Study of Ociperlimab (BGB-A1217) in Combination With Tislelizumab in Advanced Solid Tumors
NCT ID: NCT04047862
Last Updated: 2025-08-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
446 participants
INTERVENTIONAL
2019-08-15
2024-08-07
Brief Summary
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Primary objective of Phase 1b was to assess overall response rate (ORR) determined by Investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version (v).1.1 for patients in each dose-expansion cohort.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg
Participants received ociperlimab 50 milligrams (mg) intravenous (IV) infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (that is, \[i.e.\], every 3 weeks \[Q3W\]) until disease progression, adverse events (AEs), participant withdrew consent, lost to follow-up or death, whichever came first.
Ociperlimab
Administered as an intravenous (IV) injection
Tislelizumab
Administered as an IV injection
Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg
Participants received ociperlimab 150 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
Ociperlimab
Administered as an intravenous (IV) injection
Tislelizumab
Administered as an IV injection
Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg
Participants received ociperlimab 450 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
Ociperlimab
Administered as an intravenous (IV) injection
Tislelizumab
Administered as an IV injection
Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg
Participants received ociperlimab 900 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
Ociperlimab
Administered as an intravenous (IV) injection
Tislelizumab
Administered as an IV injection
Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg
Participants received ociperlimab 1800 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
Ociperlimab
Administered as an intravenous (IV) injection
Tislelizumab
Administered as an IV injection
Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg)
Participants received ociperlimab 900 mg as monotherapy IV infusion on Day 1 of each 21-day treatment cycle until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
Ociperlimab
Administered as an intravenous (IV) injection
Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg)
Participants received ociperlimab 900 mg as IV infusion on Day 1 of each 21-day treatment cycle and tislelizumab 200 mg IV infusion once every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.
Ociperlimab
Administered as an intravenous (IV) injection
Tislelizumab
Administered as an IV injection
Phase 1b: Dose Expansion: Cohort 1
Participants with metastatic squamous non-small cell lung cancer (NSCLC) received treatment with ociperlimab 900 mg IV infusion along with tislelizumab 200 mg IV infusion on Day 1 of each 21-day cycle. Participants also received 4 to 6 cycles of chemotherapy with carboplatin at an area under the curve (AUC) 5 or 6 (Day 1) + paclitaxel 200 or 175 mg/m\^2 (Day 1) or nab paclitaxel 100 mg/m\^2 (Days 1, 8 and 15) Q3W p until disease progression, intolerable toxicity, or withdrawal of consent.
Ociperlimab
Administered as an intravenous (IV) injection
Tislelizumab
Administered as an IV injection
Paclitaxel
Administered in accordance with local guidelines , prescribing information/summary of product
Nab paclitaxel
Administered in accordance with local guidelines , prescribing information/summary of product
Carboplatin
Administered in accordance with local guidelines , prescribing information/summary of product
Phase 1b: Dose Expansion: Cohort 2
Participants with metastatic non-squamous NSCLC received treatment with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of each 21-day cycle. Participants also received cisplatin 75 mg/m\^2 or carboplatin (AUC 5) and pemetrexed 500 mg/m\^2 (on Day 1) Q3W for 4-6 cycles followed by ociperlimab 900 mg + tislelizumab 200 mg + pemetrexed 500 mg/m\^2 on Day 1 Q3W until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
Ociperlimab
Administered as an intravenous (IV) injection
Tislelizumab
Administered as an IV injection
Pemetrexed
Administered in accordance with local guidelines, prescribing information/summary of product
Carboplatin
Administered in accordance with local guidelines , prescribing information/summary of product
Cisplatin
Administered in accordance with local guidelines , prescribing information/summary of product
Phase 1b: Dose Expansion: Cohort 3
Participants with metastatic NSCLC (programmed cell death protein-ligand 1 \[PD-L1\] positive, tumor cell \[TC\] \>=1%) were treated with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of each 21-day cycle until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
Ociperlimab
Administered as an intravenous (IV) injection
Tislelizumab
Administered as an IV injection
Phase 1b: Dose Expansion: Cohort 4
