Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-25 @ 2:09 AM
NCT ID:
NCT07117760
Brief Summary:
PSMA is an ideal target for precision diagnosis and treatment of prostate cancer. LNC1011 is a novel albumin-binding PSMA-targeted radioligand. This study aims to explore the safety and efficacy of 225Ac-labeled LNC1011 for treating patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC).
Detailed Description:
Prostate-specific membrane antigen (PSMA)-targeted radioligand therapy has demonstrated promising potential in treating metastatic castration-resistant prostate cancer (mCRPC). Modification of PSMA radioligans with albumin-binding motifs prolonging blood circulation significantly enhances tumor uptake and therapeutic efficacy. LNC1011 incorporates dansylated amino acids as a novel, relatively weaker and superior albumin binder, achieving a refined balance between increased tumor accumulation, safety, and diagnostic performance. This enables a unified theranostic approach within a single molecular framework.
Alpha-emitting radionuclide therapeutics offer unique advantages for cancer treatment. Regarding tumoricidal effects: Alpha emitters generate alpha particles during decay, possessing a linear energy transfer (LET) nearly 100 times higher than beta emitters, resulting in significantly superior tumor eradication. Beta emitters primarily cause single-strand DNA breaks, potentially allowing tumor cell repair and recurrence. In contrast, alpha emitters directly induce irreparable double-strand DNA breaks, leading to permanent tumor cell kill. This has earned them the designation "surgical knife-like radiotherapy." Furthermore, clinical trial data indicate that alpha emitters can trigger tumor immune responses while killing cancer cells, demonstrating synergistic effects with immunotherapy and achieving a "1 + 1 \> 2" outcome in cancer therapy. Regarding safety: Alpha particles have an extremely short range (a few cell diameters), causing minimal damage to surrounding normal tissues with almost negligible side effects, thus offering superior safety. Actinium-225 has a half-life of 9.92 days. During this period, it decays through a series of alpha and beta decays, maximizing its therapeutic potential.
In this single-arm study, we will investigate the safety and efficacy of low-dose 225Ac-LNC1011 for the treatment of mCRPC. 225Ac-LNC1011 is administered at the dose of 3.7 MBq (+/- 10%), once every 8-10 weeks for a planned 4 cycles..
Post-Treatment Follow-up (Safety \& Efficacy): Following treatment cessation, all participants will undergo safety follow-up, including a 30-day safety follow-up visit (FUP) and longer-term safety follow-up assessments over approximately 12 months.
Survival Follow-up: After discontinuation of study treatment or completion of the post-treatment follow-up period, participant status will be collected every 90 days (through telephone) as part of survival follow-up. Every effort should be made to adhere to the survival follow-up schedule to ensure collection of survival data. Survival follow-up and the study will conclude when the number of OS events required for the final OS analysis is reached.
Study:
NCT07117760
Study Brief:
Protocol Section:
NCT07117760