Clinical Evaluation of 177Lu-DansyI-PSMA (LNC1011) in Pat... | NCT06377683

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Dosimetry	Dosimetry, measured as absorbed dose in tumor and normal organs (Gy/GBq), was estimated in the first treatment cycle for each patient.	At the end of Cycle 1 (each cycle is 42 days)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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