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
BeiGene (Voir sur ClinicalTrials)
décembre 2023
juin 2028
12 juillet 2025
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 dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | Contact (sur clinicalTrials) | ||||
| CLCC INSTITUT GUSTAVE ROUSSY | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre de Lutte Contre Le Cancer Institut Bergonie - 33000 - Bordeaux - France | Contact (sur clinicalTrials) | ||||
| Centre Eugene Marquis - 35043 - Rennes - France | Contact (sur clinicalTrials) | ||||
| Centre Francois Baclesse - 14000 - Caen - France | Contact (sur clinicalTrials) | ||||
| Centre Oscar Lambret - 59000 - Lille - France | Contact (sur clinicalTrials) | ||||
| Institut de Cancerologie de Louest - 44800 - St Herblain - France | Contact (sur clinicalTrials) | ||||
| Institut Paoli Calmettes - 13009 - Marseille - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- Phase 1a (Dose Escalation) and 1b (Dose Expansion): 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.
- Phase 1a: Received prior therapy for their condition (if available) and should be
refractory to, or intolerant of standard-of-care therapies. In regions where
approved and available, participants with HR+ breast cancer must have received at
least 2 prior lines of treatment including endocrine therapy and a CDK4/6 inhibitor.
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 1b: Selected tumor cohorts will include HR+/HER2- breast cancer and additional
tumor types.
- Phase 1b: Participants with HR+/HER2- breast cancer enrolled in regions where CDK4/6
inhibitors are approved and available must have received at least one line of
therapy for advanced disease including endocrine therapy and a CDK4/6 inhibitor.
Participants can have received up to 2 lines of prior cytotoxic chemotherapy 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.
- Phase 1a (Dose Escalation) and 1b (Dose Expansion): 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.
- Phase 1a: Received prior therapy for their condition (if available) and should be
refractory to, or intolerant of standard-of-care therapies. In regions where
approved and available, participants with HR+ breast cancer must have received at
least 2 prior lines of treatment including endocrine therapy and a CDK4/6 inhibitor.
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 1b: Selected tumor cohorts will include HR+/HER2- breast cancer and additional
tumor types.
- Phase 1b: Participants with HR+/HER2- breast cancer enrolled in regions where CDK4/6
inhibitors are approved and available must have received at least one line of
therapy for advanced disease including endocrine therapy and a CDK4/6 inhibitor.
Participants can have received up to 2 lines of prior cytotoxic chemotherapy 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.
- Prior therapy selectively targeting CDK4 (prior CDK4/6 inhibitor therapy is
permitted and required in local regions where it is approved and available).
- 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.