Clinical trials are an important way to improve treatment for people with cancer. While most are continuing during the COVID-19 pandemic, the period of time that clinical trials are available and recruiting may change quickly. If you would like to get involved in a clinical trial, speak to your treatment team or the health service where the clinical trial is being undertaken, to confirm it is open and appropriate for you. For cancer information and support, call Cancer Council's experienced cancer nurses on 13 11 20 Monday to Friday from 9am-5pm.

KAT6 : A Phase 1 Dose Escalation and Expansion Study to Evaluate Safety, Tolerability, Pharmacokinetic, Pharmacodynamic, and Anti-tumor Activity of PF-07248144 in Participants With Advanced or Metastatic 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,Lung,Urinary systemBreast,Non-Small Cell Lung Cancer,Prostate

Trial Overview Read MoreRead more

This phase I study is trying to understand how safe, tolerable and effective a new targeted therapy (PF-07248144) is alone, or combined with either hormone therapy (fulvestrant) or hormone therapy (letrozole) and another targeted therapy (palbociclib), in people with breast cancer, prostate cancer or non-small cell lung cancer.
 

This trial is treating patients with Non-small cell lung cancer, castration-resistant prostate cancer, and ER+, HER2- breast cancer.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You have been diagnosed with cancer, but have not received any treatment.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • Your cancer has not spread to other parts of the body.
  • Your cancer has spread to other parts of the body.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.

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 1 Dose Escalation and Expansion Study to Evaluate Safety, Tolerability, Pharmacokinetic, Pharmacodynamic, and Anti-tumor Activity of PF-07248144 in Participants With Advanced or Metastatic Solid Tumors.

Commercial Sponsor

Pfizer

Summary

This study has two parts, Part 1 (dose escalation) and Part 2 (dose expansion). Part 1 is divided into Parts 1A, 1B, and 1C and Part 2 is divided into Parts 2A and 2B. In Part 1A, single escalating doses of PF-07248144 alone will be administered to determine the maximum tolerable dose (MTD) and select the recommended dose for expansion (RP2D). In Part 1B and 1C, PF-07248144 will be administered in combination with either fulvestrant or letrozole + palbociclib. After the determination of the monotherapy expansion RP2D in Part 1A, PF-07248144 will be evaluated in a dose expansion cohort as a monotherapy in Part 2A. After determination of the combination RP2D from Part 1B and Part 1C, PF-07248144 in combination with an either fulvestrant (Part 1B) or letrozole + palbociclib (Part 1C) may be evaluated in Part 2B. The specific combination partners that will be carried forward to Part 2B will be contingent upon preclinical evidence, clinical safety and potential efficacy as well as pharmacokinetic and Ppharmacodynamic data.

Recruiting Hospitals Read MoreRead more

PCCTU (Parkville Cancer Clinical Trials Unit) *
Parkville
Heather Rootes
PCCTU.Breast@petermac.org

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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