---
title: Phase 1/2 Clinical Study of Lutetium Lu 177 JH020002 Injection in Patients With Advanced Prostate Cancer
nct_id: NCT06139575
overall_status: RECRUITING
phase: PHASE1, PHASE2
sponsor: Bivision Pharmaceuticals, Inc.
study_type: INTERVENTIONAL
primary_condition: Prostate Cancer
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06139575.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06139575"
ct_last_update_post_date: 2025-05-13
last_seen_at: "2026-05-12T07:14:41.585Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Phase 1/2 Clinical Study of Lutetium Lu 177 JH020002 Injection in Patients With Advanced Prostate Cancer

**Official Title:** 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

**NCT ID:** [NCT06139575](https://clinicaltrials.gov/study/NCT06139575)

## Key Facts

- **Status:** RECRUITING
- **Phase:** PHASE1, PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 90
- **Lead Sponsor:** Bivision Pharmaceuticals, Inc.
- **Conditions:** Prostate Cancer
- **Start Date:** 2023-12-22
- **Completion Date:** 2027-07
- **CT.gov Last Update:** 2025-05-13

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** MALE
- **Healthy Volunteers:** No

```
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.
```

## Arms

- **Lutetium Lu 177 JH020002 Injection** (EXPERIMENTAL)

## Interventions

- **Lutetium Lu 177 JH020002 Injection** (DRUG) — 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)

## Primary Outcomes

- **Dose Limiting Toxicity (DLT) (Phase 1)** _(time frame: Up to 2 years follow up)_ — Incidence of adverse events, serious adverse events, and clinical laboratory abnormalities defined as dose-limiting toxicities (DLTs).
- **Maximum Tolerated Dose (MTD) (Phase 1)** _(time frame: Up to 2 years follow up)_ — The maximum tolerated dose is among the explored dose levels.
- **Recommended Phase 2 Dose (RP2D) (Phase 1)** _(time frame: Up to 2 years follow up)_ — To identify the expansion phase dose of Lutetium Lu 177 JH020002 Injection.
- **PSA response rate** _(time frame: Up to 3 years follow up)_ — 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.

## Secondary Outcomes

- **Radiation Dosimetry** _(time frame: Up to 2 years follow up)_
- **Maximum plasma concentration (Cmax)** _(time frame: Up to 2 years follow up)_
- **Time to maximum plasma concentration (Tmax)** _(time frame: Up to 2 years follow up)_
- **Terminal elimination half-life (t1/2)** _(time frame: Up to 2 years follow up)_
- **Total systemic clearance (CL)** _(time frame: Up to 2 years follow up)_
- **Area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC0-t)** _(time frame: Up to 2 years follow up)_
- **Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC0-inf)** _(time frame: Up to 2 years follow up)_
- **Volume of distribution (Vz) during the terminal phase following intravenous elimination** _(time frame: Up to 2 years follow up)_
- **Radiographic Progression-free Survival (rPFS)** _(time frame: Up to 3 years follow up)_
- **Disease control Rate (DCR)** _(time frame: Up to 3 years follow up)_
- **Duration of Response (DoR)** _(time frame: Up to 3 years follow up)_
- **Time to First Subsequent Therapy (TFST)** _(time frame: Up to 3 years follow up)_
- **Overall Survival (OS)** _(time frame: Up to 3 years follow up)_
- **Time to Symptomatic Skeletal Event (TTSSE)** _(time frame: Up to 3 years follow up)_
- **Incidence and severity of Adverse Events (AEs) and Serious Adverse Event (SAEs)** _(time frame: Up to 3 years follow up)_
- **Objective Response Rate (ORR) (Phase 2)** _(time frame: Up to 2 years follow up)_

## Locations (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, 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_

## Recent Field Changes (last 30 days)

- `locations.west china hospital of sichuan university|chengdu|sichuan|china` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `locations.tianjin cancer hospital airport hospital|tianjin|tianjin municipality|china` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.anhui provincial hospital|hefei|anhui|china` — added _(2026-05-12)_
- `locations.peking university first hospital|beijing|beijing municipality|china` — added _(2026-05-12)_
- `locations.the first affiliated hospital of fujian medical university|fuzhou|fujian|china` — added _(2026-05-12)_
- `locations.sun yat-sen university cancer center|guangzhou|guangdong|china` — added _(2026-05-12)_
- `locations.henan cancer hospital|zhengzhou|henan|china` — added _(2026-05-12)_
- `locations.huazhong university of science and technology tongji medical college affiliated union hospital|wuhan|hubei|china` — added _(2026-05-12)_
- `locations.the first affiliated hospital of soochow university|suzhou|jiangsu|china` — added _(2026-05-12)_
- `locations.affiliated hospital of jiangsu university|wuxi|jiangsu|china` — added _(2026-05-12)_
- `locations.shandong cancer hospital|jinan|shandong|china` — added _(2026-05-12)_
- `locations.fudan university shanghai cancer center|shanghai|shanghai municipality|china` — added _(2026-05-12)_
- `locations.zhejiang provincial people's hospital|hangzhou|zhejiang|china` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT06139575.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT06139575*  
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