Clinical Evaluation of 177Lu-DansyI-PSMA (LNC1011) in Patients With Metastatic Castration-Resistant Prostate Cancer

NCT06377683 | Completed Phase 1

• 1 other identifier: XMYY-2023KY122
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

Ten to 20% of patients with prostate cancer (PC) experience progression in their disease, even after undergoing pharmaceutical or surgical castration, leading to metastatic CRPC (mCRPC). Prostate-specific membrane antigen (PSMA) is a membrane-bound glycoprotein mostly specific to the prostate. While PSMA is expressed at low levels in normal prostate, this expression increased by 100-1000-fold in PC, which makes it a favorable target for therapy. This study was designed to evaluate the safety, tolerability, and maximum tolerated dose of a long-lasting radiolabeled ligand 177Lu-Dansyl-PSMA in mCRPC patients.

Conditions

Metastatic Castration-resistant Prostate Cancer, mCRPC

Keywords

mCRPC; radioligand therapy; PSMA; 177Lu-DansyI-PSMA

Outcome Measures

Primary Outcomes (2)

• Incidence of treatment-related adverse events (safety and tolerability)

  Number of participants with treatment-related adverse events as assessed by CTCAE v5.0. Dose-limiting toxicity was defined as any 177Lu-Dansyl-PSMA-related AE ≥ grade 3 (G3).

  At the end of Cycle 2 (each cycle is 42 days)

• To determine the maximum tolerated dose (MTD)

  The MTD is the dose level below that which 2 out of 6 subjects in a cohort have DLT

  At the end of Cycle 2 (each cycle is 42 days)

Secondary Outcomes (1)

• Dosimetry

  At the end of Cycle 1 (each cycle is 42 days)

Study Arms (1)

177Lu-Dansyl-PSMA

EXPERIMENTAL

177Lu-Dansyl-PSMA A maximum of 2 cycles of 50 mCi (1.85 GBq) 177Lu-Dansyl-PSMA, each. Route of administration: Slow intravenous infusion/injection (i.v.) Duration of treatment: 2 cycles, every 6 weeks. Subsequent cohorts received an incremental 50% dose increase until dose-limiting toxicity (DLT) was observed.

Drug: 177Lu-Dansyl-PSMA radioligand therapy

Interventions

177Lu-Dansyl-PSMA radioligand therapy DRUG

Radioligand therapy using 177Lu-Dansyl-PSMA 50mCi (1.85GBq) will performed 6-weekly. A maximum of 2 cycles will be administered, and subsequent cohorts receive an incremental 50% dose increase until dose-limiting toxicity (DLT) was observed.

177Lu-Dansyl-PSMA

Eligibility Criteria

• Age: 21 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to understand and willingness to sign a written informed consent document.
• Age 21 and older
• Confirmed unresectable PC that is refractory to or has progressed following prior treatments.
• Confirmed unresectable PC with measurable disease per RECIST (version 1.1) (i.e. at least 1 lesion \> 1 cm or lymph node \> 1.5 cm in short axis)
• Patients must have a castrate level of serum/plasma testosterone (\< 50 ng/dL or \< 1.7 nmol/L).
• Eastern Cooperative Oncology Group Performance Status ≤ 3
• Participant must have completed prior therapy at least 2 weeks (washout period) before 68Ga-PSMA PET/CT scan. Any clinically significant toxicity (with the exceptions of hair loss and sensory neuropathy) related to prior therapy resolved below Grade 2 or baseline. Completion of entry into 68Ga-PSMA study and completion of the scan
• Patients must be 68Ga-PSMA PET/CT scan positive.
• Hematologic parameters defined as:
• Absolute neutrophil count (ANC) ≥ 1000 cells/mm3 Platelet count ≥ 50,000/mm3 Hemoglobin ≥ 8 g/dL
• Blood chemistry levels defined as:
• AST, ALT, alkaline phosphatase ≤ 5 times upper limit of normal (ULN) Total bilirubin ≤ 3 times ULN Creatinine ≤ 3 times ULN Able to remain motionless for up to 30-60 minutes per scan

You may not qualify if:

• Participant on any chemical anticoagulant including antiplatelet agents (excluding ASA)
• Participants with Class 3 or 4 NYHA Congestive Heart Failure
• Clinically significant bleeding within two weeks before trial entry (e.g. gastrointestinal bleeding, intracranial bleeding)
• Major surgery, defined as any surgical procedure that involves general anesthesia and a significant incision (i.e. larger than what is required for placement of a central venous access, percutaneous feeding tube, or biopsy) within 28 days before study day 1 or anticipated surgery within the subsequent 6 weeks
• Has an additional active malignancy requiring therapy within the past 2 years
• Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
• Psychiatric illness/social situations that would interfere with compliance with study requirements
• Cannot undergo PET/CT scanning because of weight limits (350 lbs)
• INR\>1.2; PTT\>5 seconds above UNL

Sponsors & Collaborators

• The First Affiliated Hospital of Xiamen University: lead

Study Sites (1)

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, 361003, China

Location

Study Officials

• Haojun Chen, MD, PhD

  The First Affiliated Hospital of Xiamen University

  STUDY CHAIR

Study Design

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

Model Details: classic 3+3 dose escalation

Study Record Dates

• First Submitted: April 17, 2024
• First Posted: April 22, 2024
• Study Start: April 5, 2024
• Primary Completion: March 27, 2025
• Study Completion: March 27, 2025
• Last Updated: April 1, 2025

Record last verified: 2025-03

Locations

CN (1)