177Lu-LNC1011 in Patients With Metastatic Castration-resistant Prostate Cancer

Metastatic Castration-resistant Prostate Cancer Clinical Trial

Official title:

Phase 1 Trial Assessing Safety, Maximum Tolerated Dose, and Patient-Specific Dosimetry of [177Lu]Lu-LNC1011 in Metastatic Castration-Resistant Prostate

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06250244
• Other study ID #: PUMCH-NM-PSMA1011
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: October 1, 2024

Study information

• Verified date: February 2024
• Source: Peking Union Medical College Hospital
• Contact: Zhaohui Zhu, MD
• Phone: 86-13611093752
• Email: 13611093752[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study employed an open-label, non-randomized design, representing the first human trial of its kind. It utilized a standard 3+3 dose-escalation approach, focusing on patients with metastatic castration-resistant prostate cancer, initiating treatment at a dose of 1.85 GBq over a 6-week period. Subsequent cohorts underwent sequential 50% dose escalations until the observation of dose-limiting toxicity (DLT).

Description:

[177Lu]Lu-LNC1011 is a novel long-circulating PSMA therapeutic probe. This study represents the first human investigation, aiming to explore its maximum tolerated dose (MTD), safety, dosimetry, and initial treatment efficacy in patients with metastatic castration-resistant prostate cancer (mCRPC).This study employed an open-label, non-randomized design, representing the first human trial of its kind. It utilized a standard 3+3 dose-escalation approach, focusing on patients with metastatic castration-resistant prostate cancer, initiating treatment at a dose of 1.85 GBq over a 6-week period. Subsequent cohorts underwent sequential 50% dose escalations until the observation of dose-limiting toxicity (DLT).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 9
• Est. completion date: October 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• progressive metastatic castration-resistant prostate cancer

• tumors with high PSMA expression confirmed on 68Ga-PSMA PET/CT PSMA expression confirmed on 68Ga-PSMA PET/CT

Exclusion Criteria:

• a serum creatinine level of more than 150 µmol per liter

• a hemoglobin level of less than 10.0 g/dl

• a white-cell count of less than 4.0× 109/L

• a platelet count of less than 100 × 109/L

• a total bilirubin level of more than 3 times the upper limit of the normal range

• a serum albumin level of more than 3.0 g per deciliter

• cardiac insufficiency

Related Conditions & MeSH terms

• Metastatic Castration-resistant Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• 177Lu-LNC1011
[177Lu]Lu-LNC1011 is a novel long-circulating PSMA therapeutic probe.

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dosimetry of normal organs and tumors	The semiquantitative dosimetry will be performed based on SPECT/CT acquisitions after the first administration of 177Lu-LNC1011. The dose delivered to normal organs and tumors will be recorded.	through study completion, an average of 4 weeks
Primary	Hematologic adverse events collection	Hematologic status were performed before and every 2 weeks after administration of radiopharmaceutical. Adverse events were categorized using the Common Toxicity Criteria for Adverse Events 5.0:Total white cell count less than 2.5 × 10^9/L,Platelet count less than 75 × 10^9/L	through study completion, an average of 6 months
Primary	Liver and renal toxic events collection	Liver and renal function were performed before and 4 weeks after administration of radiopharmaceutical. Adverse events were categorized using the Common Toxicity Criteria for Adverse Events 5.0:Progressive deterioration of organ function (GFR <30 mL/min or creatinine > 2-fold upper limit of normal (ULN); liver enzymes > 5-fold ULN).	through study completion, an average of 6 months
Secondary	PSA Response	The serum PSA response was documented semimonthly until 6 weeks after the administration of 177Lu-LNC1011. PSA response was classified as the following: partial response (PR) if PSA decrease =50%, progressive disease (PD) if PSA increase = 25% and stable disease (SD) if PSA increase <25% or PSA decrease <50%.	through study completion, an average of 6 months