A Study of FX-909 in Patients With Advanced Solid Malignancies, Including Advanced Urothelial Carcinoma

ConditionsAdvanced Urothelial Carcinoma Oral Drug Administration Open Label

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18+

SponsorFlare Therapeutics Inc.

About this trial

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. Participants will also be asked to return for multiple site visits for various blood tests and to collect blood and tumor samples as well as have regular CT/MRI scans.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 of pre-screening. If an archival tumor sample is not available or is older than 30 months, then the patient must consent to provide a fresh biopsy during screening.

Disqualifiers

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 administration. When the most recent therapy was a biological therapy (including antibody-drug conjugates), an immune-checkpoint inhibitor (eg, anti-PD(L)1 or anti-CTLA4), or immune agonist, patients should wait 4 weeks before starting therapy with FX-909. (See Exclusion Criterion 6 for required radiotherapy windows.)

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 study drug administration.

Trial design

Design model

Sequential

Treatments tested in this trial

FX-909
Drug
FX-909 is an orally available new molecular entity that inhibits basal- and ligand-activated transcription by PPARG.
Pembrolizumab (KEYTRUDA ®)
Drug
Pembrolizumab is an immunotherapy checkpoint inhibitor.
KEYTRUDA ®( Pembrolizumab)
Drug
Keytruda is an immunotherapy checkpoint inhibitor.

Treatment groups

120 Participants

are divided into 3 treatment groups

Group A: Dose EscalationExperimental treatment 1 intervention

Group B: Expansion ExpansionExperimental treatment 1 intervention

Group C: FX-909 in Combination with PembrolizumabExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

To assess dose-limiting toxicities, the incidence and severity of adverse events and serious adverse events associated with FX-909 (Safety and Tolerability)

Incidence of dose-limiting toxicities (DLTs); Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)

Time frame