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

NCT05955209 | Unknown Phase 2

• 1 other identifier: RCVDTYPEC053
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Metastatic Castration-resistant Prostate Cancer

Keywords

RC48-ADC; metastasis Castration Resistant Prostate Cancer; HER2

Outcome Measures

Primary Outcomes (1)

• PSA response rate

  The proportion of subjects receiving at least one cycle of treatment with the study drug who had at least a 50% reduction in PSA from baseline and maintained it for more than 21 days (PSA50).

  24 months

Secondary Outcomes (3)

• ORR，Objective Response Rate

  24 months

• Overall survival (OS)

  From the first dose to death from any cause，up to two years.

• Progression free survival

  From the first dose to the first documentation of disease progression or death, up to two years.

Study Arms (1)

Disitamab Vedotin(RC48-ADC)

EXPERIMENTAL

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

Drug: Disitamab Vedotin（RC48-ADC）

Interventions

Disitamab Vedotin（RC48-ADC） DRUG

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

Also known as: RC48

Disitamab Vedotin(RC48-ADC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) Prostate cancer confirmed by histology;
• \) ≥ 18 years old;
• \) The presence of metastatic lesions confirmed by bone scan and/or CT/MRI and/or PET-CT;
• \) ECOG score 0-2;
• \) Continuously maintain ADT treatment and maintain testosterone levels ≤ 50ng/dL; The progression of prostate cancer recorded within 6 months prior to screening;
• \) Having received at least one NHT in the past before progressing;
• \) HER2 IHC 1+, 2+, or 3+;
• \) Inability to or refusal docetaxel chemotherapy;
• \) Voluntarily join the study;
• \) Expected survival time ≥ 6 months;
• \) Normal function of main organs;

You may not qualify if:

• )Have a history of malignant tumors other than prostate cancer;
• )Previously received allogeneic stem cell or parenchymal organ transplantation;
• \) Previously or currently suffering from congenital or acquired immunodeficiency diseases;
• \) 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;
• \) Other significant clinical and laboratory abnormalities that affect safety evaluation;
• \) Those who are unwilling or unable to take effective contraceptive measures;
• \) Subjects with active brain metastasis;

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead

Study Officials

• Shuo Wang, Doctor

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yudong Cao, Doctor

CONTACT

15110101301; ydcao@bjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2023
• First Posted: July 21, 2023
• Study Start: August 1, 2023
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2025
• Last Updated: July 21, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Determine after article publication
• Access Criteria: Determine after article publication