Trials / Unknown
UnknownNCT05955209
Clinical Study on the Efficacy and Safety of RC48-ADC in the Treatment of Metastatic Castration Resistant Prostate Cancer (mCRPC)
An Open, Single Arm, Single Center Phase II Clinical Study Evaluating the Efficacy and Safety of RC48-ADC in the Treatment of Metastatic Castration Resistant Prostate Cancer (mCRPC) Progression After Novel Endocrine Therapy
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- Sponsor
- Peking University Cancer Hospital & Institute · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a single-arm, open, single-center clinical study to evaluate the efficacy and safety of RC48-ADC in patients with mCRPC who have progressed after NHT. A total of 40 patients with mCRPC with immunohistochemically confirmed HER2 expression who had progressed after treatment with at least one novel endocrine therapy will be included in this study.
Detailed description
This is a single-arm, open, single-center clinical study to evaluate the efficacy and safety of RC48-ADC in patients with mCRPC who have progressed after NHT. A total of 40 patients with mCRPC with immunohistochemically confirmed HER2 expression who had progressed after treatment with at least one novel endocrine therapy will be included in this study. Participants will receive RC48-ADC intravenous injection (2.0 mg/kg, Q2W) until disease progression or death. During the treatment, participants will evaluate every 4 weeks, including PSA testing every 4 weeks and tumor evaluation according to PCWG3 standards every 8 weeks. If the patient develops disease progression, the treatment will be discontinued and survival follow-up will be conducted every 8 weeks.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Disitamab Vedotin（RC48-ADC） | Participants will receive RC48-ADC intravenous injection (2.0 mg/kg, Q2W) until disease progression or death. |
Timeline
- Start date
- 2023-08-01
- Primary completion
- 2024-08-01
- Completion
- 2025-08-01
- First posted
- 2023-07-21
- Last updated
- 2023-07-21
Source: ClinicalTrials.gov record NCT05955209. Inclusion in this directory is not an endorsement.