Advanced Solid TumorPhase 1NCT04215978
Safety and Preliminary Effectiveness of BGB-A445 in Combination With Tislelizumab in Participants With Advanced Solid Tumors
A Phase 1 study testing BGB-A445 and tislelizumab in people with Advanced Solid Tumor and Non Small Cell Lung Cancer, run by BeiGene at 30 sites in 8 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor, Non Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma (HNSCC)
- What is being tested?
- BGB-A445 and tislelizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 30 sitesin 8 countries
- Study dates
- 30 Jan 2020to 24 Jan 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
- 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
- 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
Who cannot join
- 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:
- Controlled type 1 diabetes
- Hypothyroidism (provided it is managed with hormone-replacement therapy only)
- Controlled celiac disease
- Skin diseases not requiring systemic treatment (eg, vitiligo, psoriasis, or alopecia)
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- Any other disease that is not expected to recur in the absence of external triggering factors (requires consultation with the medical monitor prior to enrollment)
- 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:
- Adrenal replacement steroid (dose ≤ 10 mg daily of prednisone or equivalent)
- Topical, ocular, intra-articular, intranasal, or inhalational corticosteroid with minimal systemic absorption
- Short course (≤ 7 days) of corticosteroid prescribed prophylactically (eg, for contrast dye allergy) or for the treatment of a nonautoimmune condition (eg, delayed-type hypersensitivity reaction caused by contact allergen)
- 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.
Trial locations and contacts
30 sites in 8 countries.
30 sites in 8 countries
Australia7 sites
Pindara Private Hospital
Benowa, Queensland, 4217
Blacktown Cancer And Haematology Centre
Blacktown, New South Wales, 2148
Princess Alexandra Hospital
Brisbane, Queensland, 4102
Monash Health
Clayton, Victoria, 3168
Peter Maccallum Cancer Centre
Melbourne, Victoria, 3000
Nucleus Network
Melbourne, Victoria, 3004
Linear Clinical Research
Nedlands, Western Australia, 6009
China7 sites
The Second Xiangya Hospital Of Central South University
Changsha, Hunan, 410011
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Jinan Central Hospital
Jinan, Shandong, 250013
Linyi Cancer Hospital
Linyi, Shandong, 276001
Affiliated Zhongshan Hospital Of Fudan University
Shanghai, Shanghai Municipality, 200032
Union Hospital Of Tongji Medical College, Huazhong University Of Science And Technology
Wuhan, Hubei, 430022
South Korea5 sites
National Cancer Center (NCC)
Goyang-si, Gyeonggi-do, 10408
Cha Bundang Medical Center, Cha University
Gyeonggido, Gyeonggi-do, 13496
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggido, 13620
Severance Hospital Yonsei University Health System
Seoul, Seoul Teugbyeolsi, 03722
The Catholic University of Korea, St. Vincent's Hospital
Suwon, Gyeonggi-do, 16247
United States3 sites
Valkyrie Clinical Trials
Los Angeles, California, 90067
UPMC Hillman Cancer Center (Univ Of Pittsburgh)
Pittsburgh, Pennsylvania, 15232
California Cancer Associates for Research & Excellence (cCARE)
San Diego, California, 92127
Thailand3 sites
King Chulalongkorn Memorial Hospital (Chulalongkorn University)
Bangkok, 10330
Ramathibodi Hospital Mahidol University
Bangkok, 10400
Srinagarind Hospital (Khon Kaen University)
Muang, 40002
Malaysia2 sites
University of Malaya Medical Centre
Kuala Lumpur, 50603
Sarawak General Hospital
Kuching, 93586
Taiwan2 sites
Changhua Christian Hospital
Changhua, NAP, 500-06
National Cheng Kung University Hospital
Tainan, 704
About this study
Official title: Phase 1 Study Investigating the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of the Anti OX40 Agonist Monoclonal Antibody BGB-A445 in Combination With the Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients With Advanced Solid Tumors
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.
