Clinical trial NCT06139575: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Lead sponsor: Bivision Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2023-11-18
Enrollment: 90
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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 criteria: 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.

Primary outcomes:
measure: Dose Limiting Toxicity (DLT) (Phase 1)
timeFrame: Up to 2 years follow up
measure: Maximum Tolerated Dose (MTD) (Phase 1)
timeFrame: Up to 2 years follow up
measure: Recommended Phase 2 Dose (RP2D) (Phase 1)
timeFrame: Up to 2 years follow up
measure: PSA response rate
timeFrame: Up to 3 years follow up
Secondary outcomes:
measure: Radiation Dosimetry
timeFrame: Up to 2 years follow up
measure: Maximum plasma concentration (Cmax)
timeFrame: Up to 2 years follow up
measure: Time to maximum plasma concentration (Tmax)
timeFrame: Up to 2 years follow up
measure: Terminal elimination half-life (t1/2)
timeFrame: Up to 2 years follow up
measure: Total systemic clearance (CL)
timeFrame: Up to 2 years follow up
measure: Area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC0-t)
timeFrame: Up to 2 years follow up
measure: Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC0-inf)
timeFrame: Up to 2 years follow up
measure: Volume of distribution (Vz) during the terminal phase following intravenous elimination
timeFrame: Up to 2 years follow up
measure: Radiographic Progression-free Survival (rPFS)
timeFrame: Up to 3 years follow up
measure: Disease control Rate (DCR)
timeFrame: Up to 3 years follow up
measure: Duration of Response (DoR)
timeFrame: Up to 3 years follow up
measure: Time to First Subsequent Therapy (TFST)
timeFrame: Up to 3 years follow up
measure: Overall Survival (OS)
timeFrame: Up to 3 years follow up
measure: Time to Symptomatic Skeletal Event (TTSSE)
timeFrame: Up to 3 years follow up
measure: Incidence and severity of Adverse Events (AEs) and Serious Adverse Event (SAEs)
timeFrame: Up to 3 years follow up
measure: Objective Response Rate (ORR) (Phase 2)
timeFrame: Up to 2 years follow up
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Provincial Hospital
state: Anhui
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Fuzhou
country: China
facility: The First Affiliated Hospital of Fujian Medical University
state: Fujian
city: Guangzhou
country: China
facility: Sun Yat-Sen University Cancer Center
state: Guangdong
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Wuhan
country: China
facility: Huazhong University of Science and Technology Tongji Medical College Affiliated Union Hospital
state: Hubei
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
state: Jiangsu
city: Wuxi
country: China
facility: Affiliated Hospital of Jiangsu University
state: Jiangsu
city: Jinan
country: China
facility: Shandong Cancer Hospital
state: Shandong
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Cancer Hospital Airport Hospital
state: Tianjin
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital
state: Zhejiang
Study officials:
affiliation: Bivision Pharmaceuticals, Inc.
name: Bivision Pharmaceuticals, Inc.
role: STUDY_DIRECTOR
References: