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Trial Title:
A First-in-Human Study of BGB-C354 Alone and in Combination With Tislelizumab in Participants With Advanced Solid Tumors
NCT ID:
NCT06422520
Condition:
Advanced Solid Tumor
Conditions: Official terms:
Neoplasms
Tislelizumab
Conditions: Keywords:
BGB-C354
Tislelizumab
First-in-human
Advanced solid tumor
Anti-PD-1 Monoclonal Antibody
B7H3
antibody drug conjugate
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-C354
Description:
Administered by intravenous infusion
Arm group label:
Phase 1a: Part A (Monotherapy Dose Escalation)
Arm group label:
Phase 1a: Part B (Safety Expansion)
Arm group label:
Phase 1b: Part C (Monotherapy Expansion)
Arm group label:
Phase 1b: Part D (Combination Therapy Expansion)
Intervention type:
Drug
Intervention name:
Tislelizumab
Description:
Administered by intravenous infusion
Arm group label:
Phase 1b: Part D (Combination Therapy Expansion)
Summary:
This is a first-in-human, Phase 1a/1b study to evaluate the safety, tolerability,
pharmacokinetics, and preliminary antitumor activity of BGB-C354 alone and in combination
with tislelizumab in participants with advanced solid tumors.
Study details include:
- The study will be conducted in 2 phases: Phase 1a (Monotherapy Dose Escalation and
Safety Expansion) and Phase 1b (Dose Expansion).
- The visit frequency will be approximately every 21 days during study treatment.
- The study duration is estimated to be approximately 5 years.
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 of 0 or 1.
3. Participants with histologically or cytologically confirmed advanced, metastatic, or
unresectable solid tumors, whose cancer is not amenable to therapy with curative
intent:
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 ≥ 7 months after the last
dose of study drug(s).
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 ≥ 4 months after the last
dose of study drug(s).
Exclusion Criteria:
1. Prior treatment with B7H3-targeted therapy.
2. For Part B and Phase 1b: Prior treatment with antibody drug conjugates (ADCs) with
topoisomerase I inhibitor payload (for Phase 1b, unless otherwise specified for
specific cohorts).
3. Participants with spinal cord compressions, active leptomeningeal disease or
uncontrolled, or untreated brain metastasis
4. Any malignancy ≤ 2 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).
5. History of interstitial lung disease, ≥ Grade 2 noninfectious pneumonitis, oxygen
saturation at rest < 92%, or requirement for supplemental oxygen at baseline
6. Uncontrolled diabetes, or > Grade 1 laboratory test abnormalities in potassium,
sodium, or corrected calcium levels despite standard medical management ≤ 14 days
before the first dose of study drug(s).
7. 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:
Next Oncology
Address:
City:
San Antonio
Zip:
78229
Country:
United States
Status:
Recruiting
Facility:
Name:
Westmead Hospital
Address:
City:
Westmead
Zip:
2145
Country:
Australia
Status:
Recruiting
Facility:
Name:
One Clinical Research
Address:
City:
Nedlands
Zip:
6009
Country:
Australia
Status:
Recruiting
Start date:
July 5, 2024
Completion date:
November 30, 2026
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/NCT06422520
