Clinical trial NCT05955209: Clinical Study on the Efficacy and Safety of RC48-ADC in the Treatment of Metastatic Castration Resistant Prostate Cancer (mCRPC)
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Metastatic Castration-resistant Prostate Cancer
Keywords: RC48-ADC
metastasis Castration Resistant Prostate Cancer
HER2
Lead sponsor: Peking University Cancer Hospital & Institute
Sponsor class: OTHER
First posted: 2023-07-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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;

Primary outcomes:
measure: PSA response rate
timeFrame: 24 months
Secondary outcomes:
measure: ORR，Objective Response Rate
timeFrame: 24 months
measure: Overall survival (OS)
timeFrame: From the first dose to death from any cause，up to two years.
measure: Progression free survival
timeFrame: From the first dose to the first documentation of disease progression or death, up to two years.
Other outcomes:
Locations:
Study officials:
affiliation: Peking University Cancer Hospital & Institute
name: Shuo Wang, Doctor
role: PRINCIPAL_INVESTIGATOR
References: