In short
Clinical trials are studying 177Lu-Rhpsma-10.1 in men with advanced prostate cancer, especially metastatic castration-resistant prostate cancer. These studies aim to assess safety, tolerability, dosing, and anti-tumor effects, and one trial compares it with another PSMA-targeted treatment.
Key points
- Clinical trials of 177Lu-Rhpsma-10.1 are studying advanced prostate cancer, mainly metastatic castration-resistant prostate cancer. One completed Phase 1 study compared it with another PSMA-targeted treatment and looked at the balance between tumor dose and kidney dose. Another authorized study includes Phase 1 and Phase 2 parts and focuses on safety, tolerability, and signs of anti-tumor activity. The main patient groups are men with mCRPC, including PSMA-positive disease. Key outcomes include dose-limiting toxicities, treatment-emergent adverse events, PSA response, and therapeutic index. These trials are designed to learn both how safe the treatment is and whether it may help control cancer.
Trial overview
Clinical trials of 177Lu-Rhpsma-10.1 are studying men with advanced prostate cancer, mainly metastatic castration-resistant prostate cancer (mCRPC), which means the cancer has spread and is no longer well controlled by hormone-lowering treatment.
Two interventional studies are listed: one completed Phase 1 study and one authorised study that includes Phase 1 and Phase 2 parts.
Who is being studied
The trials focus on men with advanced prostate cancer, especially those with PSMA-positive disease, which means the cancer shows a marker called PSMA that can help identify the right study group.
One study includes patients with PSMA-positive non-curative metastatic castration-resistant prostate cancer, while the other study includes men with metastatic castration-resistant prostate cancer (mCRPC).
Trial phases and study goals
Both studies are early clinical trials, and one of them also moves into Phase 2. Phase 1 usually focuses on safety, tolerability, and the study of the right treatment regimen, which means the way the treatment is given.
In the completed Phase 1 study, the main goal was to compare the therapeutic index of 177Lu-Rhpsma-10.1 with lutetium (177Lu) vipivotide tetraxetan (Pluvicto®). In the authorised study, Phase 1 aimed to find the recommended Phase 2 dose regimen by checking safety and tolerability, and Phase 2 aimed to evaluate efficacy, which means whether the treatment shows signs of helping against the cancer.
Main outcomes being measured
The completed study measured the ratio of tumor to kidney absorbed dose, which is a way to compare how much treatment reaches the cancer versus the kidney. This is called the therapeutic index.
The authorised study measured dose-limiting toxicities (serious side effects that can limit the dose), treatment-emergent adverse events (health problems that appear or worsen during treatment), and the number of patients with an anti-tumor response defined as a PSA drop of at least 50% by the end of treatment.
Summary of the trials
One study is already completed and enrolled 24 people, while the other is authorised and planned to enroll 112 people.
Together, these trials are designed to learn whether 177Lu-Rhpsma-10.1 is safe enough for further study and whether it may help control advanced prostate cancer.