A Phase 2a Study with Safety Run-in to Evaluate the Safety Tolerability and Preliminary Efficacy of FF-10832 Monotherapy or in Combination with Pembrolizumab in Patients with Advanced Solid Tumors
Are you eligible to participate in this study?
You may be eligible for this study if you meet the following criteria:
-
Conditions: Urothelial Cancer
-
Age: Between 18 Year(s) - 100 Year(s)
-
Gender: Male or Female
-
Other Inclusion Criteria:
- In the Safety Run-in, patients with histologically or cytologically confirmed advanced or metastatic solid tumors who have disease progression after treatment with standard therapies for metastatic disease that are known to confer clinical benefit, or are intolerant to treatment or refuse standard treatment
- For the Disease-Specific Expansion Cohorts, patients with histologically or cytologically confirmed diagnosis of urothelial cancer (UC), or non-small cell lung cancer (NSCLC) who have disease progression after standard therapy, including PD-1/L1 treatment, for metastatic disease. Progression on PD-1/PD-L1 treatment
- Patients with histologically or cytologically confirmed diagnosis of UC may have had up to 3 prior therapies with or without a maintenance component
You may not be eligible for this study if the following are true:
-
- Has received prior systemic anticancer therapy including investigational agents within 4 weeks (or 5 half-lives, whichever is shorter) prior to treatment
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-programmed cell death ligand 2 (PDL2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA4, OX 40, CD137), AND was discontinued from that treatment due to a Grade 3 or higher immune-related adverse event (irAE)
- Has received prior radiotherapy within 2 weeks of start of study treatment or have had a history of radiation pneumonitis
If you are registered as a volunteer, please log in to contact the study team/express interest in this study.