Clinical trial NCT05935098: BGB-A3055 Alone and in Combination With Tislelizumab in Participants With Solid Tumors
Official title: A Phase 1a/1b Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BGB-A3055, Alone and in Combination With Tislelizumab in Patients With Selected Advanced or Metastatic Solid Tumors
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Advanced Solid Tumor
Metastatic Solid Tumor
Solid Tumor
Keywords: BGB-A3055
Tislelizumab
Advanced solid tumors
Safety monitoring
Monoclonal antibody
Preliminary antitumor activity
Metastatic cancer
Metastatic Solid Tumor
PD1
CCR8
Lead sponsor: BeiGene
Sponsor class: INDUSTRY
First posted: 2023-07-07
Enrollment: 263
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate how safe and well-tolerated the treatment is, how the body processes it, how it works on the tumors, and whether it shows early signs of fighting cancer in people with certain advanced or metastatic solid tumors.

Key details of the study include:

* The study is expected to last about 36 months.
* Participants will receive treatment until they either no longer benefit from the treatment, experience side effects that are too severe, or choose to stop participating.


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 within 3 days before the first dose of study drug(s) and have adequate organ function.
3. Participants with histologically confirmed advanced or metastatic solid tumors associated with high CCR8 and who have previously received adequate available standard systemic therapy or for whom treatment is not available or not tolerated and who have not received 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 archival tumor tissue samples (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.
6. Females of childbearing potential and nonsterile males must be willing to use a highly effective method of birth control for the duration of the study, and for ≥ 120 days after the last dose of BGB-A3055 or tislelizumab (whichever is later), or up to 9 months after the last dose of chemotherapy, whichever is later. Females of childbearing potential must also have a negative urine or serum pregnancy test result ≤ 7 days before the first dose of study drug(s).

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. Participants with hepatitis B infection with HBV DNA ≥ 500 IU/mL (or ≥ 2500 copies/mL). Participants with active hepatitis C, and participants with HIV infection.

   Note: Participants with chronic hepatitis B infection or resolved hepatitis B infection (HBV DNA \< 500 IU/mL or \< 2500 copies/mL) and considered stable are eligible. 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.
6. Grade 3 immune-mediated adverse events on prior immune-oncology agent.
7. Cardiovascular risk factors, including but not limited to pulmonary embolism ≤ 28 days or history of acute myocardial infarction or heart failure ≤ 6 months before the first dose of study drug(s).
8. Uncontrolled diabetes.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Phase 1a: Number of participants with adverse events (AEs)
timeFrame: Up to 2 Years
measure: Phase 1a: Maximum tolerated dose (MTD) or maximum administered dose (MAD) of BGB-A3055
timeFrame: Up to 2 Years
measure: Phase 1a: Recommended dose for expansion (RDFE) of BGB-A3055 alone or in combination with tislelizumab
timeFrame: Up to 2 Years
measure: Phase 1b (Dose Expansion): Objective Response Rate (ORR)
timeFrame: Up to 2 Years
Secondary outcomes:
measure: Phase 1a: ORR
timeFrame: Up to 2 Years
measure: Time to Response (TTR)
timeFrame: Up to 2 Years
measure: Duration of Response (DOR)
timeFrame: Up to 2 Years
measure: Disease Control Rate (DCR)
timeFrame: Up to 2 Years
measure: Clinical Benefit Rate (CBR)
timeFrame: Up to 2 Years
measure: Number of participants with anti-drug antibodies (ADAs) against BGB-A3055
timeFrame: Up to 2 Years
measure: Serum concentration of BGB-A3055 at specified time points
timeFrame: Up to 2 Years
measure: Phase 1b: Progression-Free Survival (PFS)
timeFrame: Up to 2 Years
measure: Phase 1b: Number of participants with adverse events (AEs)
timeFrame: Up to 2 Years
measure: Phase 1b: Association of CCR8 expression with clinical efficacy
timeFrame: Up to 2 Years
measure: Phase 1b: Association of PD-L1 expression with clinical efficacy
timeFrame: Up to 2 Years
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Advent Health Cancer Institute
state: Florida
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Hackensack
country: United States
facility: John Theurer Cancer Center Hackensack University Medical Center
state: New Jersey
city: Houston
country: United States
facility: The University of Texas Md Anderson Cancer Center
state: Texas
city: Irving
country: United States
facility: Next Dallas
state: Texas
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center
state: Washington
city: Camperdown
country: Australia
facility: Chris Obrien Lifehouse
state: New South Wales
city: South Brisbane
country: Australia
facility: Icon Cancer Centre South Brisbane
state: Queensland
city: Nedlands
country: Australia
facility: Linear Clinical Research
state: Western Australia
city: Chongqing
country: China
facility: Chongqing University Cancer Hospital
state: Chongqing
city: Fuzhou
country: China
facility: Fujian Cancer Hospital
state: Fujian
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
city: Shenyang
country: China
facility: Liaoning Cancer Hospital and Institute
state: Liaoning
city: Shanghai
country: China
facility: Rui Jin Hospital Shanghai Jiao Tong University School of Medicinejiading Branch
state: Shanghai
city: Changzhi
country: China
facility: Changzhi Peoples Hospital
state: Shanxi
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
state: Tianjin
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University School of Medicine
state: Zhejiang
city: Bordeaux
country: France
facility: Centre de Lutte Contre Le Cancer Institut Bergonie
city: Paris
country: France
facility: Institut Curie
city: SaintHerblain
country: France
facility: Ico Site Rene Gauducheau
city: BundangGu SeongnamSi
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
city: GangnamGu
country: Korea, Republic of
facility: Samsung Medical Center
state: Seoul Teugbyeolsi
city: SeodaemunGu
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Seoul Teugbyeolsi
city: SongpaGu
country: Korea, Republic of
facility: Asan Medical Center
state: Seoul Teugbyeolsi
Study officials:
affiliation: BeiGene
name: Study Director
role: STUDY_DIRECTOR
References: