Trial Title:
A Study Investigating BGB-26808 Alone or in Combination With Tislelizumab in Participants With Advanced Solid Tumors
NCT ID:
NCT05981703
Condition:
Advanced Solid Tumor
Solid Tumor
Conditions: Official terms:
Neoplasms
Tislelizumab
Conditions: Keywords:
advanced solid tumor
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
BGB-26808
Description:
Planned doses administered orally as a tablet daily.
Arm group label:
Dose Escalation
Arm group label:
Dose Expansion
Intervention type:
Drug
Intervention name:
Tislelizumab
Description:
Planned doses administered by intravenous infusion.
Arm group label:
Dose Escalation
Arm group label:
Dose Expansion
Other name:
BGB-A317
Summary:
This is an open-label, multicenter, and nonrandomized dose escalation and dose expansion
study to evaluate BGB-26808 as monotherapy or in combination with tislelizumab in
participants with advanced solid tumors. The main purpose of this study is to explore the
recommended dosing for BGB-26808.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Able to provide a signed and dated written informed consent prior to any
study-specific procedures, sampling, or data collection.
2. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.
3. Participants with histologically or cytologically confirmed advanced, metastatic,
and unresectable solid tumors that are immune-sensitive who have been previously
treated.
4. ≥ 1 measurable lesion per RECIST v1.1.
5. Able to provide an archived tumor tissue sample.
6. Adequate organ function.
7. Females of childbearing potential must be willing to use a highly effective method
of birth control for the duration of the study, and for ≥ 90 days after the last
dose of BGB-26808 or for ≥ 120 days after the last dose of tislelizumab.
8. Nonsterile males must be willing to use a highly effective method of birth control
for the duration of the study treatment period and for ≥ 90 days after the last dose
of BGB-26808 or for ≥ 120 days after the last dose of tislelizumab.
Exclusion Criteria:
1. Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent
drainage or medical intervention.
2. Clinically significant bleeding from the gastrointestinal tract within 28 days
before the first dose of study treatment(s).
3. Active leptomeningeal disease or uncontrolled, untreated brain metastasis.
4. Active autoimmune diseases or history of autoimmune diseases that may relapse
5. 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).
6. Any condition that required systemic treatment with either corticosteroids (> 10 mg
daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days
before the first dose of study treatment(s).
7. History of interstitial lung disease, noninfectious pneumonitis, or uncontrolled
lung diseases including pulmonary fibrosis, acute lung diseases.
8. Uncontrolled diabetes.
9. Infection (including tuberculosis infection) requiring systemic (oral or
intravenous) antibacterial, antifungal, or antiviral therapy ≤ 14 days before the
first dose of study treatment(s).
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Yale University, Yale Cancer Center
Address:
City:
New Haven
Zip:
06520
Country:
United States
Status:
Recruiting
Facility:
Name:
Sylvester Cancer Center, University of Miami
Address:
City:
Miami
Zip:
33136
Country:
United States
Status:
Recruiting
Facility:
Name:
John Theurer Cancer Center Hackensack University Medical Center
Address:
City:
Hackensack
Zip:
07601
Country:
United States
Status:
Recruiting
Facility:
Name:
Icahn School of Medicine At Mount Sinai
Address:
City:
New York
Zip:
10029
Country:
United States
Status:
Recruiting
Facility:
Name:
Providence Portland Medical Center
Address:
City:
Portland
Zip:
97213
Country:
United States
Status:
Recruiting
Facility:
Name:
The University of Texas Md Anderson Cancer Center
Address:
City:
Houston
Zip:
77030-4009
Country:
United States
Status:
Recruiting
Facility:
Name:
Southside Cancer Care
Address:
City:
Miranda
Zip:
2228
Country:
Australia
Status:
Recruiting
Facility:
Name:
Macquarie University
Address:
City:
North Ryde
Zip:
2109
Country:
Australia
Status:
Recruiting
Facility:
Name:
Icon Cancer Centre Kurralta Park
Address:
City:
Kurralta Park
Zip:
5037
Country:
Australia
Status:
Recruiting
Facility:
Name:
Linear Clinical Research
Address:
City:
Nedlands
Zip:
6009
Country:
Australia
Status:
Recruiting
Facility:
Name:
Harbin Medical University Cancer Hospital
Address:
City:
Harbin
Zip:
150000
Country:
China
Status:
Recruiting
Facility:
Name:
Hubei Cancer Hospital
Address:
City:
Wuhan
Zip:
430079
Country:
China
Status:
Recruiting
Facility:
Name:
The First Hospital of China Medical University Hunnan Branch
Address:
City:
Shenyang
Zip:
110167
Country:
China
Status:
Recruiting
Facility:
Name:
Jining No Peoples Hospital West Branch
Address:
City:
Jining
Zip:
272000
Country:
China
Status:
Recruiting
Facility:
Name:
Shanghai East Hospital Branch Hospital
Address:
City:
Shanghai
Zip:
200123
Country:
China
Status:
Recruiting
Facility:
Name:
Shanghai Pulmonary Hospital
Address:
City:
Shanghai
Zip:
200433
Country:
China
Status:
Recruiting
Facility:
Name:
Taizhou Hospital of Zhejiang Province (East)
Address:
City:
Taizhou
Zip:
317004
Country:
China
Status:
Recruiting
Facility:
Name:
Auckland City Hospital
Address:
City:
Auckland
Zip:
1023
Country:
New Zealand
Status:
Recruiting
Start date:
September 7, 2023
Completion date:
February 2027
Lead sponsor:
Agency:
BeiGene
Agency class:
Industry
Source:
BeiGene
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05981703
