A Phase 1/2 Study of 177Lu-NYM032 Injection in mCRPC

A Phase 1/2 Study to Evaluate the Safety, Pharmacokinetics, Radiation Dosimetry and Efficacy of 177Lu-NYM032 Injection in Patients With PSMA-Positive Metastatic Castration-Resistant Prostate Cancer

177Lu-NYM032 injection is a radioligand therapeutic agent that targets prostate specific membrane antigen (PSMA)-expressing prostate tumors. NYM032 is a small molecular with strong affinity for PSMA.

Study Overview

• Status: Active, not recruiting
• Conditions: Metastatic Castration-resistant Prostate Cancer
• Intervention / Treatment: Drug: 177Lu-NYM032 injection

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Wuxi, China, 214000
    • Affliated Hospital of Jiangnan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ≥18 years;
2. Histologically or cytologically confirmed adenocarcinoma of prostate；
3. Documented progressive metastatic CRPC based on Prostate Cancer Working Group 3(PCWG3) criteria, which includes at least one of the following criteria: a.PSA progression;b.Objective radiographic progression in soft tissue; c.New bone lesions
4. Have serum testosterone < 50 ng/dL;
5. Patients with significant PSMA avidity on 68Ga-NYM032 PET/CT；
6. ECOG score of 0 or 1；
7. Expected life≥ 6 months;
8. Patients must have received at least one NAAD；
9. Patients must have received taxane-based chemotherapy or not be candidates for taxane chemotherapy；
10. Patients must have adequate organ and marrow function；
11. The subjects agree to take effective contraceptive measures during the study period and for at least three months after the drug administration:
12. The subjects are able to maintain good communication with the researchers, understand and follow the requirements of this study, voluntarily participate, and sign an informed consent form before the start of relevant research operations.

Exclusion Criteria:

1. Previous treatment with any of the following within 6 months before enrollment: Strontium-89,Samarium-153,Rhenium-186,Rhenium-188, Radium-223,hemi-body irradiation. Previous PSMA-targeted radioligand therapy is not allowed;
2. Any systemic anti-cancer therapy(e.g.chemotherapy, immunotherapy or biological therapy [including monoclonal antibodies]) within 28 days prior to day of enrollment;
3. Site(s) of disease that are FDG positive with minimal PSMA expression ;
4. Any investigational agents within 28 days prior to day of enrollment;
5. Known hypersensitivity to the components of the 177Lu-NYM032 or its analogs;
6. Other concurrent investigational therapy;
7. Transfusion for the sole purpose of making a subject eligible for study inclusion;
8. Patients with a history of Central Nervous System (CNS) metastases must have received therapy (surgery, radiotherapy, gamma knife) and be neurologically stable,asymptomatic, and not receiving corticosteroids for the purposes of maintaining neurologic integrity, Patients with epidural disease, canal disease and prior cord involvement are eligible if those areas have been treated, are stable, and not neurologically impaired. For patients with parenchymal CNS metastasis (or a history of CNS metastasis), baseline and subsequent radiological imaging must include evaluation of the brain (MRI preferred or CT with contrast);
9. A superscan as seen in the baseline bone scan;
10. Symptomatic cord compression, or clinical or radiologic findings indicative of impending cord compression;
11. Concurrent serious (as determined by the Principal Investigator) medical conditions that in the opinion of the investigator would impair study participation or cooperation;
12. Diagnosed with other malignancies that are expected to alter life expectancy or may interfere with disease assessment. However, patients with a prior history of malignancy that has been adequately treated and who have been disease free for more than 3 years are eligible, as are patients with adequately treated non-melanoma skin cancer, superficial bladder cancer;
13. Eligible for treatment(s) other than ARDT based on the presence of any mutations or biomarkers that are known as predictors of better response (e.g., AR-V7 or BRCA).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 177Lu-NYM032 injection	Drug: 177Lu-NYM032 injection; Radionuclide 177Lu will be used as a therapeutic nuclide for this study. The precursor of NYM032 will be labeled with 177Lu to form the chelation product, 177Lu-NYM032 injection which will be used in this study as a intravenous injection dose of 177Lu-NYM032. The radiation dose is chosen within the range of 50-200 mCi for an individual patient at every dose.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients With Dose Limiting Toxicity (DLT)	Dose limiting toxicity is determined by monitoring for adverse events following therapy.	28 days
Maximum Tolerated Dose (MTD)	Maximum tolerated dose (MTD) is determined by monitoring dose-limiting toxicity and adverse events in the dosing cohorts	28 days

Collaborators and Investigators

• Sponsor: Norroy Bioscience Co., LTD
• Investigators: Principal Investigator: Chunjing Yu, Affiliated Hospital of Jiangnan University

Study record dates

Study Major Dates

• Study Start (Actual): April 26, 2024
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: April 17, 2024
• First Submitted That Met QC Criteria: April 22, 2024
• First Posted (Actual): April 25, 2024

Study Record Updates

• Last Update Posted (Actual): May 21, 2025
• Last Update Submitted That Met QC Criteria: May 20, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: CP-2023-04; NYM032Z01 (Other Identifier: National Medical Products Administration)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No