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Trial Title:
Clinical Study on the Efficacy and Safety of RC48-ADC in the Treatment of Metastatic Castration Resistant Prostate Cancer (mCRPC)
NCT ID:
NCT05955209
Condition:
Metastatic Castration-resistant Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Disitamab vedotin
Conditions: Keywords:
RC48-ADC
metastasis Castration Resistant Prostate Cancer
HER2
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Disitamab Vedotin（RC48-ADC）
Description:
Participants will receive RC48-ADC intravenous injection (2.0 mg/kg, Q2W) until disease
progression or death.
Arm group label:
Disitamab Vedotin(RC48-ADC)
Other name:
RC48
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
-
1) Prostate cancer confirmed by histology;
-
2) ≥ 18 years old;
-
3) The presence of metastatic lesions confirmed by bone scan and/or CT/MRI and/or
PET-CT;
-
4) ECOG score 0-2;
-
5) Continuously maintain ADT treatment and maintain testosterone levels ≤ 50ng/dL;
The progression of prostate cancer recorded within 6 months prior to screening;
-
6) Having received at least one NHT in the past before progressing;
-
7) HER2 IHC 1+, 2+, or 3+;
-
8) Inability to or refusal docetaxel chemotherapy;
-
9) Voluntarily join the study;
-
10) Expected survival time ≥ 6 months;
-
11) Normal function of main organs;
Exclusion Criteria:
- 1)Have a history of malignant tumors other than prostate cancer;
- 2)Previously received allogeneic stem cell or parenchymal organ transplantation;
-
3) Previously or currently suffering from congenital or acquired immunodeficiency
diseases;
-
4) The patient have a history of allergy to RC48 or paclitaxel, or a history of
Hypersensitivity to chimeric or humanized antibodies or fusion proteins, or
allergy to excipients of the study drug;
-
5) Other significant clinical and laboratory abnormalities that affect safety
evaluation;
-
6) Those who are unwilling or unable to take effective contraceptive measures;
-
7) Subjects with active brain metastasis;
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
August 1, 2023
Completion date:
August 1, 2025
Lead sponsor:
Agency:
Peking University Cancer Hospital & Institute
Agency class:
Other
Source:
Peking University Cancer Hospital & Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05955209
