STX-478-PIKALO-1

A First-in-Human Study of Treatment With STX-478 Alone, a Mutant Selective PI3Kα Inhibitor, and in Combination With Other Antineoplastic Agents in Participants
with advanced solid tumors

  • NKI code: M24GMS
  • Company Code: STX-478-101
  • Code clinicaltrials.gov: NCT05768139

Principal investigator

Dr. van Dongen

Medication

STX-478 (PI3Ka inhibitor) combined with fulvestrant

Summary

In this study, we aim to find a safe and acceptable dose of the new drug STX-478 alone and in combination with fulvestrant. STX-478 alone is tested in different strengths in patients with advanced solid tumors. STX-478 in combination with fulvestrant is supported in patients with advanced or metastatic breast cancer.

We also want to know how the body copes with STX-478 and the combination therapy with fulvestrant. We are investigating the effects of STX-478 alone and in combination with fulvestrant on humans in this study.
This study will also look at the safety of the new drug STX-478 in combination with fulvestrant and either ribociclib or palbociclib in people with advanced or metastatic breast cancer and how the body deals with that treatment.

We are investigating what effects STX-478 in combination with fulvestrant and either ribociclib or palbociclib has on humans in this study. This study will also monitor your quality of life while taking the combination of fulvestrant and either ribociclib or palbociclib using questionnaires that you complete.

Read more on clinicaltrials.gov.

Notes

  • COHORT B – ER-positive breast cancer – open
  • COHORT C-D – ER-positive breast cancer – open
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