Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
I-131-1095 · 1 trial · 5 indications
The percentage of participants with a PSA response according to PCWG3 criteria. PCWG3 defines PSA response as the first occurrence of a 50 percent or more decline in PSA from baseline, confirmed by a second measurement at least 3 weeks later.
| Arm | Type | Description |
|---|---|---|
| Enzalutamide | ACTIVE_COMPARATOR | Participants received the label dosage of enzalutamide once daily for up to 53 weeks. |
| I-131-1095 in combination with enzalutamide | EXPERIMENTAL | Participants received up to 4 (8-week) cycles of I-131-1095: 100 mCi for the first dose. Subsequent dose(s) were reduced to 75 mCi for participants experiencing any of the dose-limiting toxicities. The third and fourth therapeutic doses could be reduced to 75 mCi on the basis of dosimetry assessment after administration of 10 mCi of I-131-1095 prior to the third dosing cycle. Participants also received the label dosage of enzalutamide once daily for up to 53 weeks. |
| Name | Type | Description |
|---|---|---|
| I-131-1095 | DRUG | Participants received up to 4 (8-week) cycles of I-131-1095: 100 mCi for the first dose. Subsequent dose(s) were reduced to 75 mCi for participants experiencing any dose-limiting toxicities. The third and fourth therapeutic doses could be reduced to 75 mCi on the basis of dosimetry assessment after administration of 10 mCi of I-131-1095 prior to the third dosing cycle. Participants also received the label dosage of enzalutamide once daily for up to 53 weeks. |
| Enzalutamide | DRUG | Participants received the label dosage of enzalutamide once daily for up to 53 weeks. |
Inclusion Criteria: 1. Male ≥ 18 years of age 2. Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features at initial diagnosis 3. Castration-resistant prostate cancer, with serum testosterone ≤ 50 ng/dL at Screening 4. Ra...
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I-131-1095 is an investigational small molecule being studied for the treatment of metastatic prostate cancer, specifically metastatic castration-resistant prostate cancer (mCRPC) that has progressed during treatment with abiraterone. It is being evaluated in combination with enzalutamide in a Phase 2 clinical trial.
I-131-1095 is a radioligand therapy, meaning it delivers a radioactive isotope (I-131) to cancer cells. The specific molecular target of I-131-1095 has not been disclosed in the available information, so its precise mechanism of action is not detailed here.
I-131-1095 is being developed by Lantheus Holdings, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol LNTH. The company is conducting clinical research on this investigational agent for metastatic prostate cancer.
I-131-1095 is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. A Phase 2 trial has been completed, evaluating the drug in combination with enzalutamide for metastatic castration-resistant prostate cancer.
I-131-1095 has been studied in one completed Phase 2 clinical trial, identified as NCT03939689. This trial, known as ARROW, compared I-131-1095 plus enzalutamide versus enzalutamide alone in patients with metastatic castration-resistant prostate cancer that progressed during abiraterone treatment. The trial enrolled 120 participants in the United States and Canada.
I-131-1095 is an investigational radioligand therapy developed by Lantheus Holdings. No alternative names for this drug have been disclosed in the available information. It is distinct from other prostate cancer therapies such as enzalutamide and abiraterone, which are used as comparators or combination partners in its clinical trial.