- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04215978
Safety and Preliminary Effectiveness of BGB-A445 in Combination With Tislelizumab in Participants With Advanced Solid Tumors
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: BeiGene
- Phone Number: 1-877-828-5568
- Email: clinicaltrials@beigene.com
Study Locations
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New South Wales
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Blacktown, New South Wales, Australia, 2148
- Blacktown Cancer and Haematology Centre
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Queensland
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Benowa, Queensland, Australia, 4217
- Pindara Private Hospital
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Brisbane, Queensland, Australia, 4102
- Princess Alexandra Hospital
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Victoria
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Clayton, Victoria, Australia, 3168
- Monash Health
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Melbourne, Victoria, Australia, 3000
- Peter MacCallum Cancer Centre
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Ontario
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Hamilton, Ontario, Canada, L8V 5C2
- Juravinski Cancer Centre
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Gyeonggido, Korea, Republic of, 13496
- CHA Bundang Medical Center, CHA University
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Gyeonggido
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Goyangsi, Gyeonggido, Korea, Republic of, 10408
- National Cancer Center
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Seongnamsi, Gyeonggido, Korea, Republic of, 13620
- Seoul National University Bundang Hospital
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Suwonsi, Gyeonggido, Korea, Republic of, 16247
- The Catholic University of Korea, St Vincents Hospital
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Suwonsi, Gyeonggido, Korea, Republic of, 16499
- Ajou University Hospital
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Seoul Teugbyeolsi
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Seoul, Seoul Teugbyeolsi, Korea, Republic of, 03722
- Severance Hospital Yonsei University Health System
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Kuala Lumpur, Malaysia, 56000
- Universiti Kebangsaan Malaysia Medical Centre (Ukmmc)
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Auckland, New Zealand, 1023
- Auckland City Hospital
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Muang, Thailand, 50200
- Maharaj Nakorn Chiang Mai Hospital (Chiang Mai University)
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Mueang, Thailand, 34000
- Sunpasitthiprasong Hospital
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California
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Encinitas, California, United States, 92024
- California Cancer Associates For Research and Excellence, Ccare Encinitas
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Los Angeles, California, United States, 90067
- Valkyrie Clinical Trials
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San Marcos, California, United States, 92069
- California Cancer Associates For Research and Excellence, Inc
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Indiana
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Fort Wayne, Indiana, United States, 46804
- Fort Wayne Medical Oncology and Hematology
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15232
- Upmc Hillman Cancer Center(Univ of Pittsburgh)
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Washington
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Spokane Valley, Washington, United States, 99208
- Summit Cancer Centers
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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:
- 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)
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Phase 1a: BGB-A445 Monotherapy
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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Administered as specified in the treatment arm
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Experimental: Phase 1a: BGB-A445 + Tislelizumab Combination Therapy
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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Administered as specified in the treatment arm
Administered as specified in the treatment arm
Other Names:
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Experimental: Phase 1b:BGB-A445 Monotherapy
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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Administered as specified in the treatment arm
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Experimental: Phase 1b: BGB-A445 + Tislelizumab and Chemotherapy Combination Therapy
Dose Expansion Part B: Participants will receive recommended dose IV infusion of BGB-A445 plus 200mg tislelizumab and chemotherapy
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Administered as specified in the treatment arm
Administered as specified in the treatment arm
Other Names:
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Experimental: Phase 1b: BGB-A445 Monotherapy
Dose Expansion Part C: Participants will receive 1 dose level of BGB-A445
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Administered as specified in the treatment arm
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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
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Up to 90 days after the last dose of study drug(s) regardless of whether the participant starts a subsequent anticancer therapy
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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
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Up to 90 days after the last dose of study drug(s) regardless of whether the participant starts a subsequent anticancer therapy
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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
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Up to 90 days after the last dose of study drug(s) regardless of whether the participant starts a subsequent anticancer therapy
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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
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The MTD is defined as the highest dose evaluated for which the estimated toxicity rate is closest to the target toxicity rate of 30%
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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
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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
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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
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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
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ORR is defined as the proportion of participants who had confirmed complete response Complete Response (CR) or Partial Response (PR)
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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
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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
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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
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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
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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
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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
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Phase 1a: Serum Concentration of BGB-A445
Time Frame: 60 minutes predose up to 72 hours postdose
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60 minutes predose up to 72 hours postdose
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Phase 1a: Serum Concentration of tislelizumab
Time Frame: 60 minutes predose up to 72 hours postdose
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60 minutes predose up to 72 hours postdose
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Phase 1a: Maximum Observed Plasma Concentration (Cmax) of BGB-A445
Time Frame: 60 minutes predose up to 72 hours postdose
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60 minutes predose up to 72 hours postdose
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Phase 1a: Maximum Observed Plasma Concentration (Cmax) of tislelizumab
Time Frame: 60 minutes predose up to 72 hours postdose
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60 minutes predose up to 72 hours postdose
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Phase 1a: Minimum Observed Plasma Concentration (Cmin) of BGB-A445
Time Frame: 60 minutes predose up to 72 hours postdose
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60 minutes predose up to 72 hours postdose
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Phase 1a: Minimum Observed Plasma Concentration (Cmin) of tislelizumab
Time Frame: 60 minutes predose up to 72 hours postdose
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60 minutes predose up to 72 hours postdose
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Phase 1a: Time to Maximum Plasma Concentration (Tmax) of BGB-A445
Time Frame: 60 minutes predose up to 72 hours postdose
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60 minutes predose up to 72 hours postdose
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Phase 1a: Time to Maximum Plasma Concentration (Tmax) of tislelizumab
Time Frame: 60 minutes predose up to 72 hours postdose
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60 minutes predose up to 72 hours postdose
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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
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60 minutes predose up to 21 days postdose
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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
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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
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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
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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
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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
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Determined from investigator derived tumor assessments as per RECIST 1.1
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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
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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
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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
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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
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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
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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
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Up to 90 days after the last dose of study drug(s) regardless of whether the participant starts a subsequent anticancer therapy
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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
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Up to 90 days after the last dose of study drug(s) regardless of whether the participant starts a subsequent anticancer therapy
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Phase 1b: Serum Concentration of BGB-A445
Time Frame: 60 minutes predose up to 72 hours postdose
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60 minutes predose up to 72 hours postdose
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Phase 1b: Maximum Observed Plasma Concentration (Cmax) of BGB-A445
Time Frame: 60 minutes predose up to 72 hours postdose
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60 minutes predose up to 72 hours postdose
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Phase 1b: Minimum Observed Plasma Concentration (Cmin) of BGB-A445
Time Frame: 60 minutes predose up to 72 hours postdose
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60 minutes predose up to 72 hours postdose
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Phase 1b: Time to Maximum Plasma Concentration (Tmax) of BGB-A445
Time Frame: 60 minutes predose up to 72 hours postdose
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60 minutes predose up to 72 hours postdose
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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
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60 minutes predose up to 21 days postdose
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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
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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
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Study Director, BeiGene
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Pharyngeal Neoplasms
- Otorhinolaryngologic Neoplasms
- Head and Neck Neoplasms
- Nasopharyngeal Diseases
- Pharyngeal Diseases
- Stomatognathic Diseases
- Otorhinolaryngologic Diseases
- Nasopharyngeal Neoplasms
- Carcinoma, Squamous Cell
- Carcinoma
- Nasopharyngeal Carcinoma
- Squamous Cell Carcinoma of Head and Neck
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Tislelizumab
Other Study ID Numbers
- BGB-A317-A445-101
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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