Clinical Study on the Efficacy and Safety of RC48-ADC in the Treatment of Metastatic Castration Resistant Prostate Cancer (mCRPC)

NCT ID: NCT05955209

Last Updated: 2023-07-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2025-08-01

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.

Conditions

Metastatic Castration-resistant Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Disitamab Vedotin(RC48-ADC)

Disitamab Vedotin(RC48-ADC) :2.0mg/kg，Q2W

Group Type: EXPERIMENTAL

Disitamab Vedotin（RC48-ADC）

Intervention Type: DRUG

Participants will receive RC48-ADC intravenous injection (2.0 mg/kg, Q2W) until disease progression or death.

Interventions

Disitamab Vedotin（RC48-ADC）

Participants will receive RC48-ADC intravenous injection (2.0 mg/kg, Q2W) until disease progression or death.

Intervention Type: DRUG

Other Intervention Names

RC48

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;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University Cancer Hospital & Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shuo Wang, Doctor

Role: PRINCIPAL_INVESTIGATOR

Peking University Cancer Hospital & Institute

Central Contacts

Yudong Cao, Doctor

Role: CONTACT

ydcao@bjmu.edu.cn

15110101301

Other Identifiers

RCVDTYPEC053

Identifier Type: -

Identifier Source: org_study_id