Informations générales (source: ClinicalTrials.gov)
A Phase 1a/1b Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of the CDK4 Inhibitor BGB-43395, Alone or as Part of Combination Therapies in Patients With Metastatic HR+/HER2- Breast Cancer and Other Advanced Solid Tumors
Interventional
Phase 1
BeOne Medicines (Voir sur ClinicalTrials)
décembre 2023
novembre 2028
28 juillet 2026
This is a dose escalation and dose expansion study to compare how well BGB-43395, a
selective cyclin-dependent kinase 4 (CDK4) inhibitor, works as monotherapy or in
combination with fulvestrant, letrozole, or elacestrant in participants with hormone
receptor positive (HR+) and human epidermal growth factor 2 negative (HER2-) breast
cancer (BC) and other advanced solid tumors. The main purpose of this study is to explore
the recommended dosing for BGB-43395.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Santiago PONCE-AIX | 10/07/2026 20:40:05 | Contacter | ||
Critères
Tous
- Phase 1a (Dose Escalation): Participants with histologically or cytologically
confirmed advanced, metastatic, or unresectable solid tumors associated with
dependency on CDK4, including HR+ breast cancer, ovarian cancer, endometrial cancer,
non-small cell lung cancer, and others. For combination with elacestrant,
participants must have received at least 1 prior line of treatment for
advanced/metastatic disease including prior endocrine therapy and CDK4/6 inhibitor
in either the adjuvant or advanced/metastatic setting.
- Phase 1a Safety Expansion: For combination with fulvestrant in regions where
approved and available, participants with HR+ breast cancer must have received at
least 1 prior line of treatment including endocrine therapy and a CDK4/6 inhibitor.
For combination with letrozole, participants must be CDK4/6 inhibitor treatment
naïve and have not received any previous systemic treatment for advanced disease.
- Phase 1b: Participants with HR+/HER2- breast cancer.
- Phase 1b: For combination with fulvestrant, participants with HR+/HER2- breast
cancer enrolled in regions where CDK4/6 inhibitors are approved and available must
have received 1-2 lines of therapy for advanced/metastatic disease including
endocrine therapy and a CDK4/6 inhibitor. Participants can have received up to 2
lines of prior cytotoxic chemotherapy for advanced disease. Prior cytotoxic
treatment is prohibited. For combination cohorts with letrozole, participants must
be CDK4/6 inhibitor treatment naïve and have not received any previous systemic
treatment for advanced disease.
- Stable Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.
- Female participants with metastatic HR+/HER2- breast cancer must be postmenopausal
or receiving ovarian function suppression treatment.
- Adequate organ function without symptomatic visceral disease.
Exclusion Criteria:
- Known leptomeningeal disease or uncontrolled, untreated brain metastases.
- Any malignancy ≤ 3 years before the first dose of study treatment(s) except for the
specific cancer under investigation in this study and any locally recurring cancer
that has been treated with curative intent (eg, resected basal or squamous cell skin
cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast).
- Uncontrolled diabetes.
- Infection requiring systemic antibacterial, antifungal, or antiviral therapy ≤ 28
days before the first dose of study drug(s), or symptomatic COVID-19 infection.
- Participants with untreated chronic hepatitis B or chronic hepatitis B virus (HBV)
carriers with HBV DNA ≥ 500 IU/mL (or ≥ 2500 copies/mL) at screening.
- Participants with active hepatitis C infection.
- Prior allogeneic stem cell transplantation, or organ transplantation.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.