Phase 1/2 Clinical Study of Lutetium Lu 177 JH020002 Injection in Patients With Advanced Prostate Cancer

Phase 1/2 Clinical Study to Evaluate the Safety, Tolerability, Radiation Dosimetry and Preliminary Efficacy of Lutetium Lu 177 JH020002 Injection in Patients With Advanced Prostate Cancer

The study is being conducted to evaluate the safety, tolerability, pharmacokinetics, radiation dosimetry, and preliminary efficacy of Lutetium Lu 177 JH020002 Injection in adult patients with advanced prostate cancer.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: Lutetium Lu 177 JH020002 Injection

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Bivision Pharmaceuticals, Inc.; Phone Number: 86-21-50886996; Email: bivision.public1@bivisionpharma.com

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China
      • Recruiting
      • Anhui Provincial Hospital
  • Beijing
    • Beijing, Beijing, China
      • Recruiting
      • Peking University First Hospital
  • Fujian
    • Fuzhou, Fujian, China
      • Recruiting
      • The First Affiliated Hospital Of Fujian Medical University
  • Guangdong
    • Guangzhou, Guangdong, China
      • Recruiting
      • Sun yat-sen University Cancer Center
  • Henan
    • Zhengzhou, Henan, China
      • Not yet recruiting
      • Henan Cancer Hospital
  • Hubei
    • Wuhan, Hubei, China
      • Recruiting
      • Huazhong University of Science and Technology Tongji Medical College Affiliated Union Hospital
  • Jiangsu
    • Suzhou, Jiangsu, China
      • Recruiting
      • The First Affiliated Hospital of Soochow University
    • Wuxi, Jiangsu, China
      • Not yet recruiting
      • Affiliated Hospital of Jiangsu University
  • Shandong
    • Jinan, Shandong, China
      • Recruiting
      • Shandong Cancer Hospital
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Fudan University Shanghai Cancer Center
      • Contact: Dingwei Ye, M.D.; Phone Number: +8613701663571; Email: fuscc2012@163.com
      • Contact: Shaoli Song, M.D.; Phone Number: +8613816608573; Email: shaoli-song@163.com
  • Sichuan
    • Chengdu, Sichuan, China
      • Recruiting
      • West China Hospital of Sichuan University
  • Tianjin
    • Tianjin, Tianjin, China
      • Recruiting
      • Tianjin Cancer Hospital Airport Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Recruiting
      • Zhejiang Provincial People's Hospital

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Subjects are required to get informed consent prior to the trial and sign a written informed consent form voluntarily.
• Male, age ≥18 years.
• ECOG score 0 - 2.
• Must have a life expectancy >6 months.
• Histologically and/or cytologically confirmed adenocarcinoma of the prostate (except for those with neuroendocrine or small cell prostate cancer clinical features).
• Participants must have a castrate level of serum/plasma testosterone (< 50 ng/dl, or < 1.7nmol/L).

Exclusion Criteria:

