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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-501177-39-00 | EU Trial (CTIS) Number | ||
| CTR20220453 | Other Identifier | ChinaDrugTrials |
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The purpose of this study is to assess the safety and tolerability of BGB-A445 alone and in combination with tislelizumab in participants with advanced solid tumors; and to determine the maximum tolerated dose(s) (MTD) or maximum administered dose(s) (MAD) and recommended Phase 2 doses (RP2D) of BGB-A445 alone and in combination with tislelizumab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1a: BGB-A445 Monotherapy | Experimental | Dose Escalation Part A: Participants will receive intravenous (IV) infusion of BGB-A445 in sequential cohorts of approximately 8 increasing dose levels on day 1 of each 21-day cycle |
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| Phase 1a: BGB-A445 + Tislelizumab Combination Therapy | Experimental | Dose Escalation Part B: Participants will receive IV infusion of BGB-A445 in sequential cohorts of approximately 6 increasing dose levels plus 200mg tislelizumab on day 1 of each 21-day cycle |
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| Phase 1b:BGB-A445 Monotherapy | Experimental | Dose Expansion Part A: Participants will receive recommended doses of IV BGB-A445 as determined from Phase 1a Dose Escalation; BGB-A445 will be evaluated in two tumor types |
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| Phase 1b: BGB-A445 + Tislelizumab and Chemotherapy Combination Therapy | Experimental | Dose Expansion Part B: Participants will receive recommended dose IV infusion of BGB-A445 plus 200mg tislelizumab and chemotherapy |
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| Phase 1b: BGB-A445 Monotherapy | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BGB-A445 | Drug | Administered as specified in the treatment arm |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1a: Number of Participants Experiencing Adverse Events (AEs) | Up to 90 days after the last dose of study drug(s) regardless of whether the participant starts a subsequent anticancer therapy | |
| Phase 1a: Number of Participants Experiencing Serious Adverse Events (SAEs) | Up to 90 days after the last dose of study drug(s) regardless of whether the participant starts a subsequent anticancer therapy | |
| Phase 1a: Number of Participants Experiencing AEs meeting protocol defined Dose-Limiting Toxicity (DLT) criteria | Up to 90 days after the last dose of study drug(s) regardless of whether the participant starts a subsequent anticancer therapy | |
| Phase 1a: Maximum Tolerated Dose (MTD) of BGB-A445 | The MTD is defined as the highest dose evaluated for which the estimated toxicity rate is closest to the target toxicity rate of 30% | Up to 30 days after the last dose of study drug(s) or before the initiation of a new anticancer treatment, whichever occurs first |
| Phase 1b: RP2D of BGB-A445 when Administered Alone | Up to 30 days after the last dose of study drug(s) or before the initiation of a new anticancer treatment, whichever occurs first | |
| Phase 1b: Overall Response Rate (ORR) as Assessed by the Investigator | ORR is defined as the proportion of participants who had confirmed complete response Complete Response (CR) or Partial Response (PR) | Up to 30 days after the last dose of study drug(s) or before the initiation of a new anticancer treatment, whichever occurs first |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1a: Overall Response Rate (ORR) as Assessed by the Investigator | Up to 30 days after the last dose of study drug(s) or before the initiation of a new anticancer treatment, whichever occurs first | |
| Phase 1a: Duration of Response (DOR) as Assessed by the Investigator |
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Key Inclusion Criteria:
1. Phase 1a (dose escalation): Participants with histologically or cytologically confirmed advanced, metastatic, unresectable solid tumors who have previously received standard systemic therapy or for whom treatment is not available, not tolerated or refused.
Enrollment will be limited to participants with advanced solid tumors for which there is clinical evidence of response to T cell based immuno-oncology agents (eg, anti PD 1) or other scientific evidence in support of an immunologically sensitive tumor type.
Participant has not received prior therapy targeting OX40 or any other T cell agonist therapy (prior checkpoint inhibitor therapy is allowed)
2. Phase 1b, the dose expansion phase, aims to include participants in specific tumor type cohorts who do not have access to standard systemic treatment, cannot tolerate it, or it is deemed inappropriate by the investigator. Cohort 1 focuses on non-small cell lung cancer (NSCLC) patients with advanced or metastatic disease, while Cohort 2 involves individuals with recurrent or metastatic head and neck squamous cell cancer (HNSCC). Cohort 3 includes participants with nasopharyngeal carcinoma (NPC), and Cohort 4 is for NSCLC patients with PD-L1 expression of at least 50%. Each cohort has specific eligibility criteria related to prior therapies, tumor characteristics, and treatment-free intervals.
