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Trial Title:
A Study of BGB-R046 as Monotherapy and in Combination With Tislelizumab in Solid Tumors
NCT ID:
NCT06487858
Condition:
Solid Tumor
Conditions: Official terms:
Neoplasms
Tislelizumab
Conditions: Keywords:
BGB-R046
First-in-human
Advanced solid tumor
Anti-Programmed Death-1 (Anti-PD1)
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
BGB-R046
Description:
Intravenous administration
Arm group label:
Phase 1a: Part A: Dose Escalation Monotherapy
Arm group label:
Phase 1a: Part B: Dose Escalation Combination Therapy
Arm group label:
Phase 1b: Dose Expansion
Intervention type:
Drug
Intervention name:
Tislelizumab
Description:
Intravenous administration
Arm group label:
Phase 1a: Part B: Dose Escalation Combination Therapy
Arm group label:
Phase 1b: Dose Expansion
Summary:
This is a first-in-human (FIH) study that will evaluate the safety, tolerability,
pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BGB-R046
as a single agent and in combination with tislelizumab (BGB-A317) in participants with
advanced or metastatic immune-sensitive solid tumors.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Participants able to provide a signed and dated written informed consent prior to
any study-specific procedures, sampling, or data collection
- Participants with histologically or cytologically confirmed advanced, metastatic,
and unresectable solid tumors who have previously received standard systemic therapy
or for whom standard treatment is not available, not tolerated, or determined not
appropriate based on the investigator's judgement
- ≥ 1 measurable lesion per RECIST v1.1
- Able to provide an archived tumor tissue sample
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1
- Adequate organ function
- Life expectancy >12 weeks as determined by the investigator
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 (eg, resected basal or squamous cell skin
cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast)
- 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 drug(s)
- History of interstitial lung disease, noninfectious pneumonitis (including immune
mediated), or uncontrolled lung diseases including pulmonary fibrosis, or acute lung
diseases.
- Experienced ≥ Grade 3 imAE(s) on prior immuno-oncology agent (anti-PD-1, anti CTLA4,
or other experimental drugs)
- Uncontrolled diabetes > Grade 1 laboratory test abnormalities in potassium, sodium,
or corrected calcium despite standard medical management, or ≥ Grade 3
hypoalbuminemia ≤ 14 days before the first dose of study drug(s).
- Infection (including tuberculosis infection, or other) requiring systemic (oral or
intravenous) antibacterial, antifungal, or antiviral therapy ≤ 14 days before the
first dose of study drug(s)
- Immunodeficiency as assessed by the investigator to be not suitable for treatment
with immune modulating anticancer agents
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:
Fujian Cancer Hospital
Address:
City:
Fuzhou
Zip:
350014
Country:
China
Status:
Recruiting
Facility:
Name:
Guangxi Medical University Cancer Hospital
Address:
City:
Nanning
Zip:
530021
Country:
China
Status:
Recruiting
Facility:
Name:
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Address:
City:
Wuhan
Zip:
430022
Country:
China
Status:
Recruiting
Facility:
Name:
Jinan Central Hospital
Address:
City:
Jinan
Zip:
250013
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Jining No Peoples Hospital West Branch
Address:
City:
Jining
Zip:
272000
Country:
China
Status:
Recruiting
Facility:
Name:
West China Hospital, Sichuan University
Address:
City:
Chengdu
Zip:
610041
Country:
China
Status:
Not yet recruiting
Start date:
July 16, 2024
Completion date:
December 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/NCT06487858
