Evaluating the Safety and Efficacy of 177Lu-LNC1011 Injection in a Single-Center, Single-Arm, Open Study in Patients with Prostate-Specific Membrane Antigen (PSMA)-Positive Metastatic Desmoplasia-Resistant Prostate Cancer

Affiliated Hospital of Jiangnan University

Status: Completed

Conditions: PSMA PET-Positive Castration-Resistant Prostate Cancer

Treatments: Drug: 177Lu-LNC1011

Study type: Interventional

Funder types: Other

Identifiers

NCT06809426

LS2023057

Details and patient eligibility

About

Evaluating the safety and antitumor efficacy of 177Lu-LNC1011

Full description

This is a prospective, single-center, single-arm, open IIT clinical study evaluating the safety and anti-tumor efficacy of 177Lu-LNC1011 Injection in patients with PSMA-positive metastatic desmoplasia-resistant prostate cancer (mCRPC). Thirteen patients are expected to be enrolled. Subjects will be required to sign an informed consent form prior to screening, and successful screened subjects will be treated with 177Lu-LNC1011 Injection as 75 mCi (2.78 GBq) intravenously every 6 weeks for a total of no more than 6 doses during the treatment period. Subjects will be monitored for safety and anti-tumor efficacy after dosing during the treatment period.

Enrollment: 13 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. ≥18 years old, male.
2. histologically or cytologically defined prostate cancer, the patients have not been treated or have exhausted all treatment.
3. meet the Prostate Cancer Working Group 3 (PCWG3) diagnosis of metastatic desmoplasia-resistant prostate cancer (mCRPC), including: a) the presence of a desmoplasia level of serum testosterone (serum testosterone <50 ng/dL or 1.7 nmol/L); b) and the presence of one of the following: - serum PSA progression: PSA >1 ng/mL and 2 consecutive rises in PSA 1 week apart, 2 greater than 50% of the nadir; or a bone scan suggestive of ≥2 new bone lesions; or CT or MRI suggestive of progression of soft tissue lesions (RECIST 1.1).
4. a physical status score of ≤2 according to Eastern Cooperative Oncology Group (ECOG) criteria.
5. PSMA positivity confirmed by 68Ga -PSMA PET/CT.

Exclusion criteria

Patients who did not meet the requirements as assessed by the investigator.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 1 patient group

177Lu-LNC1011

Experimental group

Description:

Successfully screened subjects will be treated with 177Lu-LNC1011 Injection during the treatment period with 75 mCi (2.78 GBq) intravenously every 6 weeks for a total of no more than 6 doses. Subjects will be monitored for safety and anti-tumor efficacy after dosing during the treatment period.

Treatment:

Drug: 177Lu-LNC1011