3. Has at least 1 measurable lesion as defined per RECIST 1.1. The target lesion(s) selected have not been previously treated with local therapy OR the target lesion(s) selected that are within the field of prior local therapy have subsequently progressed as defined by RECIST 1.1 4. Participants should be able to provide tumor tissue sample 5. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1 and a life expectancy of ≥ 6 months.
6. Adequate organ function as indicated by the following laboratory values up to first dose of study drug
a. Participants must not have required blood transfusion or growth factor support ≤ 14 days before sample collection for the following:
Absolute neutrophil count ≥ 1.5 x 10^9/L
Platelet count ≥ 75 x 10^9/L
Hemoglobin ≥ 90 g/L
b. Estimated glomerular filtration rate (GFR) ≥ 60 mL/min/1.73 m^2 determined by the Cockcroft-Gault formula without correction for body surface area (BSA)
The estimated GFR for participants with renal cell carcinoma must be ≥ 30 mL/min/1.73 m^2 by the Cockcroft-Gault formula
c. Serum total bilirubin ≤ 1.5 x ULN (< 3 x ULN for participants with Gilbert syndrome) d. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN;
≤ 5 x ULN for participants with hepatocellular carcinoma or liver metastases
Key Exclusion Criteria:
Active leptomeningeal disease or uncontrolled brain metastasis. Participants with equivocal findings or with confirmed brain metastases are eligible for enrollment provided they are asymptomatic and radiologically stable without the need for corticosteroid treatment for at least 4 weeks prior to the first dose of study drug(s)
Active autoimmune diseases or history of autoimmune diseases that may relapse or history of life-threatening toxicity related to prior immune therapy, with the following exceptions:
Any active malignancy ≤ 2 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), with the following exceptions:
Any major surgical procedure occurring ≤ 28 days before the first dose of study drug(s). If surgical procedure occurs > 28 days, they must have recovered adequately from the toxicity
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | BeiGene | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Valkyrie Clinical Trials | Los Angeles | California | 90067 | United States | ||
| California Cancer Associates for Research & Excellence (cCARE) |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 30, 2026 | |
| Reset | Feb 19, 2026 | |
| Release | Mar 24, 2026 |
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Dose Expansion Part C: Participants will receive 1 dose level of BGB-A445
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| tislelizumab | Drug | Administered as specified in the treatment arm |
|
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| Up to 30 days after the last dose of study drug(s) or before the initiation of a new anticancer treatment, whichever occurs first |
| Phase 1a: Disease-Control Rate (DCR) as Assessed by the Investigator | Up to 30 days after the last dose of study drug(s) or before the initiation of a new anticancer treatment, whichever occurs first |
| Phase 1a: Serum Concentration of BGB-A445 | 60 minutes predose up to 72 hours postdose |
| Phase 1a: Serum Concentration of tislelizumab | 60 minutes predose up to 72 hours postdose |
| Phase 1a: Maximum Observed Plasma Concentration (Cmax) of BGB-A445 | 60 minutes predose up to 72 hours postdose |
| Phase 1a: Maximum Observed Plasma Concentration (Cmax) of tislelizumab | 60 minutes predose up to 72 hours postdose |
| Phase 1a: Minimum Observed Plasma Concentration (Cmin) of BGB-A445 | 60 minutes predose up to 72 hours postdose |
| Phase 1a: Minimum Observed Plasma Concentration (Cmin) of tislelizumab | 60 minutes predose up to 72 hours postdose |
| Phase 1a: Time to Maximum Plasma Concentration (Tmax) of BGB-A445 | 60 minutes predose up to 72 hours postdose |
| Phase 1a: Time to Maximum Plasma Concentration (Tmax) of tislelizumab | 60 minutes predose up to 72 hours postdose |
| Phase 1a: Area Under the Concentration-Time Curve of 0-21 Days (AUC0-21d) of BGB-A445 | 60 minutes predose up to 21 days postdose |
| Phase 1a: Immunogenic Responses to BGB-A445 as assessed through the detection of antidrug antibodies | Up to 30 days after the last dose of study drug(s) or before the initiation of a new anticancer treatment, whichever occurs first |
| Phase 1a: Immunogenic Responses to tislelizumab as assessed through the detection of antidrug antibodies | Up to 30 days after the last dose of study drug(s) or before the initiation of a new anticancer treatment, whichever occurs first |
