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

Bivision Pharmaceuticals, Inc.13 sites in 1 country90 target enrollmentDecember 22, 2023

ConditionsProstate Cancer

InterventionsLutetium Lu 177 JH020002 Injection

DrugsLutetium Lu 177 JH020002 Injection

Overview

Phase: Phase 1
Intervention: Lutetium Lu 177 JH020002 Injection
Conditions: Prostate Cancer
Sponsor: Bivision Pharmaceuticals, Inc.
Enrollment: 90
Locations: 13
Primary Endpoint: Dose Limiting Toxicity (DLT) (Phase 1)
Status: Recruiting
Last Updated: 11 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 22, 2023

End Date

July 2027

Last Updated

11 months ago

Study Type

Interventional

Study Design

Sequential

Sex

Male

Investigators

Sponsor

Bivision Pharmaceuticals, Inc.

Responsible Party

Sponsor

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 -
•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 & Interventions

Lutetium Lu 177 JH020002 Injection

Intervention: Lutetium Lu 177 JH020002 Injection

Outcomes

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

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