IMP4297 : A Phase I, Open-label, Dose-escalation Study of the Safety and Pharmacokinetics of IMP4297 in Patients with Advanced Solid Tumors

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

OnePhase One

18+Age Over 18

Advanced CancersCancer LocationMulti-Cancer
Trial

Systemic therapy | Breast, Female reproductive organs, Urinary systemProstate,Ovary,Breast

Trial Overview Read MoreRead more

This phase I trial is evaluating a new drug (IMP4297) for the treatment of advanced cancers (excluding blood cancer).
 

This trial is treating multiple types of cancer including Breast, Ovarian, Prostate.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You have had treatment, but your cancer has come back.
  • Your cancer has spread to other parts of the body.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You are able to swallow medication by mouth.

You may be excluded from this trial if:

  • You have had certain treatments, surgical procedures or drugs.
  • You have a certain disease or psychological condition.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific Title

A Phase I, Open-label, Dose-escalation Study of the Safety and Pharmacokinetics of IMP4297 in Patients with Advanced Solid Tumors

Commercial Sponsor

IMPACT Therapeutics, Inc

Summary

Study details: 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.

Recruiting Hospitals Read MoreRead more

Epworth Hospital
Richmond
Ms Felicity Osmond
felicity.osmond@epworth.org.au
03 9936 8055

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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