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Trial Title:
Safety, Pharmacokinetics, and Antitumor Activity of BGB-B167 Alone and in Combination With Tislelizumab (BGB-A317) in Participants With Advanced Solid Tumors
NCT ID:
NCT05494762
Condition:
Solid Tumor
Conditions: Official terms:
Neoplasms
Tislelizumab
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Active, not recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
BGB-B167
Description:
Intravenous administration
Arm group label:
Phase 1a: Dose Escalation
Arm group label:
Phase 1b: Dose Expansion
Intervention type:
Drug
Intervention name:
Tislelizumab
Description:
Intravenous administration
Arm group label:
Phase 1a: Dose Escalation
Arm group label:
Phase 1b: Dose Expansion
Other name:
BGB-A317
Summary:
This study will evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary
antitumor activity of BGB-B167 monotherapy and in combination with tislelizumab
(BGB-A317) in participants with select advanced solid tumors.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Age 18 or older
- Participants with histologically or cytologically confirmed unresectable locally
advanced or metastatic solid tumors previously treated with standard systemic
therapy or for whom treatment is not available, not tolerated, or refused, or not
expected to provide significant clinical benefit or be tolerated in the medical
judgement of the investigator
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1
- Adequate organ function as indicated by laboratory values during screening or ≤ 7
days before the first dose of study drug(s)
Exclusion Criteria:
- Active leptomeningeal disease or uncontrolled, untreated brain metastasis
- Active autoimmune diseases or history of autoimmune diseases that may relapse
- 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
- History of severe hypersensitivity reactions to other monoclonal antibody products
or their excipients
- Women who are pregnant or are breastfeeding
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:
City of Hope National Medical Center
Address:
City:
Duarte
Zip:
91010
Country:
United States
Facility:
Name:
Yale University, Yale Cancer Center
Address:
City:
New Haven
Zip:
06520
Country:
United States
Facility:
Name:
Tennessee Oncology, Pllc Nashville
Address:
City:
Nashville
Zip:
37203
Country:
United States
Facility:
Name:
Blacktown Cancer and Haematology Centre
Address:
City:
Blacktown
Zip:
2148
Country:
Australia
Facility:
Name:
Icon Cancer Centre Kurralta Park
Address:
City:
Kurralta Park
Zip:
5037
Country:
Australia
Facility:
Name:
Monash Health
Address:
City:
Clayton
Zip:
3168
Country:
Australia
Facility:
Name:
Peter Maccallum Cancer Centre
Address:
City:
Melbourne
Zip:
3000
Country:
Australia
Facility:
Name:
The Alfred Hospital
Address:
City:
Melbourne
Zip:
3004
Country:
Australia
Start date:
August 25, 2022
Completion date:
January 31, 2025
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/NCT05494762
