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

Phase 2RecruitingNCT06139575

Bivision Pharmaceuticals, Inc.90 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Prostate Cancer

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)

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (13)

Anhui Provincial Hospital

Hefei, Anhui, China

RECRUITING

Peking University First Hospital

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

Dose Limiting Toxicity (DLT) (Phase 1)

Incidence of adverse events, serious adverse events, and clinical laboratory abnormalities defined as dose-limiting toxicities (DLTs).

Time frame: Up to 2 years follow up

Maximum Tolerated Dose (MTD) (Phase 1)

The maximum tolerated dose is among the explored dose levels.

Time frame: 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.

Time frame: 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.

Time frame: Up to 3 years follow up

Secondary Outcomes

Radiation Dosimetry

Absorbed dose estimated in organs and tumor lesions.

Time frame: Up to 2 years follow up

Maximum plasma concentration (Cmax)

Pharmacokinetics (PK) characterization of Lutetium Lu 177 JH020002.

Time frame: Up to 2 years follow up

Time to maximum plasma concentration (Tmax)

Pharmacokinetics (PK) characterization of Lutetium Lu 177 JH020002.

Time frame: Up to 2 years follow up

Central Contacts

Bivision Pharmaceuticals, Inc.

CONTACT

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

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

...and 3 more locations

Terminal elimination half-life (t1/2)

Pharmacokinetics (PK) characterization of Lutetium Lu 177 JH020002.

Time frame: Up to 2 years follow up

Total systemic clearance (CL)

Pharmacokinetics (PK) characterization of Lutetium Lu 177 JH020002.

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)

Pharmacokinetics (PK) characterization of Lutetium Lu 177 JH020002.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Up to 3 years follow up

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.

Time frame: Up to 2 years follow up