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New treatment option for Advanced Urothelial Carcinoma
Official title A Study of FX-909 in Patients With Advanced Solid Malignancies, Including Advanced Urothelial Carcinoma
ClinicalTrials.gov ID: NCT05929235
What this study is testing
What is FX-909?
FX-909 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for advanced urothelial carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to study the safety and tolerability in all advanced solid tumors, including advanced urothelial carcinoma. The main question(s) it aims to answer are: Is FX-909 safe and tolerable, as a monotherapy and in combination with Pembrolizumab What is the right dose level for patients Participants will be asked to take FX-909 daily in tablet form, or FX-909 daily and Pembrolizumab every 3 weeks, and record any outcomes from taking the drug.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Part A/B
- Able to understand and willing to sign an informed consent.
- Age ≥ 18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.
- An archival, paraffin-embedded, formalin-fixed, tumor sample (see Laboratory Manual for details) that in Part A is no more than 30 months old at the...
You likely can't join if
- Female patients who are pregnant (confirmed with a positive pregnancy test) or breastfeeding.
- Prior anticancer chemotherapy or small molecule targeted therapy, either investigational or commercially approved and available, within 2 weeks or 5...
- Prior therapy directly inhibiting PPARG or RXRA.
- Adverse events from prior therapy that have not returned to baseline or stabilized at Grade 1 (except alopecia, hearing loss, vitiligo...
- Prior major surgery (excluding placement of vascular access) within 4 weeks before study drug administration.
- Prior radiation therapy with an inadequate washout between the last dose and the start of study drug, defined as follows: 1) at least 2 weeks for...
See the full eligibility criteria
Who can join
- Part A/B
- Able to understand and willing to sign an informed consent.
- Age ≥ 18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.
- An archival, paraffin-embedded, formalin-fixed, tumor sample (see Laboratory Manual for details) that in Part A is no more than 30 months old at the time of screening or in Part B is no more than 30 months old at time...
- Part A: Histologically or cytologically diagnosed, locally advanced (unresectable) or metastatic solid malignancies that have progressed after all available standard therapy for the specific tumor type, or for which no...
- Treated with ≤ 4 prior therapies for advanced or metastatic disease Patients in Part B must have progressed after all available standard therapy, been unable to tolerate standard therapy, or be considered inappropriate...
- Part A: Patients with or without measurable disease (as defined by RECIST version 1.1) will be eligible for enrollment. Part B: Patients must have measurable disease per RECIST version 1.1 with ≥ 1 site of measurable...
What rules you out
- Female patients who are pregnant (confirmed with a positive pregnancy test) or breastfeeding.
- Prior anticancer chemotherapy or small molecule targeted therapy, either investigational or commercially approved and available, within 2 weeks or 5 half-lives (whichever is shorter) prior to the start of study drug...
- Prior therapy directly inhibiting PPARG or RXRA.
- Adverse events from prior therapy that have not returned to baseline or stabilized at Grade 1 (except alopecia, hearing loss, vitiligo, endocrinopathy managed with replacement therapy, and Grade ≤ 2 neuropathy) prior to...
- Prior major surgery (excluding placement of vascular access) within 4 weeks before study drug administration.
- Prior radiation therapy with an inadequate washout between the last dose and the start of study drug, defined as follows: 1) at least 2 weeks for palliative radiation to the extremities for osseous bone metastases is...
- History of another malignancy in the previous 2 years, unless cured by surgery alone and continuously disease free. Exceptions include appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma...
- QT interval corrected using Fridericia's Formula (QTcF) \>470 msec in screening, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age in first degree...
- Known active diagnosis of lipodystrophy/lipoatrophy, or an ongoing need to receive medications known to cause lipodystrophy/lipoatrophy.
- Any active uncontrolled systemic bacterial, viral, or fungal infection requiring treatment.
- Known history of HIV seropositivity. Those who have no detectable viral load on highly active antiretroviral therapy (HAART) are permitted.
- Patients with chronic hepatitis B virus (HBV) infection. Patients are permitted with either universal prophylaxis or a pre-emptive treatment approach consistent with regional or national guidelines for patients who...
- Active hepatitis C virus (HCV) infection. Those who have completed curative therapy for HCV and have no detectable viral load are permitted.
- Prior diagnosis of chronic or recurrent (\> 1 episode) pancreatitis at any time or a diagnosis of acute pancreatitis within the 6 months prior to screening.
- Significant impairment of lung function indicated by resting oxygen saturations below 92% on room air or requiring chronic use of ambulatory supplemental oxygen.
- Uncontrolled or symptomatic central nervous system (CNS) metastases, leptomeningeal disease, or carcinomatous meningitis. Asymptomatic brain metastasis is allowed if they have been stable after appropriate radiotherapy...
- Need for treatment with high doses of oral or intravenous steroids (\> 10 mg/day prednisone or equivalent). Physiologic doses of corticosteroids for treatment of endocrinopathies may be continued if the patient is on a...
- Need or anticipated need for treatment with a prohibited therapy during the treatment phase of this study.
- Concurrent participation in any other investigational therapeutic study.
- History of any of the following cardiovascular diseases: o Recent history (within the 6 months prior to screening) of serious uncontrolled cardiac arrhythmia (including atrial fibrillation without adequate rate control)...
- Congestive heart failure (Class III or IV) as defined by the New York Heart Association functional classification system
- Recent history (within the past 6 months) of symptomatic pericarditis
- Thromboembolic events and/or bleeding disorders ≤ 28 days (eg, deep vein thrombosis or pulmonary embolism) prior to the first dose of study drug.
- Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, which, in the Investigator's opinion, makes it undesirable for the patient to participate in...
