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Also known as Antibody-Drug Conjugate (ADC), anti-CD46 antibody conjugate, FG-3246
FOR46 · 2 trials · 2 indications
A minimum of 3 patients will be treated at each dose level. If \< 33%of patients (i.e. 0 of 3 patients, or 1 of 6 patients) within a cohort have a dose-limiting toxicity (DLT in Cycle 1, then enrollment of the next cohort may commence upon approval of Data and Safety Monitoring Committee. At any dose level, dose escalation will be discontinued if \>= 2 of 3 to 6 patients within a cohort experience a DLT in Cycle 1, the MTD will have been exceeded. The previous dose level will then be considered the MTD if 6 patients were previously evaluated at this dose level. If this dose level was previously evaluated with 3 patients, then 3 additional patients will be enrolled at this dose level; if 0 or 1 of the additional 3 patients experiences a DLT in Cycle 1, then this dose level will be considered the MTD.
Dose-limiting toxicities classified using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0will be tabulated by dose level and reported in descriptive fashion.
Composite response is defined as a \>= 50% decline from baseline PSA (defined by Cycle 1 Day 1 value), confirmed by repeat measurement \>= 4 weeks later AND/OR objective tumor response by RECIST 1.1 criteria The composite response rate along with 95% confidence interval will be reported
| 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. |
| Does Escalation | EXPERIMENTAL | Approximately 3 dose levels of FOR46 will be evaluated. Participants will receive a lead-in treatment period of enzalutamide monotherapy for 14 days (day -14 to day -1), followed by addition of FOR46 on Cycle 1 Day 1. If participants are on enzalutamide at the time of study entry, and remain on continuous dosing at 160 mg daily, the lead-in treatment period will not be required. Prophylactic Pegfilgrastim (G-CSF) 6mg, subcutaneously (SQ) will also be administered on Day 2 during all treatment cycles. Pegfilgrastim could be modified to a lower dose of 3 mg with treating investigator approval. |
| Dose Expansion | EXPERIMENTAL | Participants will receive a lead-in treatment period of enzalutamide monotherapy for 14 days (day -14 to day -1), followed by addition of FOR46 on Cycle 1 Day 1, at the maximum tolerated dose (MTD) as determined in Phase 1b. If participants are on enzalutamide at the time of study entry, and remain on continuous dosing at 160 mg daily, the lead-in treatment period will not be required. Prophylactic Pegfilgrastim (G-CSF) 6mg, subcutaneously (SQ) will also be administered on Day 2 during all treatment cycles. Pegfilgrastim could be modified to a lower dose of 3 mg with treating investigator approval. |
| Name | Type | Description |
|---|---|---|
| FG-3246 | DRUG | FG-3246 will be administered per schedule specified in the arm description. |
| FOR46 | BIOLOGICAL | Given intravenously (IV) |
| Enzalutamide | BIOLOGICAL | Given orally (PO) |
| Pegfilgrastim | DRUG | Given subcutaneously (subQ) |
| Blood Samples | PROCEDURE | Blood samples will be taken for correlative studies |
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...
FOR46 is an investigational monoclonal antibody being studied for the treatment of metastatic castration-resistant prostate cancer. It is currently in Phase 1 clinical development and is being evaluated in combination with enzalutamide in patients with this disease.
FOR46 targets CD46, a protein that is expressed on the surface of cancer cells. By binding to CD46, the antibody is designed to direct an immune response against the tumor. This mechanism is being investigated in the context of metastatic castration-resistant prostate cancer.
FOR46 is being developed by Kyntra Bio, Inc., a biopharmaceutical company. The company is conducting a Phase 1 clinical trial of FOR46 in combination with enzalutamide for patients with metastatic castration-resistant prostate cancer.
FOR46 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 1 trial is studying the safety and efficacy of FOR46 in combination with enzalutamide in metastatic castration-resistant prostate cancer.
FOR46 is being studied in a Phase 1 clinical trial with the identifier NCT05011188. This trial is evaluating FOR46 in combination with enzalutamide in patients with metastatic castration-resistant prostate cancer. The study is active but not recruiting and is being conducted in the United States.