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A Phase I, Open-label, Dose-escalation Study of the Safety and Pharmacokinetics of IMP4297 in Patients with Advanced Solid Tumors
IMPACT Therapeutics, Inc
This clinical trial aims to establish the safety and tolerability profile of the drug IMP4297, to determine the maximum tolerated dose (MTD) of IMP4297, and to evaluate the dose limiting toxicities (DLT) of IMP4297 in study participants with advanced solid malignancy that has progressed on, or failed to respond to, at least one prior systemic therapy. The secondary purposes of this trial are to assess the distribution of IMP4297 at various time points (pharmacokinetics) and to also obtain preliminary information on the antitumour activity of IMP4297.
Who is it for?
You may be eligible to join this study if you are aged 18 years or above and have histologically or cytologically documented, incurable, advanced solid malignancy that has progressed on, or failed to respond to, at least one prior systemic therapy. Patients with breast cancer, ovarian cancer and prostate cancer are preferred. Study details Participants in this trial will initially receive a single dose of the drug IMP4297 to allow an assessment of safety, tolerability and pharmacokinetics (PK). The drug is administered orally in a tablet form. If tolerated, participants will then proceed one week later to receive a daily dose of IMP4297 for 3 weeks. This treatment cycle will then continue until unacceptable toxicity is indicated, the disease progresses, or the study participant withdraws his/her consent; or the study participant meets any other criteria for withdrawal. Up to 6 dose levels are planned to investigate the maximum tolerated dose (MTD) of IMP4297. This trial employs a stepwise dose escalation scheme which allows the safety and tolerability of each dose level to be evaluated before study participants are exposed to a higher dose level. Participants will be required to give blood samples and undergo regular clinical assessments in order to evaluate treatment safety and tolerability.