Clinical trial NCT05981703: A Study Investigating BGB-26808 Alone or in Combination With Tislelizumab in Participants With Advanced Solid Tumors
Official title: A Phase 1 Study Investigating the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of HPK1 Inhibitor BGB-26808 Alone or in Combination With Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Advanced Solid Tumor
Solid Tumor
Keywords: advanced solid tumor
BGB-26808
BGB-A317
Tislelizumab
PD1
HPK1
Lead sponsor: BeiGene
Sponsor class: INDUSTRY
First posted: 2023-08-08
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This is an open-label, multicenter, and nonrandomized dose escalation and dose expansion study to evaluate BGB-26808 as monotherapy or in combination with tislelizumab in participants with advanced solid tumors. The main purpose of this study is to explore the recommended dosing for BGB-26808.


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 ≤ 1.
3. Phase 1a: Participants with histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors that are immune-sensitive who have previously received standard systemic therapy, or for whom treatment is not available or not tolerated, or for whom treatment is determined not appropriate based on investigator's judgment and who have not received prior therapy targeting hematopoietic progenitor kinase 1 (HPK1).
4. Phase 1b: Participants with histologically confirmed locally advanced unresectable or metastatic tumor types and who have not had prior systemic treatment. Participants who received prior systemic therapy in a neo-adjuvant or adjuvant setting with curative intent for nonmetastatic disease must have experienced a disease-free interval of ≥ 6 months from the last dose of systemic therapy prior to the first dose of study treatments.
5. ≥ 1 measurable lesion per RECIST v1.1.
6. Able to provide an archived tumor tissue sample.
7. Adequate organ function.
8. Females of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study, and for ≥ 90 days after the last dose of BGB-26808, or for ≥ 120 days after the last dose of tislelizumab, or for ≥ 180 days after the last dose of chemotherapy.
9. Nonsterile males must be willing to use a highly effective method of birth control for the duration of the study treatment period and for ≥ 90 days after the last dose of BGB-26808, or for ≥ 120 days after the last dose of tislelizumab, or for ≥ 180 days after the last dose of chemotherapy.

Exclusion Criteria:

1. Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-TIGIT, anti-CTLA4, or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways.
2. Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention.
3. Clinically significant bleeding from the gastrointestinal tract within 28 days before the first dose of study treatment(s).
4. Active leptomeningeal disease or uncontrolled, untreated brain metastasis.
5. Active autoimmune diseases or history of autoimmune diseases that may relapse
6. Any malignancy ≤ 3 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).
7. 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 treatment(s).
8. History of interstitial lung disease, noninfectious pneumonitis, or uncontrolled lung diseases including pulmonary fibrosis, acute lung diseases.
9. Uncontrolled diabetes.
10. 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.

Primary outcomes:
measure: Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: From the first dose of study drug(s) to 90 days after the last dose or initiation of a new anticancer therapy, whichever occurs first; up to approximately 12 months
measure: Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BGB-26808
timeFrame: Approximately 1 month
measure: Phase 1a: Recommended Dose for Expansion (RDFE) of BGB-26808
timeFrame: Approximately 1 month
measure: Phase 1b: Overall Response Rate (ORR)
timeFrame: Approximately 6 months
Secondary outcomes:
measure: Phase 1a: ORR
timeFrame: Approximately 6 months
measure: Phase 1a and 1b: Duration of Response (DOR)
timeFrame: Approximately 9 months
measure: Phase 1a and 1b: Disease Control Rate (DCR)
timeFrame: Approximately 6 months
measure: Phase 1a and 1b: Clinical Benefit Rate (CBR)
timeFrame: Approximately 6 months
measure: Phase 1b: Progression Free Survival (PFS)
timeFrame: Approximately 9 months
measure: Phase 1a: Maximum observed plasma concentration (Cmax) for BGB-26808
timeFrame: Approximately 1 month
measure: Phase 1a: Minimum observed plasma concentration (Cmin) for BGB-26808
timeFrame: Approximately 6 months
measure: Phase 1a: Time to maximum plasma concentration (Tmax) for BGB-26808
timeFrame: Approximately 1 month
measure: Phase 1a: Half-life (t1/2) for BGB-26808
timeFrame: Approximately 1 month
measure: Phase 1a: Area under the concentration-time curve (AUC) for BGB-26808
timeFrame: Approximately 1 month
measure: Phase 1a: Apparent clearance (CL/F) for BGB-26808
timeFrame: Approximately 1 month
measure: Phase 1a: Apparent volume of distribution (Vz/F) for BGB-26808
timeFrame: Approximately 1 month
measure: Phase 1a: Accumulation ratio for BGB-26808
timeFrame: Approximately 1 month
measure: Phase 1b: Plasma concentrations of BGB-26808
timeFrame: Approximately 6 months
measure: Phase 1b: Number of Participants with AEs and SAEs
timeFrame: From the first dose of study drug(s) to 90 days after the last dose or initiation of a new anticancer therapy, whichever occurs first; up to approximately 12 months
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University, Yale Cancer Center
state: Connecticut
city: Miami
country: United States
facility: Sylvester Cancer Center, University of Miami
state: Florida
city: Hackensack
country: United States
facility: John Theurer Cancer Center Hackensack University Medical Center
state: New Jersey
city: New York
country: United States
facility: Icahn School of Medicine At Mount Sinai
state: New York
city: Portland
country: United States
facility: Providence Portland Medical Center
state: Oregon
city: Houston
country: United States
facility: The University of Texas Md Anderson Cancer Center
state: Texas
city: Miranda
country: Australia
facility: Southside Cancer Care
state: New South Wales
city: North Ryde
country: Australia
facility: Macquarie University
state: New South Wales
city: Kurralta Park
country: Australia
facility: Icon Cancer Centre Kurralta Park
state: South Australia
city: Nedlands
country: Australia
facility: Linear Clinical Research
state: Western Australia
city: Hefei
country: China
facility: The First Affiliated Hospital of Anhui Medical Universitygaoxin Branch
state: Anhui
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
state: Heilongjiang
city: Wuhan
country: China
facility: Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
state: Hubei
city: Wuhan
country: China
facility: Hubei Cancer Hospital
state: Hubei
city: Shenyang
country: China
facility: The First Hospital of China Medical University Hunnan Branch
state: Liaoning
city: Jining
country: China
facility: Jining No Peoples Hospital West Branch
state: Shandong
city: Yantai
country: China
facility: Yantai Yuhuangding Hospital
state: Shandong
city: Shanghai
country: China
facility: Shanghai East Hospital Branch Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital
state: Shanghai
city: Chengdu
country: China
facility: Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
state: Sichuan
city: Hangzhou
country: China
facility: Hangzhou First Peoples Hospital
state: Zhejiang
city: Taizhou
country: China
facility: Taizhou Hospital of Zhejiang Province (East)
state: Zhejiang
city: Auckland
country: New Zealand
facility: Auckland City Hospital
Study officials:
affiliation: BeiGene
name: Study Director
role: STUDY_DIRECTOR
References: