Trial Title:
A Study of BGB-A3055, Alone and in Combination With Tislelizumab in Participants With Selected Advanced or Metastatic Solid Tumors
NCT ID:
NCT05935098
Condition:
Advanced Solid Tumor
Metastatic Solid Tumor
Solid Tumor
Conditions: Official terms:
Neoplasms
Tislelizumab
Conditions: Keywords:
BGB-A3055
Tislelizumab
Advanced solid tumors
Safety monitoring
Monoclonal antibody
Preliminary antitumor activity
Metastatic cancer
Metastatic Solid Tumor
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
BGB-A3055
Description:
Administered intravenously
Arm group label:
Phase 1a Part A: Dose Escalation (BGB-A3055 Monotherapy)
Arm group label:
Phase 1a Part B: Dose Escalation (BGB-A3055 + tislelizumab)
Arm group label:
Phase 1b (Dose Expansion):
Intervention type:
Drug
Intervention name:
Tislelizumab
Description:
Administered intravenously
Arm group label:
Phase 1a Part B: Dose Escalation (BGB-A3055 + tislelizumab)
Arm group label:
Phase 1b (Dose Expansion):
Other name:
BGB-A317
Summary:
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.
Detailed description:
The primary objective of the study is to assess the safety and tolerability of BGB-A3055
alone or in combination with Tislelizumab during dose escalation and to determine the
recommended dose for expansion. During dose expansion, the primary objective will be to
assess preliminary anti-tumor activity and further characterize the safety of the
recommended dose for expansion.
. Around 318 participants will be enrolled in this study, and they will be assigned to
different treatment groups. Both the participants and their doctors will be aware of
which treatment group they are assigned to throughout the study.
The treatments, BGB-A3055 alone or in combination with Tislelizumab, will be administered
intravenously to evaluate their safety and determine the highest dose that can be
tolerated by participants. The study will be conducted at multiple medical centers
worldwide. The expected duration of participation in this study is two years. Treatment
will continue until participants no longer receive any benefits from the drugs,
experience excessive side effects, or decide to withdraw their consent.
Criteria for eligibility:
Criteria:
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.
Exclusion Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Iowa Hospitals and Clinics
Address:
City:
Iowa City
Zip:
52242
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:
Next Dallas
Address:
City:
Irving
Zip:
75039
Country:
United States
Status:
Recruiting
Facility:
Name:
Chris Obrien Lifehouse
Address:
City:
Camperdown
Zip:
2050
Country:
Australia
Status:
Recruiting
Facility:
Name:
Icon Cancer Centre South Brisbane
Address:
City:
South Brisbane
Zip:
4101
Country:
Australia
Status:
Recruiting
Facility:
Name:
Linear Clinical Research
Address:
City:
Nedlands
Zip:
6009
Country:
Australia
Status:
Recruiting
Facility:
Name:
Chongqing University Cancer Hospital
Address:
City:
Chongqing
Zip:
400030
Country:
China
Status:
Recruiting
Facility:
Name:
Fujian Cancer Hospital
Address:
City:
Fuzhou
Zip:
350014
Country:
China
Status:
Recruiting
Facility:
Name:
Liaoning Cancer Hospital and Institute
Address:
City:
Shenyang
Zip:
110042
Country:
China
Status:
Recruiting
Facility:
Name:
Tianjin Medical University Cancer Institute and Hospital
Address:
City:
Tianjin
Zip:
300060
Country:
China
Status:
Recruiting
Facility:
Name:
Centre de Lutte Contre Le Cancer Institut Bergonie
Address:
City:
Bordeaux
Zip:
33076
Country:
France
Status:
Recruiting
Facility:
Name:
Institut Curie
Address:
City:
Paris
Zip:
75005
Country:
France
Status:
Recruiting
Facility:
Name:
Ico Site Rene Gauducheau
Address:
City:
SaintHerblain
Zip:
44805
Country:
France
Status:
Recruiting
Start date:
August 21, 2023
Completion date:
February 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/NCT05935098
