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
mars 2027
05 avril 2025
This study aims to evaluate how safe and well-tolerated the treatment is, how the body
processes it, how it works on the tumors, and whether it shows early signs of fighting
cancer in people with certain advanced or metastatic solid tumors.
Key details of the study include:
- The study is expected to last about 36 months.
- Participants will receive treatment until they either no longer benefit from the
treatment, experience side effects that are too severe, or choose to stop
participating.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | 10/04/2025 13:12:08 | 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 within 3 days before the first dose of study drug(s) and have adequate organ
function.
3. Participants with histologically confirmed advanced or metastatic solid tumors
associated with high CCR8 and who have previously received adequate available
standard systemic therapy or for whom treatment is not available or not tolerated
and who have not received 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 archival tumor tissue samples (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.
6. Females of childbearing potential and nonsterile males must be willing to use a
highly effective method of birth control for the duration of the study, and for ≥
120 days after the last dose of BGB-A3055 or tislelizumab (whichever is later), or
up to 9 months after the last dose of chemotherapy, whichever is later. Females of
childbearing potential must also have a negative urine or serum pregnancy test
result ≤ 7 days before the first dose of study drug(s).
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 within 3 days before the first dose of study drug(s) and have adequate organ
function.
3. Participants with histologically confirmed advanced or metastatic solid tumors
associated with high CCR8 and who have previously received adequate available
standard systemic therapy or for whom treatment is not available or not tolerated
and who have not received 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 archival tumor tissue samples (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.
6. Females of childbearing potential and nonsterile males must be willing to use a
highly effective method of birth control for the duration of the study, and for ≥
120 days after the last dose of BGB-A3055 or tislelizumab (whichever is later), or
up to 9 months after the last dose of chemotherapy, whichever is later. Females of
childbearing potential must also have a negative urine or serum pregnancy test
result ≤ 7 days before the first dose of study drug(s).
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. Participants with hepatitis B infection with HBV DNA ≥ 500 IU/mL (or ≥ 2500
copies/mL). Participants with active hepatitis C, and participants with HIV
infection.
Note: Participants with chronic hepatitis B infection or resolved hepatitis B
infection (HBV DNA < 500 IU/mL or < 2500 copies/mL) and considered stable are
eligible. 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.
6. Grade 3 immune-mediated adverse events on prior immune-oncology agent.
7. Cardiovascular risk factors, including but not limited to pulmonary embolism ≤ 28
days or history of acute myocardial infarction or heart failure ≤ 6 months before
the first dose of study drug(s).
8. Uncontrolled diabetes.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.