NCT07408089

Study of the Kinesin Oral Molecular Degrader BBI-940 in Subjects With Advanced or Metastatic Breast Cancer

An Open-Label, Multicenter, First-in-Human, Phase 1 Study of BBI-940 in Advanced or Metastatic Breast Cancer: Kinesin Oral Molecular Degrader for Oncology (KOMODO-1)

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: Boundless Bio, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a first-in-human, open-label, Phase 1 study evaluating BBI-940, an investigational kinesin oral molecular degrader, administered as monotherapy or in combination with fulvestrant in adults with advanced or metastatic breast cancer.

Detailed description

The study consists of two parts: Part 1 (dose escalation) and Part 2 (dose expansion). Part 1 is a dose-escalation phase designed to evaluate the safety and tolerability of BBI-940 and to determine the recommended dose for expansion (RDE). Participants may have estrogen receptor-positive, HER2-negative (ER+/HER2-) breast cancer or triple-negative breast cancer of the luminal androgen receptor subtype (TNBC-LAR). Part 2 is a dose-expansion phase designed to further evaluate BBI-940 at the selected RDE in defined participant populations. Part 2A evaluates BBI-940 in combination with fulvestrant, including multiple dose cohorts to evaluate the safety of the combination regimen and to determine the combination RDE in participants with ER+/HER2- breast cancer without an ESR1 mutation. Part 2B evaluates BBI-940 monotherapy at the RDE in participants with ER+/HER2- breast cancer with FGFR1 amplification. Part 2C evaluates BBI-940 monotherapy at the RDE in participants with TNBC-LAR. Across all parts of the study, treatment is administered in repeated 28-day cycles, and participants undergo protocol-specified safety assessments.

Conditions

• Breast Cancer
• Metastatic Breast Cancer
• Advanced Breast Cancer

Interventions

Type	Name	Description
DRUG	BBI-940	Oral small molecule degrader targeting Kinesin.
DRUG	Fulvestrant	Selective estrogen receptor degrader administered intramuscularly.

Timeline

• Start date: 2026-02-25
• Primary completion: 2029-02-28
• Completion: 2029-05-31
• First posted: 2026-02-12
• Last updated: 2026-04-13

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study