• Diagnosed with other malignancies, apart from: adequately treated skin basal cell carcinoma or superficial bladder cancers from which the patient has been disease-free for more than 3 years as confirmed by a physician.
• Participants with a history of central nervous system (CNS) metastases who are neurologically unstable, symptomatic, or receiving corticosteroids for the purpose of maintaining neurologic integrity.
• Previous treatment with Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223 or hemi-body irradiation <6 months prior to date of first administration of investigational drug.
• Previous PSMA-targeted radioligand therapy.
• Previous radiotherapy for prostate cancer within 4 weeks prior to date of first administration of investigational drug.
• Any systemic anti-cancer therapy (e.g. chemotherapy, immunotherapy, poly adenosine diphosphate-ribosyl polymerase inhibitors (PARPi) or biological therapy within 4 weeks prior to date of first administration of investigational drug.
• Must not take part in other investigational therapies within 4 weeks prior to date of first administration of investigational drug.
• History of hypersensitivity to any of the study drugs or its excipients or to drugs of similar chemical classes.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lutetium Lu 177 JH020002 Injection	Drug: Lutetium Lu 177 JH020002 Injection; Patients will receive Lutetium Lu 177 JH020002 Injection every 6 weeks for a maximum of 6 doses. Doses range between 1.85 and 8.88 GBq (50-240 mCi)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dose Limiting Toxicity (DLT) (Phase 1)	Incidence of adverse events, serious adverse events, and clinical laboratory abnormalities defined as dose-limiting toxicities (DLTs).	Up to 2 years follow up
Maximum Tolerated Dose (MTD) (Phase 1)	The maximum tolerated dose is among the explored dose levels.	Up to 2 years follow up
Recommended Phase 2 Dose (RP2D) (Phase 1)	To identify the expansion phase dose of Lutetium Lu 177 JH020002 Injection.	Up to 2 years follow up
PSA response rate	PSA response rate is the proportion of PSA responders, defined as a participant who has achieved PSA decrease of >= 50% from baseline that is confirmed by a second consecutive PSA measurement >= 4 weeks later. Determination of response status will be based on PCWG3 recommendations.	Up to 3 years follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR) (Phase 2)	Proportion of participants with Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR). ORR was based on the Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria response for patients with measurable disease at baseline.	Up to 2 years follow up
Radiation Dosimetry	Absorbed dose estimated in organs and tumor lesions.	Up to 2 years follow up
Maximum plasma concentration (Cmax)	Pharmacokinetics (PK) characterization of Lutetium Lu 177 JH020002.	Up to 2 years follow up
Time to maximum plasma concentration (Tmax)	Pharmacokinetics (PK) characterization of Lutetium Lu 177 JH020002.	Up to 2 years follow up
Terminal elimination half-life (t1/2)	Pharmacokinetics (PK) characterization of Lutetium Lu 177 JH020002.	Up to 2 years follow up
Total systemic clearance (CL)	Pharmacokinetics (PK) characterization of Lutetium Lu 177 JH020002.	Up to 2 years follow up
Area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC0-t)	Pharmacokinetics (PK) characterization of Lutetium Lu 177 JH020002.	Up to 2 years follow up
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC0-inf)	Pharmacokinetics (PK) characterization of Lutetium Lu 177 JH020002.	Up to 2 years follow up
Volume of distribution (Vz) during the terminal phase following intravenous elimination	Pharmacokinetics (PK) characterization of Lutetium Lu 177 JH020002.	Up to 2 years follow up
Radiographic Progression-free Survival (rPFS)	Radiographic progression free survival (rPFS) is defined as the time of radiographic progression by Prostate Cancer Working Group 3 (PCWG3)-modified RECIST V1.1.	Up to 3 years follow up
Disease control Rate (DCR)	Disease control rate (DCR) is defined as the proportion of participants with best overall response of complete response or partial response or Stable disease in soft tissue according to PCWG3 modified RECIST 1.1.	Up to 3 years follow up
Duration of Response (DoR)	Duration of response (DOR) is defined as the duration of time between the date of first documented response (CR or PR) in soft tissue as per BIRC and according to PCWG3 modified RECIST 1.1, and the date of first documented progression or death due to any cause.	Up to 3 years follow up
Time to First Subsequent Therapy (TFST)	Time to First Subsequent Therapy (TFST) is defined as the time from the date of first administration of investigational drug to the date of the first subsequent therapy of the prostate cancer.	Up to 3 years follow up
Overall Survival (OS)	Overall survival (OS) is defined as the time from the date of first administration of investigational drug to the date of death due to any cause.	Up to 3 years follow up
Time to Symptomatic Skeletal Event (TTSSE)	Time to a first symptomatic skeletal event (TTSSE) is defined as date of first administration of investigational drug to the date of first new symptomatic pathological bone fracture, spinal cord compression, tumor-related orthopedic surgical intervention, requirement for radiation therapy to relieve bone pain or death from any cause, whichever occurs first.	Up to 3 years follow up
Incidence and severity of Adverse Events (AEs) and Serious Adverse Event (SAEs)	Analysis of frequencies and severity for Adverse Events (AEs) and Serious Adverse Event (SAEs), through the monitoring of relevant clinical and laboratory safety parameters.	Up to 3 years follow up

Collaborators and Investigators

• Sponsor: Bivision Pharmaceuticals, Inc.
• Investigators: Study Director: Bivision Pharmaceuticals, Inc., Bivision Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 22, 2023
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: November 9, 2023
• First Submitted That Met QC Criteria: November 14, 2023
• First Posted (Actual): November 18, 2023

Study Record Updates

• Last Update Posted (Actual): May 13, 2025
• Last Update Submitted That Met QC Criteria: May 8, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Prostate Cancer
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: JH020002-01C

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Bivision Pharmaceuticals, Inc. is committed to sharing with qualified external researchers access to patient-level data. These sharing requests are reviewed and approved by Bivision Pharmaceuticals, Inc subject to certain criteria and conditions. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No