A Phase 1b Open-Label Multicenter Study of OP-1250 (Palazestrant) in Combination With the CDK4/6 Inhibitor Ribociclib, With the PI3K Inhibitor Alpelisib, With the mTOR Inhibitor Everolimus, or With CDK4 Inhibitor Atirmociclib in Adult Subjects With Advanced and/or Metastatic ER Positive, HER2 Negative Breast Cancer

Summary

This is a Phase 1b open-label, 2-part study in 3 treatment groups. The 3 treatment groups are as follows: Treatment Group 1: Palazestrant (OP-1250) in combination with ribociclib (KISQALI®, Novartis Pharmaceuticals Corporation). Treatment Group 2: Palazestrant (OP-1250) in combination with alpelisib (PIQRAY®, Novartis Pharmaceuticals Corporation). Treatment Group 3: Palazestrant (OP-1250) in combination with everolimus. Treatment Group 4: Palazestrant (OP-1250) in combination with atirmociclib.

Description

Eligibility

Age range

18+ years

Sex

All

Healthy volunteers

No

Interventions

• Drug
  Palazestrant

  Complete estrogen receptor antagonist (CERAN)

• Drug
  Ribociclib

  All subjects in Treatment Group 1 will receive palazestrant in combination with ribociclib.

• Drug
  Alpelisib

  All subjects in Treatment Group 2 will receive palazestrant in combination with alpelisib.

• Drug
  Everolimus

  All subjects in Treatment Group 3 will receive palazestrant in combination with everolimus.

• Drug
  Atirmociclib

  All subjects in Treatment Group 4 will receive palazestrant in combination with atirmociclib.

Locations (16)