- Conditions
- Advanced Solid Tumor, Non Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma (HNSCC), Nasopharyngeal Carcinoma (NPC)
- Being tested
- BGB-A445, tislelizumab
- Keywords
- OX40, PD-1
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Squamous Cell Carcinoma of Head and Neck, Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BGB-A445Drug
Also called Gimistotug
Administered as specified in the treatment arm
tislelizumabDrug
Also called BGB-A317
Administered as specified in the treatment arm
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: BGB-A445 |
| 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 Receives: Drug: BGB-A445; Drug: tislelizumab |
| 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 Receives: Drug: BGB-A445 |
| 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 Receives: Drug: BGB-A445; Drug: tislelizumab |
| Phase 1b: BGB-A445 Monotherapy | Experimental | Dose Expansion Part C: Participants will receive 1 dose level of BGB-A445 Receives: Drug: BGB-A445 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1a: Number of Participants Experiencing Adverse Events (AEs)
Measured: 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)
Measured: 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
Measured: 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%
Measured: 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
Measured: 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)
Measured: Up to 30 days after the last dose of study drug(s) or before the initiation of a new anticancer treatment, whichever occurs first
Secondary outcomes (25)
Phase 1a: Overall Response Rate (ORR) as Assessed by the Investigator
Measured: 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
Measured: 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
Measured: 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
Measured: 60 minutes predose up to 72 hours postdose
Phase 1a: Serum Concentration of tislelizumab
Measured: 60 minutes predose up to 72 hours postdose
Phase 1a: Maximum Observed Plasma Concentration (Cmax) of BGB-A445
Measured: 60 minutes predose up to 72 hours postdose
Phase 1a: Maximum Observed Plasma Concentration (Cmax) of tislelizumab
Measured: 60 minutes predose up to 72 hours postdose
Phase 1a: Minimum Observed Plasma Concentration (Cmin) of BGB-A445
Measured: 60 minutes predose up to 72 hours postdose
Phase 1a: Minimum Observed Plasma Concentration (Cmin) of tislelizumab
Measured: 60 minutes predose up to 72 hours postdose
Phase 1a: Time to Maximum Plasma Concentration (Tmax) of BGB-A445
Measured: 60 minutes predose up to 72 hours postdose
Phase 1a: Time to Maximum Plasma Concentration (Tmax) of tislelizumab
Measured: 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
Measured: 60 minutes predose up to 21 days postdose
Phase 1a: Immunogenic Responses to BGB-A445 as assessed through the detection of antidrug antibodies
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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
Measured: 60 minutes predose up to 72 hours postdose
Phase 1b: Maximum Observed Plasma Concentration (Cmax) of BGB-A445
Measured: 60 minutes predose up to 72 hours postdose
Phase 1b: Minimum Observed Plasma Concentration (Cmin) of BGB-A445
Measured: 60 minutes predose up to 72 hours postdose
Phase 1b: Time to Maximum Plasma Concentration (Tmax) of BGB-A445
Measured: 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
Measured: 60 minutes predose up to 21 days postdose
Phase 1b: Immunogenic Responses to BGB-A445 as assessed through the detection of antidrug antibodies
Measured: Up to 30 days after the last dose of study drug(s) or before the initiation of a new anticancer treatment, whichever occurs first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2020
- Study start30 Jan 2020
- Primary completion24 Jan 2025
- Study completion24 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- More trials run by BeiGeneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- BeiGene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, BeiGene
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04215978
- Sponsor's protocol ID
- BGB-A317-A445-101
- Other IDs
- 2022-501177-39-00, CTR20220453
- Status last verified
- Feb 2025
- First submitted
- 30 Dec 2019
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study Investigating the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of the Anti OX40 Agonist Monoclonal Antibody BGB-A445 in Combination With the Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT04215978
- Acronym / sponsor ID
- BGB-A317-A445-101
- Conditions
- Advanced Solid Tumor, Non Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma (HNSCC), Nasopharyngeal Carcinoma (NPC)
- Keywords
- OX40, PD-1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- BeiGeneIndustry (pharma, biotech, devices)
- Study start
- 30 Jan 2020 (actual)
- Primary completion
