no evidence of progression as determined by imaging for at least 4 weeks prior to study dosing and and all neurological symptoms have fully recovered], there is no evidence of new or enlarging brain metastases, and discontinuation of steroid therapy at least 7 days prior to the first dose of the trial treatment. (This exception does not include carcinomatous meningitis, which should be excluded regardless of whether it is clinically stable or not).
- Has received anti-HER2 therapy ;
- Major surgery, systemic radiotherapy or biologic therapy within 4 weeks prior to first study drug administration, or minor surgery or local radiotherapy within 1 week prior to enrollment;
- Toxicity due to prior antineoplastic therapy that has not recovered to Common Terminology Criteria for Adverse Events (CTCAE Version 5.0) Grade 1 or below, with the exception of alopecia and abnormalities in laboratory tests or toxicity associated with LHRH agonists or LHRH antagonists that are not considered by the investigator to pose a safety risk;
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 InjectionAlso: DV,RC482.0 mg/kg, intravenous infusion，D1, every 2 weeks is a treatment cycle | Drug | Disitamab Vedotin |
Primary outcome
Radiographic progression free survival，rPFS
Time frame: Up to approximately 2 years
Define imaging disease progression according to RECIST v1.1 (for all lesions except bone lesions) or PCWG3 (for bone lesions) as the time from the first dose of the drug to the time when the imaging shows disease progression or death.
14 secondary outcomes
Objective remission rate (ORR)
Time frame: Up to approximately 2 years
Disease Control Rate (DCR)
Time frame: Until progression, assessed up to approximately 2 years
Time to PSA progression(TTPP)
Time frame: Until progression, assessed up to approximately 2 years
Duration of response (DoR)
Time frame: Until progression, assessed up to approximately 2 years
PSA response rate
Time frame: Until progression, assessed up to approximately 2 years
Time to first symptomatic bone-related event (SSE)
Time frame: Until progression, assessed up to approximately 2 years
Overall Survival (OS)
Time frame: Up to approximately 2 years
Cmax of RC48
Time frame: Up to approximately 2 years
AUC of RC48
Time frame: Up to approximately 2 years
AUC of MMAE
Time frame: Up to approximately 2 years
Immunogenicity of RC48
Time frame: up to approximately 2 years
Percentage of Participants With Adverse Events (AEs)
Time frame: Up to approximately 2 years
Incidence of laboratory tests abnormalities
Time frame: Up to follow-up period, approximately 2 years
Incidence of ECG abnormalities
Time frame: Up to follow-up period, approximately 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2024.
- Individual participant dataSharing planned: No
Related trials for Castration-resistant Prostate Cancer
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
RecruitingPhase 2
A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer
Metastatic Castration-Resistant Prostate Cancer
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
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
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. This study is not recruiting at the moment.
Jianmin Fang, Ph.D study director
RemeGen Co., Ltd.
3 sites 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 Injection in people with Castration-resistant Prostate Cancer, run by RemeGen Co., Ltd. at 3 sites 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 22 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 23 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jianmin Fang, Ph.D (+8610-58075763, Jianminfang@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic progression free survival，rPFS (time frame: Up to approximately 2 years). 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 23 May 2024.