Targeted Radionuclide Therapy in Metastatic Prostate Cancer Using a New PSMA Ligand Radiolabelled With Terbium-161 (161Tb-SibuDAB) - Dose Identification/Escalation Phase Ia/b Study

Researchers will test a new treatment for prostate cancer. This treatment uses an antibody tagged with a small amount of radioactive material. Researchers believe the new antibody might work better than those used before.
In the first part of the study researchers will compare the new treatment to the old one on prostate cancer patients using very low doses, not strong enough to treat nor to cause strong adverse reactions. Each patient will eventually receive both treatments, but one at a time.
The aim of the second part of the study is to find the best dose of the new treatment for patients. This means finding the dose that offers the most benefits with the fewest side effects.
The performance of different prostate cancer diagnostic methods is also in scope of the study.

开始日期2024-02-20

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100 项与 [161Tb]Tb-SibuDAB 相关的临床结果

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100 项与 [161Tb]Tb-SibuDAB 相关的转化医学

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100 项与 [161Tb]Tb-SibuDAB 相关的专利（医药）

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项与 [161Tb]Tb-SibuDAB 相关的文献（医药）

2025-04-01·European Journal of Nuclear Medicine and Molecular Imaging

First-in-human administration of [161Tb]Tb-SibuDAB and comparative dosimetry with standard [177Lu]Lu-PSMA-I&T as part of the PROGNOSTICS phase Ia study

Article

作者: McDougall, Lisa ; Müller, Cristina ; Schmid, David E ; Westerbergh, Frida ; Tschan, Viviane J ; Aceto, Nicola ; Geistlich, Susanne ; van der Meulen, Nicholas P ; Busslinger, Sarah D ; Chirindel, Alin ; Bernhardt, Peter ; Fokkema, Angelique ; Wild, Damian ; Schibli, Roger ; Nicolas, Guillaume P

We present results from the first patient in the PROGNOSTICS (NCT06343038) Phase Ia study, a prospective, single-center, single-blind trial aiming to translate [161Tb] Tb-SibuDAB to clin. radioligand therapy (RLT).In Phase Ia of the PROGNOSTICS study, mCRPC patients with stable disease on [177Lu]Lu-PSMA-I&T RLT receive two test injections: 1 GBq [177Lu]Lu-PSMA-I&T and 1 GBq [161Tb]Tb-SibuDAB, administered 3 wk apart in random order.Quant. SPECT/CT imaging was performed at 3, 24, 48, and 168 h post-injection.Tumor and organ absorbed doses were computed using a 75 keV±10% window for 161Tb (low-energy high-resolution collimator) and a 208 keV±10% window for 177Lu (mediumenergy low-penetration collimator), using a Monte Carlo OSEM reconstruction algorithm.Safety and acute toxicity (CTCAE 5.0) along with transcriptional "omics" and circulating tumor cells were evaluated after each test injection.First-in-human data suggest [161Tb]Tb-SibuDAB is a promising radiopharmaceutical for the current indication of RLT in mCRPC.The potential to enhance treatment durability against micrometastases could be further explored in a neo/adjuvant setting.The planned dose escalation study (Phase Ib of PROGNOSTICS) will assess the efficacy, toxicity, and therapeutic index of [161Tb]Tb-SibuDAB.

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
转移性去势抵抗性前列腺癌	临床1期	瑞士	-	2024-02-20
转移性前列腺癌	临床1期	瑞士	-	2024-02-20
PSMA阳性去势抵抗性前列腺癌	临床1期	瑞士	-	2024-02-20

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


PROGNOSTICS (SNMMI2026)	临床1期	转移性去势抵抗性前列腺癌	6	[161Tb]Tb-SibuDAB (3.0 GBq)	夢膚糧糧願選築網餘蓋(簾範積齋壓顧繭蓋觸廠) = entry dose (3.0 GBq): anemia (n=1), thrombocytopenia (n=1), leukopenia (n=1) and lymphopenia (n=1). 4.5 GBq dose level: anemia (n=1), thrombocytopenia (n=2), leukopenia (n=1), neutropenia (n=1) and lymphopenia (n=1). In both cohorts, there were grade 3 leukopenia (n=2, one each cohort) and no grade 4/5 hematologic toxicity. 積鏇簾蓋蓋鹹遞蓋壓蓋 (鏇窪廠窪膚鹹獵製壓鑰 ) 更多	积极	2026-05-27
				[161Tb]Tb-SibuDAB (4.5 GBq)