- 24 Jan 2025 (actual)
- Study completion
- 24 Jan 2025 (actual)
- First posted
- 2 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Phase 1a: BGB-A445 Monotherapy | Experimental | Drug: BGB-A445Dose 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 |
| Phase 1a: BGB-A445 + Tislelizumab Combination Therapy | Experimental | Drug: BGB-A445, Drug: tislelizumabDose 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 |
| Phase 1b:BGB-A445 Monotherapy | Experimental | Drug: BGB-A445Dose 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 |
| Phase 1b: BGB-A445 + Tislelizumab and Chemotherapy Combination Therapy | Experimental | Drug: BGB-A445, Drug: tislelizumabDose Expansion Part B: Participants will receive recommended dose IV infusion of BGB-A445 plus 200mg tislelizumab and chemotherapy |
| Phase 1b: BGB-A445 Monotherapy | Experimental | Drug: BGB-A445Dose Expansion Part C: Participants will receive 1 dose level of BGB-A445 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BGB-A445Also: GimistotugAdministered as specified in the treatment arm | Drug | Phase 1a: BGB-A445 + Tislelizumab Combination Therapy, Phase 1a: BGB-A445 Monotherapy, Phase 1b: BGB-A445 + Tislelizumab and Chemotherapy Combination Therapy, Phase 1b: BGB-A445 Monotherapy, Phase 1b:BGB-A445 Monotherapy |
| tislelizumabAlso: BGB-A317Administered as specified in the treatment arm | Drug | Phase 1a: BGB-A445 + Tislelizumab Combination Therapy, Phase 1b: BGB-A445 + Tislelizumab and Chemotherapy Combination Therapy |
Primary outcome
Phase 1a: Number of Participants Experiencing Adverse Events (AEs)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: Up to 30 days after the last dose of study drug(s) or before the initiation of a new anticancer treatment, whichever occurs first
The MTD is defined as the highest dose evaluated for which the estimated toxicity rate is closest to the target toxicity rate of 30%
Phase 1b: RP2D of BGB-A445 when Administered Alone
Time frame: 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
Time frame: Up to 30 days after the last dose of study drug(s) or before the initiation of a new anticancer treatment, whichever occurs first
ORR is defined as the proportion of participants who had confirmed complete response Complete Response (CR) or Partial Response (PR)
25 secondary outcomes
Phase 1a: Overall Response Rate (ORR) as Assessed by the Investigator
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 60 minutes predose up to 72 hours postdose
Phase 1a: Serum Concentration of tislelizumab
Time frame: 60 minutes predose up to 72 hours postdose
Phase 1a: Maximum Observed Plasma Concentration (Cmax) of BGB-A445
Time frame: 60 minutes predose up to 72 hours postdose
Phase 1a: Maximum Observed Plasma Concentration (Cmax) of tislelizumab
Time frame: 60 minutes predose up to 72 hours postdose
Phase 1a: Minimum Observed Plasma Concentration (Cmin) of BGB-A445
Time frame: 60 minutes predose up to 72 hours postdose
Phase 1a: Minimum Observed Plasma Concentration (Cmin) of tislelizumab
Time frame: 60 minutes predose up to 72 hours postdose
Phase 1a: Time to Maximum Plasma Concentration (Tmax) of BGB-A445
Time frame: 60 minutes predose up to 72 hours postdose
Phase 1a: Time to Maximum Plasma Concentration (Tmax) of tislelizumab
Time frame: 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
Time frame: 60 minutes predose up to 21 days postdose
Phase 1a: Immunogenic Responses to BGB-A445 as assessed through the detection of antidrug antibodies
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 60 minutes predose up to 72 hours postdose
Phase 1b: Maximum Observed Plasma Concentration (Cmax) of BGB-A445
Time frame: 60 minutes predose up to 72 hours postdose
Phase 1b: Minimum Observed Plasma Concentration (Cmin) of BGB-A445
Time frame: 60 minutes predose up to 72 hours postdose
Phase 1b: Time to Maximum Plasma Concentration (Tmax) of BGB-A445
Time frame: 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
Time frame: 60 minutes predose up to 21 days postdose
Phase 1b: Immunogenic Responses to BGB-A445 as assessed through the detection of antidrug antibodies
Time frame: Up to 30 days after the last dose of study drug(s) or before the initiation of a new anticancer treatment, whichever occurs first
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
BeiGene
30 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BGB-A445 and tislelizumab in people with Advanced Solid Tumor and Non Small Cell Lung Cancer, run by BeiGene at 30 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in Australia, China, South Korea, United States, Thailand and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1a: Number of Participants Experiencing Adverse Events (AEs) (time frame: Up to 90 days after the last dose of study drug(s) regardless of whether the participant starts a subsequent anticancer therapy). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025.