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Also known as [177Lu]Lu-PSMA-617
Lu-PSMA-617 · 3 trials · 4 indications
Study is feasible if at least 1 PSMA-PET positive lesion is identified in at least 50% of the participants in this cohort
Confirmed Overall Response Rate (ORR) is defined as the proportion of participants with Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR). ORR is based on PCWG3-modified RECIST v1.1 response for patients with measurable disease at baseline.
Radiographic progression free survival (rPFS) is defined as the time of radiographic progression by Prostate Cancer Working Group 3 (PCWG3)-modified RECIST V1.1 as assessed by blinded independent central review, or death.
| Arm | Type | Description |
|---|---|---|
| Lu-PSMA-617 | EXPERIMENTAL | Participants will receive 177Lu-PSMA-617 7.4 GBq (200 mCi) once every 6 weeks. 177Lu-PSMA-617 is a radiopharmaceutical which will be administered intravenously (IV). |
| [177Lu]Lu-PSMA-617 plus best supportive/best standard of care (BS/BSOC) | EXPERIMENTAL | Patients will receive the investigational product 7.4 GBq (+/- 10%) 177Lu-PSMA-617 intravenously every 6 weeks (+/- 1 week) for a maximum of 6 cycles. Best supportive/best standard of care (BS/BSOC) may be used |
| [177Lu]Lu-PSMA-617 | EXPERIMENTAL | Participants will receive 7.4 GBq (200 mCi) +/- 10% \[177Lu\]Lu-PSMA-617 once every 6 weeks for 6 cycles. Best supportive care, including ADT may be used. |
| Androgen receptor-directed therapy (ARDT) | ACTIVE_COMPARATOR | For participants randomized to the ARDT arm, the change of ARDT treatment will be administered per the physician's orders. Best supportive care, including ADT may be used. |
| Name | Type | Description |
|---|---|---|
| Lu-PSMA-617 | DRUG | Given IV |
| [177Lu]Lu-PSMA-617 | DRUG | Administered intravenously once every 6 weeks (1 cycle) for a maximum of 6 cycles. |
| Best supportive/best standard of care (BS/BSOC) | OTHER | Best supportive/best standard of care as defined by the local investigator |
| 68Ga-PSMA-11 | DRUG | Administered single intravenous dose of approximately 150 MBq. Administered dose could not be lower than 111 MBq or higher than 259 MBq (3 - 7 mCi). |
| ARDT | DRUG | administered orally on a continuous basis, as per package insert and guidelines |
| [68Ga]Ga-PSMA-11 | DRUG | single intravenous dose of approximately 150 MBq. Administered dose must not be lower than 111 MBq or higher than 259 MBq (3 - 7 mCi). |
| Best supportive care | OTHER | Best supportive/best standard of care as defined by the local investigator |
Inclusion Criteria: * Participants must have histologically, cytologically or radiographically confirmed hepatocellular carcinoma by LI-RADS30 with metastatic and/or unresectable disease. * Participants must have received one prior line of systemic therapy for the treatment of metastatic and/or unr...
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Lu-PSMA-617, also known as [177Lu]Lu-PSMA-617, is an investigational small molecule being studied for metastatic castration-resistant prostate cancer (mCRPC) and liver cancer, specifically hepatocellular carcinoma. It is a radioligand therapy that targets PSMA, an antigen expressed on prostate cancer cells, and is being evaluated in Phase 2 clinical trials.
Lu-PSMA-617 targets PSMA, which stands for prostate-specific membrane antigen, a cell surface protein highly expressed on prostate cancer cells. By binding to PSMA, the drug delivers a radioactive payload (lutetium-177) directly to the tumor, potentially causing cell death while sparing normal tissues. This mechanism is being investigated in PSMA-positive mCRPC and liver cancer.
Lu-PSMA-617 is being developed by Novartis AG, a global pharmaceutical company traded on the New York Stock Exchange under the ticker NVS. Novartis is conducting clinical trials for this radioligand therapy in multiple oncology indications, including metastatic castration-resistant prostate cancer and liver cancer.
Lu-PSMA-617 is currently in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing and completed trials are evaluating its efficacy and safety in patients with metastatic castration-resistant prostate cancer and liver cancer, with a total of 125 participants enrolled across studies.
Lu-PSMA-617 is being studied in three Phase 2 trials. NCT05658003 is an active, not recruiting study in Chinese men with progressive mCRPC. NCT05670106 is a completed study in Chinese men with PSMA-positive mCRPC. NCT06852820 is a recruiting study in the United States for metastatic hepatocellular carcinoma, using 68Ga-PSMA-11 PET-directed radioligand therapy.
Yes, Lu-PSMA-617 and [177Lu]Lu-PSMA-617 refer to the same drug. The latter is the full chemical notation indicating the lutetium-177 isotope attached to the PSMA-617 molecule. Both names are used interchangeably in clinical trial documentation and research publications.