Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Lutetium (177Lu) rhPSMA-10.1 Injection
Lutetium rhPSMA-10.1 · 1 trial · 6 indications
Incidence of DLTs during the DLT observation period.
Frequency and nature of treatment-emergent adverse events (TEAEs).
The number of subjects with an anti-tumour response defined as ≥50% reduction in PSA level from baseline to the end of treatment.
| Arm | Type | Description |
|---|---|---|
| Phase 1, Cohort A | EXPERIMENTAL | Subjects with PSMA positive disease will receive 5.55GBq of 177Lu-rhPSMA-10.1 (maximum of 3 cycles). |
| Phase 1, Cohort B | EXPERIMENTAL | Subjects with PSMA positive disease will receive 7.4GBq of 177Lu-rhPSMA-10.1 (maximum of 3 cycles). |
| Phase 2, Cohort 2A | EXPERIMENTAL | Subjects with PSMA positive disease will receive 2 doses at 10.00 GBq (270 mCi) followed by up to 5 additional doses at 7.40 GBq (200 mCi), all doses administered at 6-weekly intervals. |
| Phase 2, Cohort 2B | EXPERIMENTAL | Subjects with PSMA positive disease will receive up to 8 doses at 7.40 GBq (200 mCi). The first 3 doses will be administered at 3-weekly intervals, with the remaining doses being administered at 6-weekly intervals. |
| Phase 2, Cohort 2C (optional) | EXPERIMENTAL | If opened, subjects with PSMA positive disease will receive 2 doses at 14.80 GBq (400 mCi) followed by up to 4 additional doses at 7.40 GBq (200 mCi), all doses administered at 6-weekly intervals. |
| Name | Type | Description |
|---|---|---|
| Lutetium (177Lu) rhPSMA-10.1 Injection | DRUG | Therapeutic cycles of 177Lu-rhPSMA-10.1 |
| 18F-rhPSMA-7.3 injection (in phase 1 only) | DIAGNOSTIC_TEST | 18F-rhPSMA-7.3 (in phase 1 only) at an administered activity of 296 MBq (8 mCi) for PET/CT scan to ascertain whether the subject has PSMA-positive disease. |
Inclusion Criteria: 1. Male subjects, 18 years of age or older with histologically confirmed adenocarcinoma of the prostate. 2. Serum testosterone levels \<50 ng/dL (1.73 nmol/L) after surgical or continued chemical castration. 3. Presence of disease target or non target lesions (per RECIST v1.1) o...
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Lutetium rhPSMA-10.1 is an investigational small molecule being studied for the treatment of prostate cancer, including metastatic castration-resistant prostate cancer (mCRPC). It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.
Lutetium rhPSMA-10.1 is a radiopharmaceutical that targets prostate-specific membrane antigen (PSMA), a protein highly expressed on prostate cancer cells. By binding to PSMA, it delivers a radioactive payload (lutetium-177) directly to the tumor cells.
Lutetium rhPSMA-10.1 is being developed by cbdMD, Inc., a company traded on the stock exchange under the ticker symbol YCBD. The company is conducting clinical trials to evaluate the drug's safety and efficacy in prostate cancer.
Lutetium rhPSMA-10.1 is currently in Phase 1 clinical trials. It is an investigational drug, meaning it has not yet received FDA approval and is still undergoing clinical development to assess its safety and effectiveness.
Lutetium rhPSMA-10.1 is being studied in a Phase 1 trial with the identifier NCT05413850, titled 'Anti-tumour Activity of (177Lu) rhPSMA-10.1 Injection'. This trial is recruiting 82 male participants aged 18 and older with prostate cancer, including mCRPC, and is being conducted in the United States, Belgium, Germany, Netherlands, and the United Kingdom.
Yes, Lutetium rhPSMA-10.1 is also known as Lutetium (177Lu) rhPSMA-10.1 Injection. These names refer to the same investigational drug being developed for prostate cancer.