Informations générales (source: ClinicalTrials.gov)
A Phase 1a/1b Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BGB-A3055, Alone and in Combination With Tislelizumab in Patients With Selected Advanced or Metastatic Solid Tumors
Interventional
Phase 1
BeiGene (Voir sur ClinicalTrials)
août 2023
février 2025
18 octobre 2024
This study aims to test the safety, tolerability, and preliminary anti-tumor activity of
BGB-A3055, either alone or in combination with Tislelizumab in participants with advanced
or metastatic solid tumors.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | 04/09/2024 13:49:38 | 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 - 33076 - Bordeaux - France | Contact (sur clinicalTrials) | ||||
| Ico Site Rene Gauducheau - 44805 - SaintHerblain - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
1. Age≥18 years on the day of signing the informed consent form (ICF) (or the legal age
of consent in the jurisdiction in which the study is taking place, whichever is
older).
2. All participants are also required to demonstrate an ECOG Performance Status score
of≤1 and have adequate organ function.
3. Participants with histologically confirmed advanced or metastatic solid tumors
associated with high CCR8 and who have previously received available standard
systemic therapy or for whom treatment is not available or not tolerated and could
not receive any prior therapy targeting CCR8.
4. >=1 Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST)
v1.1
5. Participants should be able to provide the archival formalin-fixed paraffin-embedded
(FFPE) tumor tissues (as block or unstained slides) or fresh biopsy if there is no
archival tissue at baseline. For selected cohorts, participants should be willing to
provide post-treatment fresh biopsy at specified timepoints.
1. Age≥18 years on the day of signing the informed consent form (ICF) (or the legal age
of consent in the jurisdiction in which the study is taking place, whichever is
older).
2. All participants are also required to demonstrate an ECOG Performance Status score
of≤1 and have adequate organ function.
3. Participants with histologically confirmed advanced or metastatic solid tumors
associated with high CCR8 and who have previously received available standard
systemic therapy or for whom treatment is not available or not tolerated and could
not receive any prior therapy targeting CCR8.
4. >=1 Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST)
v1.1
5. Participants should be able to provide the archival formalin-fixed paraffin-embedded
(FFPE) tumor tissues (as block or unstained slides) or fresh biopsy if there is no
archival tissue at baseline. For selected cohorts, participants should be willing to
provide post-treatment fresh biopsy at specified timepoints.
1. Active leptomeningeal disease or uncontrolled, untreated brain metastasis.
2. Active autoimmune diseases or history of autoimmune diseases that may relapse
3. Any malignancy ≤ 3 years before the first dose of study drug(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).
4. Untreated chronic hepatitis B or chronic HBV carriers with HBV DNA ≥ 500 IU/mL (or ≥
2500 copies/mL) at screening. Participants with active hepatitis C, and participants
with HIV infection.
Note: Inactive hepatitis B surface antigen (HBsAg) carriers, treated and stable
hepatitis B can be enrolled. Participants with a negative HCV antibody test result
at screening or a positive HCV antibody test result followed by a negative HCV RNA
test result at screening are eligible to participate. Participants with treated HIV
infection may be included if certain criteria are met.
5. History of interstitial lung disease, noninfectious pneumonitis, or uncontrolled
lung diseases including pulmonary fibrosis, or acute lung diseases .
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.