Muscle Invasive Bladder CarcinomaEarly Phase 1NCT05395260
FL- 101 Study in Non-Metastatic MIBC
A Early Phase 1 study testing FL-101 in people with Muscle Invasive Bladder Carcinoma, run by Flame Biosciences.
Trial summary
A pilot window of opportunity study of FL-101 in patients with non-metastatic MIBC who are eligible for radical cystectomy (RC) but are ineligible for, or decline, cisplatin-based neoadjuvant therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Muscle Invasive Bladder Carcinoma
- What is being tested?
- FL-101
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 22 Aug 2022to 28 Dec 2022
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
About this study
Official title: A Pilot Window of Opportunity Trial: FL-101 in Non-Metastatic Muscle Invasive Bladder Cancer
A pilot window of opportunity study of FL-101 in patients with non-metastatic MIBC who are eligible for radical cystectomy (RC) but are ineligible for, or decline, cisplatin-based neoadjuvant therapy.
Read the detailed description
This is a pilot window of opportunity study of FL-101 in patients with non-metastatic MIBC who are eligible for radical cystectomy (RC) but are ineligible for, or decline, cisplatin-based neoadjuvant therapy.
The target recruitment will be 5 evaluable patients, with a possible expansion. Eligible patients will be enrolled to receive two doses of FL-101 prior to RC. FL-101 will be administered intravenously (IV) every two weeks (i.e., on Day 1 and Day 15).
Safety will be assessed by monitoring and recording all TEAEs graded by the NCI CTCAE v.5.0. In addition, laboratory assessments (hematology, serum chemistry, coagulation, and urinalysis), vital signs, physical exams, and 12-lead electrocardiogram (ECG) findings will be used to evaluate the safety of FL-101.
The PK of FL-101 will be characterized by analyzing samples collected at the time points.
To assess the immunogenicity of FL-101, ADAs will be measured as indicated in the Schedule of Assessments.
- Conditions
- Muscle Invasive Bladder Carcinoma
- Being tested
- FL-101
- Keywords
- Bladder Cancer
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FL-101Drug
FL-101 200mg IV
| Study group | Role | What they receive |
|---|---|---|
| FL-101-IV | Experimental | Open Label Infusion of FL-101 on Day 1 and Day 15 Receives: Drug: FL-101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of FL-101 on CRP
Evaluate the post-treatment changes in CRP from baseline
Measured: Screening visit through 4 weeks post surgery day
Secondary outcomes (3)
The incidence of treatment emergent adverse events
Safety and tolerability will be evaluated by incidence rate of treatment emergent adverse events of baseline.
Measured: Day 1 through up to 6 weeks post surgery day
Episodes of serious adverse events in patients with MIBC treated with FL-101
Safety and tolerability will be evaluated by the severity of treatment emergent adverse events of baseline.
Measured: Day 1 through up to 6 weeks post surgery day
Evaluate the concentration of FL-101 in whole blood
Measure of concentration of FL-101 in whole blood at specific timepoints
Measured: Day 1 through up to 6 weeks post surgery day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2022
- Study start22 Aug 2022 (estimated)
- Primary completion28 Nov 2022 (estimated)
- Study completion28 Dec 2022 (estimated)
Why it stopped: Sponsor Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle Invasive Bladder CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Flame Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Matthew Galsky, MD, Principal investigator, Icahn School of Medicine at Mount SinaiSumanta Kumar Pal, MD, Principal investigator, City of Hope Comprehensive Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05395260
- Sponsor's protocol ID
- FL-101-1003
- Status last verified
- Aug 2022
- First submitted
- 19 May 2022
- Last updated
- 19 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Window of Opportunity Trial: FL-101 in Non-Metastatic Muscle Invasive Bladder Cancer
- ClinicalTrials.gov ID
- NCT05395260
- Acronym / sponsor ID
- FL-101-1003
- Conditions
- Muscle Invasive Bladder Carcinoma
- Keywords
- Bladder Cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor Decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Flame BiosciencesIndustry (pharma, biotech, devices)
- Study start
- 22 Aug 2022 (estimated)
- Primary completion
- 28 Nov 2022 (estimated)
- Study completion
- 28 Dec 2022 (estimated)
- First posted
- 27 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A pilot window of opportunity study of FL-101 in patients with non-metastatic MIBC who are eligible for radical cystectomy (RC) but are ineligible for, or decline, cisplatin-based neoadjuvant therapy.
Detailed description
This is a pilot window of opportunity study of FL-101 in patients with non-metastatic MIBC who are eligible for radical cystectomy (RC) but are ineligible for, or decline, cisplatin-based neoadjuvant therapy.
The target recruitment will be 5 evaluable patients, with a possible expansion. Eligible patients will be enrolled to receive two doses of FL-101 prior to RC. FL-101 will be administered intravenously (IV) every two weeks (i.e., on Day 1 and Day 15).
Safety will be assessed by monitoring and recording all TEAEs graded by the NCI CTCAE v.5.0. In addition, laboratory assessments (hematology, serum chemistry, coagulation, and urinalysis), vital signs, physical exams, and 12-lead electrocardiogram (ECG) findings will be used to evaluate the safety of FL-101.
The PK of FL-101 will be characterized by analyzing samples collected at the time points.
To assess the immunogenicity of FL-101, ADAs will be measured as indicated in the Schedule of Assessments.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FL-101-IV | Experimental | Drug: FL-101Open Label Infusion of FL-101 on Day 1 and Day 15 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FL-101FL-101 200mg IV | Drug | FL-101-IV |
Primary outcome
Effect of FL-101 on CRP
Time frame: Screening visit through 4 weeks post surgery day
Evaluate the post-treatment changes in CRP from baseline
3 secondary outcomes
The incidence of treatment emergent adverse events
Time frame: Day 1 through up to 6 weeks post surgery day
Episodes of serious adverse events in patients with MIBC treated with FL-101
Time frame: Day 1 through up to 6 weeks post surgery day
Evaluate the concentration of FL-101 in whole blood
Time frame: Day 1 through up to 6 weeks post surgery day
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2022.
- Individual participant dataSharing planned: No
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Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew Galsky, MD principal investigator
Icahn School of Medicine at Mount Sinai
Sumanta Kumar Pal, MD principal investigator
City of Hope Comprehensive Center
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing FL-101 in people with Muscle Invasive Bladder Carcinoma, run by Flame Biosciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of FL-101 on CRP (time frame: Screening visit through 4 weeks post surgery day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2022.