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

NCT06250244 | Recruiting Phase 1

• 1 other identifier: PUMCH-NM-PSMA1011
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Metastatic Castration-resistant Prostate Cancer

Keywords

PSMA; 177Lu; mCRPC

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (2)

• PSA Response

  through study completion, an average of 6 months

• Pharmacokinetics and dosimetry

  Whole-body (WB) scans were performed at 2, 4, 24, 48, 72, 120, and 168 hours following intravenous administration of [177Lu]Lu-LNC1011

Study Arms (1)

LNC1011 Dose escalation

EXPERIMENTAL

Patients received a single dose of 1.85 GBq (50 mCi) of 177Lu-LNC1011 via intravenous injection, followed by monitoring at 3, 24, 48, 72, and 168 hours post-injection. Subsequent cohorts received a dose escalation of 0.925 GBq from the previous cohort.

Drug: 177Lu-LNC1011

Interventions

177Lu-LNC1011 DRUG

\[177Lu\]Lu-LNC1011 is a novel long-circulating PSMA therapeutic probe.

LNC1011 Dose escalation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

Study Officials

• Zhaohui Zhu, MD

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhaohui Zhu, MD

CONTACT

86-13611093752; 13611093752@163.com

Jiarou Wang, MD

CONTACT

86-13269163729; ChristinaWang97@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2024
• First Posted: February 9, 2024
• Study Start: May 1, 2023
• Primary Completion: April 1, 2025
• Study Completion: October 1, 2025
• Last Updated: December 11, 2024

Record last verified: 2024-02

Locations

CN (1)