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New treatment option for Advanced Malignancies
Official title An Open-Label Study to Evaluate PF-07994525 in Participants With Advanced Cancers
ClinicalTrials.gov ID: NCT07426757
What this study is testing
What is PF-07994525?
PF-07994525 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for advanced malignancies.
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
- This is an open-label, dose escalation and dose expansion study evaluating the safety, tolerability, Pharmacokinetic (PK), Pharmacodynamic (PD), and antitumor activity of PF-07994525 in participants with R/R MM. The study will consist of 2 parts: Part 1 (Dose Escalation) will consist of PF-07994525 dose escalation to assess the safety, tolerability, and preliminary antitumor activity in participants with R/R MM.
- 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
- Participants aged 18 years or older (or the minimum age of consent in accordance with local regulations) at the time of informed consent.
- Prior diagnosis of MM as defined according to IMWG criteria (Rajkumar et al. 2014) Measurable disease based on IMWG criteria as defined by at least 1...
- Serum M-protein \>0.5 g/dL by serum protein electrophoresis (SPEP)
- Urinary M-protein excretion \>200 mg/24 hours by urine protein electrophoresis (UPEP)
- Serum immunoglobulin Free Light Chain (FLC) ≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio (\ 1.65)
You likely can't join if
- Active plasma cell leukemia, Smoldering MM, Waldenströms macroglobulinemia, Amyloidosis, POEMS Syndrome.
- Autologous stem cell transplant within 12 weeks prior to enrollment or active Graft-versus-host disease (GVHD).
- Active or suspected cerebral/meningeal disease related to the underlying malignancy.
- Any active, uncontrolled bacterial, fungal, or viral infection, including (but not limited to) COVID-19, Hepatitis B Virus (HBV), Hepatitis C Virus...
See the full eligibility criteria
- Participants aged 18 years or older (or the minimum age of consent in accordance with local regulations) at the time of informed consent.
- Prior diagnosis of MM as defined according to IMWG criteria (Rajkumar et al. 2014) Measurable disease based on IMWG criteria as defined by at least 1 of the following:
- Serum M-protein \>0.5 g/dL by serum protein electrophoresis (SPEP)
- Urinary M-protein excretion \>200 mg/24 hours by urine protein electrophoresis (UPEP)
- Serum immunoglobulin Free Light Chain (FLC) ≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio (\ 1.65)
- Participants must be refractory to, or intolerant to, all established therapies known to provide clinical benefit in multiple myeloma that are an appropriate therapeutic option, in the judgement of the investigator. A...
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Active plasma cell leukemia, Smoldering MM, Waldenströms macroglobulinemia, Amyloidosis, POEMS Syndrome.
- Autologous stem cell transplant within 12 weeks prior to enrollment or active Graft-versus-host disease (GVHD).
- Active or suspected cerebral/meningeal disease related to the underlying malignancy.
- Any active, uncontrolled bacterial, fungal, or viral infection, including (but not limited to) COVID-19, Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), known HIV or AIDS related illness, unless deemed not clinically...
The study team makes the final eligibility decision.
Where it's taking place
- Coral Gables, Florida, United States
- Coral Springs, Florida, United States
- Deerfield Beach, Florida, United States
- Doral, Florida, United States
- Hollywood, Florida, United States
- Miami, Florida, United States
- North Miami, Florida, United States
- Plantation, Florida, United States
- Atlanta, Georgia, United States
- Nashville, Tennessee, United States
- Calgary, Alberta, Canada
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 Coral Gables, Florida, United States; Coral Springs, Florida, United States; Deerfield Beach, Florida, United States; Doral, Florida, United States; Hollywood, Florida, United States; Miami, Florida, United States and 5 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.