Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
FG-3246 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| FG-3246 1.8 mg/kg | EXPERIMENTAL | Participants will receive FG-3246 1.8 milligrams (mg)/kilogram (kg) administered via intravenous (IV) infusion on Day 1 of each 21-day treatment cycle (every 3 weeks \[Q3W\]) until radiographic progression, unacceptable safety and tolerability, participant or investigator decision to stop treatment, other withdrawal criteria are met, or sponsor decision to close the study. |
| FG-3246 2.4 mg/kg | EXPERIMENTAL | Participants will receive FG-3246 2.4 mg/kg administered via IV infusion on Day 1 of each 21-day treatment cycle (Q3W) until radiographic progression, unacceptable safety and tolerability, participant or investigator decision to stop treatment, other withdrawal criteria are met, or sponsor decision to close the study. |
| FG-3246 2.7 mg/kg | EXPERIMENTAL | Participants will receive FG-3246 2.7 mg/kg administered via IV infusion on Day 1 of each 21-day treatment cycle (Q3W) until radiographic progression, unacceptable safety and tolerability, participant or investigator decision to stop treatment, other withdrawal criteria are met, or sponsor decision to close the study. |
| Name | Type | Description |
|---|---|---|
| FG-3246 | DRUG | FG-3246 will be administered per schedule specified in the arm description. |
Key Inclusion Criteria: * Participant must have histological, and/or cytological confirmation of prostate adenocarcinoma on all prior tumor biopsies. * Participant with soft tissue disease and a safely accessible soft tissue tumor lesion(s) must agree to biopsy of a primary or metastatic lesion dur...
FG-3246 is an investigational small molecule being developed for the treatment of metastatic castration-resistant prostate cancer (mCRPC). It is currently in Phase 2 clinical development and is being studied in a randomized, controlled trial in the United States.
FG-3246 targets CD46, a protein that is expressed on the surface of cancer cells. By binding to CD46, FG-3246 is designed to interfere with cancer cell survival and proliferation in metastatic castration-resistant prostate cancer.
FG-3246 is being developed by Kyntra Bio, Inc., a biopharmaceutical company. Kyntra Bio is listed on the stock exchange under the ticker symbol KYNB.
FG-3246 is currently in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. The ongoing Phase 2 trial is actively recruiting participants with metastatic castration-resistant prostate cancer.
FG-3246 is being evaluated in a Phase 2 clinical trial with the identifier NCT06842498. This trial is recruiting male participants aged 18 years and older with metastatic castration-resistant prostate cancer in the United States, with a planned enrollment of 75 participants.