| Phase 1b: Progression-free survival (PFS) as Assessed by the Investigator | Determined from investigator derived tumor assessments as per RECIST 1.1 | Up to 30 days after the last dose of study drug(s) or before the initiation of a new anticancer treatment, whichever occurs first |
| Phase 1b: Duration of Response (DOR) as Assessed by the Investigator | Up to 30 days after the last dose of study drug(s) or before the initiation of a new anticancer treatment, whichever occurs first |
| Phase 1b: Disease-Control Rate (DCR) as Assessed by the Investigator | Up to 30 days after the last dose of study drug(s) or before the initiation of a new anticancer treatment, whichever occurs first |
| Phase 1b: Number of Participants Experiencing Adverse Events (AEs) | Up to 90 days after the last dose of study drug(s) regardless of whether the participant starts a subsequent anticancer therapy |
| Phase 1b: Number of Participants Experiencing Serious Adverse Events (SAEs) | Up to 90 days after the last dose of study drug(s) regardless of whether the participant starts a subsequent anticancer therapy |
| Phase 1b: Serum Concentration of BGB-A445 | 60 minutes predose up to 72 hours postdose |
| Phase 1b: Maximum Observed Plasma Concentration (Cmax) of BGB-A445 | 60 minutes predose up to 72 hours postdose |
| Phase 1b: Minimum Observed Plasma Concentration (Cmin) of BGB-A445 | 60 minutes predose up to 72 hours postdose |
| Phase 1b: Time to Maximum Plasma Concentration (Tmax) of BGB-A445 | 60 minutes predose up to 72 hours postdose |
| Phase 1b: Area Under the Concentration-Time Curve of 0-21 Days (AUC0-21d) of BGB-A445 | 60 minutes predose up to 21 days postdose |
| Phase 1b: Immunogenic Responses to BGB-A445 as assessed through the detection of antidrug antibodies | Up to 30 days after the last dose of study drug(s) or before the initiation of a new anticancer treatment, whichever occurs first |
| San Diego |
| California |
| 92127 |
| United States |
| UPMC Hillman Cancer Center (Univ Of Pittsburgh) | Pittsburgh | Pennsylvania | 15232 | United States |
| Blacktown Cancer And Haematology Centre | Blacktown | New South Wales | 2148 | Australia |
| Pindara Private Hospital | Benowa | Queensland | 4217 | Australia |
| Princess Alexandra Hospital | Brisbane | Queensland | 4102 | Australia |
| Monash Health | Clayton | Victoria | 3168 | Australia |
| Peter Maccallum Cancer Centre | Melbourne | Victoria | 3000 | Australia |
| Nucleus Network | Melbourne | Victoria | 3004 | Australia |
| Linear Clinical Research | Nedlands | Western Australia | 6009 | Australia |
| Union Hospital Of Tongji Medical College, Huazhong University Of Science And Technology | Wuhan | Hubei | 430022 | China |
| The Second Xiangya Hospital Of Central South University | Changsha | Hunan | 410011 | China |
| Jinan Central Hospital | Jinan | Shandong | 250013 | China |
| Linyi Cancer Hospital | Linyi | Shandong | 276001 | China |
| Affiliated Zhongshan Hospital Of Fudan University | Shanghai | Shanghai Municipality | 200032 | China |
| Sir Run Run Shaw Hospital Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310000 | China |
| Zhejiang Cancer Hospital | Hangzhou | Zhejiang | 310022 | China |
| University of Malaya Medical Centre | Kuala Lumpur | 50603 | Malaysia |
| Sarawak General Hospital | Kuching | 93586 | Malaysia |
| Auckland City Hospital | Auckland | 1023 | New Zealand |
| National Cancer Center (NCC) | Goyang-si | Gyeonggi-do | 10408 | South Korea |
| Cha Bundang Medical Center, Cha University | Gyeonggido | Gyeonggi-do | 13496 | South Korea |
| The Catholic University of Korea, St. Vincent's Hospital | Suwon | Gyeonggi-do | 16247 | South Korea |
| Seoul National University Bundang Hospital | Seongnam-si | Gyeonggido | 13620 | South Korea |
| Severance Hospital Yonsei University Health System | Seoul | Seoul Teugbyeolsi | 03722 | South Korea |
| Changhua Christian Hospital | Changhua | NAP | 500-06 | Taiwan |
| National Cheng Kung University Hospital | Tainan | 704 | Taiwan |
| King Chulalongkorn Memorial Hospital (Chulalongkorn University) | Bangkok | 10330 | Thailand |
| Ramathibodi Hospital Mahidol University | Bangkok | 10400 | Thailand |
| Srinagarind Hospital (Khon Kaen University) | Muang | 40002 | Thailand |
| Unrelease | Mar 27, 2026 |
| Release | Mar 30, 2026 |
| Reset | Apr 16, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 30, 2026 | Feb 19, 2026 | |||
| Mar 24, 2026 | Mar 27, 2026 | |||
| Mar 30, 2026 | Apr 16, 2026 |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D000077274 | Nasopharyngeal Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D006258 | Head and Neck Neoplasms |
| D009303 | Nasopharyngeal Neoplasms |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D009302 | Nasopharyngeal Diseases |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| C000707970 | tislelizumab |
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