- Patients with type 1 diabetes mellitus, or type 2 diabetes mellitus that is not adequately controlled with diet, exercise, or oral hypoglycemic agents and/or injectable agents other than insulin (as defined by HbA1c and...
- Known hypersensitivity to FX-909 or any of its excipients.
- Patients with gastrointestinal disorders that may interfere with the ability to swallow tablets or absorb study medication.
- Patient is or has an immediate family member (eg, spouse, parent/legal guardian, sibling, or child) who is a member of the study site or Sponsor staff directly involved with this study, unless prospective Institutional...
- Patients with any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient...
- Any condition that, in the opinion of the Investigator, would interfere with evaluation of the investigational product or interpretation of the patient's safety or study results. Part 1A1 Inclusion Criteria: 1\. Able to...
- Received at least 2 doses of an approved anti-PD-1/L1 mAb.
- Documented disease progression after anti-PD-1/L1 treatment (consistent with the principles of RECIST v1.1). The initial evidence of disease progression is to be confirmed by a second assessment no less than 4 weeks...
- Progressive disease has been documented within 12 weeks from the last dose of anti-PD-1/L1 mAb.
- Progressive disease is determined consistent with the principles of RECIST v1.1.
- This determination is made by the investigator. Once disease progression is confirmed, the initial date of disease progression documentation will be considered the date of disease progression. 7\. Measurable disease per...
- Participants on ART must have a CD4+ T-cell count ≥350 cells/mm3 at the time of screening
- Participants on ART must have achieved and maintained virologic suppression, defined as confirmed HIV RNA level below 50 or the LLOQ (below the limit of detection) using the locally available assay at the time of...
- It is advised that participants must not have had any AIDS-defining opportunistic infections within the past 12 months
- Participants on ART must have been on a stable regimen, without changes in drugs or dose modification, for at least 4 weeks before study entry (Day 1) and agree to continue ART throughout the study.
- Participants with HIV should continue ongoing management by their health care provider(s), including monitoring of HIV viral load, CD4+ T-cell count, and appropriate supportive care measures. 13\. Participants who are...
- Known history of HBV infection
- As mandated by local guidelines 14\. Participants with a history of HCV infection are eligible if HCV viral load is undetectable at screening. Note: Participants must have completed curative antiviral therapy at least 4...
- Hepatitis C screening tests are not required unless: 3\. Known history of HCV infection 4. As mandated by local guidelines 15. Adequate organ function as defined in Table 20. Part 1A1 Exclusion Criteria:
- HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
- Participants with type 1 diabetes mellitus, or type 2 diabetes mellitus that is not adequately controlled with diet, exercise, or oral hypoglycemic agents and/or injectable agents other than insulin (as defined by HbA1c...
- Participants with gastrointestinal disorders that may interfere with the ability to swallow tablets or absorb study medication.
- Thromboembolic events and/or bleeding disorders ≤28 days (eg, deep vein thrombosis or pulmonary embolism) prior to the first dose of study drug. Prior/Concomitant Therapy
- Prior therapy inhibiting PPARG or RXRA.
- Received any prior immunotherapy and was discontinued from that treatment due to a Grade 3 or higher irAE (except endocrine disorders that can be treated with replacement therapy) or was discontinued from that treatment...
- Received prior systemic anticancer therapy within 2 weeks or 5 half-lives (whichever is shorter) before the start of study drug administration. When the most recent therapy was a biological therapy (including...
- Note: If participant underwent major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
- Received prior radiotherapy within 2 weeks of the start of study intervention, or has radiation-related toxicities, requiring corticosteroids.
- Note: Two weeks or fewer of palliative radiotherapy for non-CNS disease is permitted. The last radiotherapy treatment must have been performed at least 7 days before the first dose of study intervention.
- Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed. Prior/Concurrent Clinical Study Experience
- Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration. Diagnostic Assessments
- Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in doses exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first...
- Prior diagnosis of chronic or recurrent (\> 1 episode) pancreatitis at any time or a diagnosis of acute pancreatitis within the 6 months prior to screening,
- Significant impairment of lung function indicated by resting oxygen saturations below 92% or requiring chronic use of ambulatory supplemental oxygen.
- Known additional malignancy that is progressing or has required active treatment within the past 2 years.
- Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ, excluding carcinoma in situ of the bladder, that have undergone potentially curative therapy are not...
- Known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable (ie, without evidence of progression) for at...
- Active autoimmune disease that has required systemic treatment in past 2 years except replacement therapy (eg, thyroxine or physiologic corticosteroid).
- History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
- Any active bacterial, viral, or fungal infection requiring systemic therapy.
- History or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the participant's ability to cooperate with the...
- Severe hypersensitivity (≥Grade 3) to FX-909 and pembrolizumab and/or any of its excipients. Other Exclusions
- History of stem cell/solid organ transplant.
- Participants who have not adequately recovered from major surgery or have ongoing surgical complications.
- Need or anticipated need for treatment with a prohibited therapy described in Section 21.11.2 during the treatment phase of this study
- If female, is pregnant, breastfeeding, or expecting to conceive, or if male, expect to father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose...
- Participant is or has an immediate family member who is a member of the study site or Sponsor staff directly involved with this study, unless prospective IRB or EC approval is given allowing exception to this criterion.
- Participants with any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
- Any condition that, in the opinion of the Investigator, would interfere with evaluation of the investigational product or interpretation of the participant's safety or study results.
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, United States
- New Haven, Connecticut, United States
- Miami, Florida, United States
- Chicago, Illinois, United States
- Boston, Massachusetts, United States
- New York, New York, United States
- Chapel Hill, North Carolina, United States
- Cleveland, Ohio, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Francisco, California, United States; New Haven, Connecticut, United States; Miami, Florida, United States; Chicago, Illinois, United States; Boston, Massachusetts, United States; New York, New York, United States and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.