| Eligibility |
Inclusion Criteria:
- Male and female patients =18 years of age.
- Able and willing to comply with protocol-specified requirements and to provide written
informed consent.
- Patients must have histologically confirmed muscle-invasive bladder cancer (MIBC;
T2-T4a, N0, M0 per American Joint Commission on Cancer [AJCC]) pure or mixed histology
urothelial carcinoma [urothelial carcinoma should be the dominant histology].
- The initial TURBT that showed muscularis propria invasion should be within 12 weeks
prior to beginning study therapy.
- Patients must have sufficient baseline tumor tissue from either initial or repeat
TURBTs for submission of at least 20 unstained slides for translational study
objectives. Patients with available unstained slides <20 may be considered on a
case-by-case basis after discussion with the Sponsor (Note: An FFPE tissue block(s)
may also be acceptable.
- Patients must be ineligible for cisplatin-based chemotherapy.
- Patients must be a candidate for radical cystectomy (RC) and planned to undergo RC per
their treating physician
- C-reactive protein (CRP) level =5 mg/L
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Adequate organ function.
- Fully vaccinated against COVID-19 at least 4 weeks before the start of Screening
activities. If under consideration for a booster, the booster administration needs to
be complete within the same time constraint (ie, at least 4 weeks before the start of
Screening activities).
- Adequate contraception for Men and Women or practice abstinence as well as refrain
from donating sperm during the treatment period and for at least 180 days after the
last dose of study treatment.
- Women may participate if not pregnant or breastfeeding.
Exclusion Criteria:
- Prior systemic therapy for muscle invasive UCB/MIBC
- Prior radiation therapy for muscle invasive UCB/MIBC
- Intravesical therapy within 6 weeks of Day 1 of trial
- Malignancies other than MIBC/muscle invasive UCB within 2 years prior to Day 1 of this
trial, with the exception of those with a negligible risk of metastasis or death and
with expected curative outcome (such as adequately treated carcinoma in situ of the
cervix, basal or squamous cell skin cancer, localized prostate cancer treated
surgically with curative intent, or ductal carcinoma in situ treated surgically with
curative intent) or undergoing active surveillance per standard-of-care management
(e.g., chronic lymphocytic leukemia Rai Stage 0, prostate cancer with Gleason score =
6, and prostate specific antigen [PSA] = 10 mg/mL, etc.)
- Currently participating in or has participated in a trial of an investigational agent
within 4 weeks prior to the first dose of study treatment or 5 half-lives, whichever
is longer without recovery of clinically significant toxicities from that therapy.
- Known severe hypersensitivity (CTCAE v5.0, Grade =3) to FL-101, its active substance,
or any of its excipients.
- Known history of human immunodeficiency virus or active Hepatitis B or Hepatitis C
infection.
- Symptomatic herpes zoster within the past 30 days, a serious bacterial infection
within the past 6 months or have had other recent or ongoing signs of infections.
- Received a live or attenuated vaccine within 30 days prior to the first dose of study
treatment.
- Clinically unstable disease in any organ system despite current therapy, including,
but not limited to ongoing or active infection including tuberculosis, symptomatic
congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric
illness/social situations.
- Use of illicit drugs or excess intake of alcohol, based on the judgement of the
Investigator.
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