NCT06139575

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P75+ for phase_1 prostate-cancer

Timeline
14mo left

Started Dec 2023

Geographic Reach
1 country

13 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress69%
Dec 2023Jul 2027

First Submitted

Initial submission to the registry

November 9, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 18, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

December 22, 2023

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Expected
Last Updated

May 13, 2025

Status Verified

May 1, 2025

Enrollment Period

2.4 years

First QC Date

November 9, 2023

Last Update Submit

May 8, 2025

Conditions

Prostate Cancer

Keywords

Prostate Cancer

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (16)

  • Radiation Dosimetry

    Up to 2 years follow up

  • Maximum plasma concentration (Cmax)

    Up to 2 years follow up

  • Time to maximum plasma concentration (Tmax)

    Up to 2 years follow up

  • Terminal elimination half-life (t1/2)

    Up to 2 years follow up

  • Total systemic clearance (CL)

    Up to 2 years follow up

  • +11 more secondary outcomes

Study Arms (1)

Lutetium Lu 177 JH020002 Injection

EXPERIMENTAL
Drug: Lutetium Lu 177 JH020002 Injection

Interventions

Lutetium Lu 177 JH020002 InjectionDRUG

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)

Lutetium Lu 177 JH020002 Injection

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Anhui Provincial Hospital

Hefei, Anhui, China

RECRUITING

Peking University First Hospital

Beijing, Beijing Municipality, China

RECRUITING

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

RECRUITING

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, China

RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, China

NOT YET RECRUITING

Huazhong University of Science and Technology Tongji Medical College Affiliated Union Hospital

Wuhan, Hubei, China

RECRUITING

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

RECRUITING

Affiliated Hospital of Jiangsu University

Wuxi, Jiangsu, China

NOT YET RECRUITING

Shandong Cancer Hospital

Jinan, Shandong, China

RECRUITING

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

West China Hospital of Sichuan University

Chengdu, Sichuan, China

RECRUITING

Tianjin Cancer Hospital Airport Hospital

Tianjin, Tianjin Municipality, China

RECRUITING

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Bivision Pharmaceuticals, Inc.

    Bivision Pharmaceuticals, Inc.

    STUDY DIRECTOR

Central Study Contacts

Bivision Pharmaceuticals, Inc.

CONTACT

86-21-50886996bivision.public1@bivisionpharma.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2023

First Posted

November 18, 2023

Study Start

December 22, 2023

Primary Completion

May 1, 2026

Study Completion (Estimated)

July 1, 2027

Last Updated

May 13, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will share

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.

Locations

CN(13)