BEBT-209 / BeBetter Med - LARVOL DELTA

A Study of BEBT-209 Plus Chemotherapy in Patients With Locally Advanced or Metastatic Triple-Negative Breast Cancer (clinicaltrials.gov) - P2/3 | N=446 | Recruiting | Sponsor: BeBetter Med Inc | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • Hormone Receptor Negative Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • ER • HER-2 • PGR

GBMT-209B-P01: A Study of BEBT-209 in Combination With Chemotherapy for the Treatment of Advanced Triple-Negative Breast Cancer (clinicaltrials.gov) - P2 | N=65 | Completed | Sponsor: BeBetter Med Inc | N=120 ➔ 65 | Trial completion date: Dec 2026 ➔ May 2026 | Recruiting ➔ Completed

Enrollment change • Trial completion • Trial completion date • Breast Cancer • Hormone Receptor Negative Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • HER-2 • PGR

Phase I Study of BEBT-209 in Women With Advanced Breast Cancer (clinicaltrials.gov) - P1 | N=100 | Completed | Sponsor: BeBetter Med Inc | Active, not recruiting ➔ Completed

Trial completion • Breast Cancer • HER2 Breast Cancer • Oncology • Solid Tumor • HER-2

A Study of BEBT-209 Plus Chemotherapy in Patients With Locally Advanced or Metastatic Triple-Negative Breast Cancer (clinicaltrials.gov) - P2/3 | N=446 | Not yet recruiting | Sponsor: BeBetter Med Inc

New P2/3 trial • Breast Cancer • Hormone Receptor Negative Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • ER • HER-2 • PGR

BEBT-209, a primary CDK4 selective inhibitor, for the treatment of HR+/HER2- advanced breast cancer (BECTOP1): a phase 1, multicentre, open-label study. (PubMed, Breast) - "BEBT-209 was a primary CDK4 selective inhibitor and showed an acceptable safety profile and dose-dependent plasma exposure. The results highlight the potential of combination treatments as compelling options, particularly in combination with fulvestrant."

Journal • P1 data • Breast Cancer • Hematological Disorders • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Neutropenia • Oncology • Solid Tumor • HER-2

Efficacy and safety of BEBT-209, a primary CDK4 inhibitor, in combination with gemcitabine and carboplatin for metastatic triple-negative breast cancer. (ASCO 2025) - P2 | "Antibody-drug conjugates (ADCs), such as sacituzumab govitecan (SG), demonstrate limited efficacy, achieving a 31% objective response rate (ORR) and mPFS of 4.8 months in the ASCENT trial. BEBT-209 in combination with GC demonstrates promising efficacy and a favorable safety profile in mTNBC patients with early relapse or prior systemic therapy. The observed improvements in ORR and PFS compared to current standards of care highlight the potential of BEBT-209 as a breakthrough therapy for this aggressive disease. A global Phase III trial is planned to further validate these findings."

Clinical • Combination therapy • Metastases • Anemia • Breast Cancer • Leukopenia • Neutropenia • Oncology • Solid Tumor • Thrombocytopenia • Triple Negative Breast Cancer • CDK6

Study of BEBT-209 in Combination With Fulvestrant Versus Placebo in Combination With Fulvestrant in Patients With HR+/HER2- Locally Advanced or Metastatic Breast Cancer Who Have Progressed After Prior Endocrine Therapy (clinicaltrials.gov) - P3 | N=330 | Recruiting | Sponsor: BeBetter Med Inc

New P3 trial • Breast Cancer • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor

A Study of BEBT-209 in Combination With Chemotherapy for the Treatment of Advanced Triple-Negative Breast Cancer (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: BeBetter Med Inc

New P2 trial • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

Phase I Study of BEBT-209 in Women With Advanced Breast Cancer (clinicaltrials.gov) - P1 | N=106 | Active, not recruiting | Sponsor: BeBetter Med Inc

Metastases • New P1 trial • Breast Cancer • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • HER-2