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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Metastatic Castration-resistant Prostate Cancer
• Intervention / Treatment: Drug: Disitamab Vedotin（RC48-ADC）

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Yudong Cao, Doctor; Phone Number: 15110101301; Email: ydcao@bjmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Disitamab Vedotin(RC48-ADC); Disitamab Vedotin(RC48-ADC) :2.0mg/kg，Q2W	Drug: Disitamab Vedotin（RC48-ADC）; Participants will receive RC48-ADC intravenous injection (2.0 mg/kg, Q2W) until disease progression or death.; Other Names: RC48

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
ORR，Objective Response Rate	The proportion of patients who achieved patial response and complete reponse.	24 months
Overall survival (OS)	median OS or OS rate	From the first dose to death from any cause，up to two years.
Progression free survival	median PFS or PFS rate	From the first dose to the first documentation of disease progression or death, up to two years.

Collaborators and Investigators

• Sponsor: Peking University Cancer Hospital & Institute
• Investigators: Principal Investigator: Shuo Wang, Doctor, Peking University Cancer Hospital & Institute

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2023
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: July 13, 2023
• First Submitted That Met QC Criteria: July 13, 2023
• First Posted (Actual): July 21, 2023

Study Record Updates

• Last Update Posted (Actual): July 21, 2023
• Last Update Submitted That Met QC Criteria: July 13, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: HER2; RC48-ADC; metastasis Castration Resistant Prostate Cancer
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms; Physiological Effects of Drugs; Immunologic Factors; Immunoconjugates; Disitamab vedotin
• Other Study ID Numbers: RCVDTYPEC053

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Article publication
• IPD Sharing Time Frame: Determine after article publication
• IPD Sharing Access Criteria: Determine after article publication
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No