Drugs / 177Lu-PSMA-I&T
177Lu-PSMA-I&T
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT04886986 | Jun 2021 → Dec 2027 expected | prostate cancer | Weill Medical College of Cornell University | Recruiting | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT05896371 | Mar 2028 → Mar 2033 expected | metastatic malignant neoplasm, metastatic prostate carcinoma | CHU de Quebec-Universite Laval | Not yet recruiting | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT04188587 | Jan 2019 → Aug 2020 | castration-resistant prostate carcinoma | Nanjing First Hospital, Nanjing Medical University | Unknown | No outcome recorded |
| Phase 31 trial · 1 met primary | ||||||
| Phase 3 | NCT05204927 | Feb 2022 → Aug 2024 overdue | metastatic prostate carcinoma | Curium US LLC | Active not recruiting | Met primary |
| Comparator or background therapy2 trials | ||||||
| Phase 1 | NCT07316686 Background | Jun → Sep 2026 overdue | prostate adenocarcinoma | Cancer Institute of the State of São Paulo | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT06343038 Comparator | Feb 2024 → Jun 2028 expected | castration-resistant prostate carcinoma | University Hospital, Basel, Switzerland | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2026-02-26 | Curium US LLC | Results Curium Announces Pharmacokinetics and Dosimetry Data for Investigational Lutetium-177 Zadavotide Guraxetan in Metastatic Castration-Resistant Prostate Cancer at ASCO GU 2026 curiumpharma.com ↗
Curium, a world leading nuclear medicine company dedicated to using cutting-edge technology and innovative science to personalize diagnoses and treatments for patients with cancer, today announced the first dosimetry and pharmacokinetics (PK) data from a substudy of the ongoing pivotal Phase 3 ECLIPSE clinical trial (NCT05204927). |
| 2026-01-07 | Curium US LLC | Regulatory Curium’s Investigational New Drug Application Accepted by Center for Drug Evaluation in China curiumpharma.com ↗
Curium Shanghai Pharmaceuticals Co., Ltd. (科锐霖（上海）医药有限公司), has had its Investigational New Drug (IND) Application for 177 Lu-PSMA-I&T, a therapeutic agent for patients with metastatic castration-resistant prostate cancer (mCRPC), accepted by the Centre for Drug Evaluation (CDE) which is now under review. |
| 2024-11-13 | Curium US LLC | Results Curium Announces ECLIPSE Trial Has Met Primary Endpoint, Demonstrating a Statistically Significant and Clinically Meaningful Benefit for Patients With PSMA-Positive Metastatic Castration Resistant Prostate Cancer curiumpharma.com ↗
The ECLIPSE trial demonstrated a statistically significant and clinically meaningful improvement in the median radiographic progression-free survival (rPFS) of patients with prostate-specific membrane antigen (PSMA) positive metastatic castration-resistant prostate cancer (mCRPC) after treatment with up to 6 doses of 200 mCi (7.4 GBq) of 177 Lu-PSMA-I&T in patients previously treated with an androgen receptor pathway inhibitor (ARPI) compared to a change in ARPI. |
| 2021-10-27 | Curium US LLC | Regulatory Curium Initiates ECLIPSE, a Phase 3 Clinical Trial For Its Investigational Lu 177 PSMA I&T curiumpharma.com ↗
Curium is working closely with sites across the U.S. to initiate the ECLIPSE trial (A Multi-Center, Open-Label, Randomized Phase 3 Trial Comparing the Safety and Efficacy of 177Lu-PSMA-I&T versus Hormone Therapy in Patients with Metastatic Castration-Resistant Prostate Cancer). |
All press releases naming this drug 10 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 6 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | 177Lu-PSMA-I&T | “177Lu-PSMA-I&T” NCT07316686 ↗ |
| Known as | 177Lu-PSMA | “Lutetium-177 (177Lu)-PSMA (LuPSMA) is a novel and highly targeted systemic RLT for progressive mCRPC.” NCT04188587 ↗ |
| Known as | LuPSMA | “Lutetium-177 (177Lu)-PSMA (LuPSMA) is a novel and highly targeted systemic RLT for progressive mCRPC.” NCT04188587 ↗ |
| Known as | Lutetium 177Lu-PSMA-I&T | “This is a prospective, open-label, multi-center, randomized, Phase 3 study evaluating Lutetium 177Lu-PSMA-I&T as treatment compared to standard of care hormone therapy in men...” NCT05204927 ↗ |
| Known as | PSMA-I＆T | “177 Lu -labeled PSMA ligand(PSMA-I＆T)” NCT04188587 ↗ |
| Modality | Other / unclassified | “Lutetium-177 (177Lu)-PSMA (LuPSMA) is a novel and highly targeted systemic RLT for progressive mCRPC.” NCT04188587 ↗ |
| Route | Intravenous | “All patients were intravenous injected with single dose 2.0-8.0 GBq.” NCT04188587 ↗ |