Participants with extensive-stage small-cell lung cancer (SCLC) received treatment with ociperlimab 900 mg IV infusion, tislelizumab 200 mg IV infusion. Participants also received 4 cycles of etoposide 100 mg/m\^2 (on Days 1, 2, 3), and cisplatin 75 mg/m\^2 or carboplatin AUC 5 (Day 1) Q3W, followed by ociperlimab 900 mg (Day 1) + tislelizumab 200 mg (Day 1) Q3W until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
Ociperlimab
Administered as an intravenous (IV) injection
Tislelizumab
Administered as an IV injection
Carboplatin
Administered in accordance with local guidelines , prescribing information/summary of product
Cisplatin
Administered in accordance with local guidelines , prescribing information/summary of product
Etoposide
Administered in accordance with local guidelines , prescribing information/summary of product
Phase 1b: Dose Expansion: Cohort 5
Checkpoint inhibitor (CPI)-experienced NSCLC participants received treatment with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusions on Day 1 of each 21-day cycle until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
Ociperlimab
Administered as an intravenous (IV) injection
Tislelizumab
Administered as an IV injection
Phase 1b: Dose Expansion: Cohort 6
Participants with metastatic esophageal squamous cell carcinoma (ESCC) received treatment with 6 cycles of ociperlimab 900 mg (Day 1) IV infusion, tislelizumab 200 mg (Day 1) IV infusion, cisplatin 75 mg/m\^2 (Day 1), and 5-fluorouracil 750-800 mg/m\^2 (5-FU; Day 1 to Day 5) or paclitaxel 200 or 175 mg/m\^2 (Day 1) Q3W followed by ociperlimab 900 mg and tislelizumab 200 mg on Day 1 of every 21-day cycle until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
Ociperlimab
Administered as an intravenous (IV) injection
Tislelizumab
Administered as an IV injection
Paclitaxel
Administered in accordance with local guidelines , prescribing information/summary of product
Cisplatin
Administered in accordance with local guidelines , prescribing information/summary of product
5fluorouracil
Administered in accordance with local guidelines , prescribing information/summary of product
Phase 1b: Dose Expansion: Cohort 7
Participants with metastatic esophageal adenocarcinoma (EAC) received treatment with 6 cycles of ociperlimab 900 mg (Day 1) IV infusion, tislelizumab 200 mg (Day 1) IV infusion, cisplatin 75 mg/m\^2 (Day 1), and 5-Fluorouracil 750-800 mg/m\^2 (5-FU; Day 1 to Day 5) or paclitaxel 200 or 175 mg/m\^2 (Day 1) Q3W followed by ociperlimab 900 mg and tislelizumab 200 mg on Day 1 of every 21-day cycle until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
Ociperlimab
Administered as an intravenous (IV) injection
Tislelizumab
Administered as an IV injection
Paclitaxel
Administered in accordance with local guidelines , prescribing information/summary of product
Cisplatin
Administered in accordance with local guidelines , prescribing information/summary of product
5fluorouracil
Administered in accordance with local guidelines , prescribing information/summary of product
Phase 1b: Dose Expansion: Cohort 8
Participants with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC; PD-L1 positive, visually estimated Combined Positive Score \[vCPS\] \>= 1%) received treatment with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusions on Day 1 of every 21-day cycle until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
Ociperlimab
Administered as an intravenous (IV) injection
Tislelizumab
Administered as an IV injection
Phase 1b: Dose Expansion: Cohort 9
Participants with unresectable, locally advanced, recurrent, or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma received treatment with 6 cycles of ociperlimab 900 mg (Day 1) IV infusion, tislelizumab 200 mg (Day 1) IV infusion, (oxaliplatin 1300 mg/m\^2 \[Day 1\] and capecitabine 1000 mg/m\^2 \[Day 1-14 twice daily\]), or (cisplatin 75 mg/m\^2 \[Day\], and 5-FU 750-800 mg/m\^2 \[Day 1-5\]) Q3W followed by ociperlimab 900 mg (Day 1), tislelizumab 200 mg (Day 1) + capecitabine 1000 mg/m\^2 twice daily (Day 1-14) Q3W until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
Ociperlimab
Administered as an intravenous (IV) injection
Tislelizumab
Administered as an IV injection
Cisplatin
Administered in accordance with local guidelines , prescribing information/summary of product
5fluorouracil
Administered in accordance with local guidelines , prescribing information/summary of product
Oxaliplatin
Administered in accordance with local guidelines , prescribing information/summary of product
Capecitabine
Administered in accordance with local guidelines , prescribing information/summary of product
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 450 mg + Tislelizumab 200 mg)
articipants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 450 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
Ociperlimab
Administered as an intravenous (IV) injection
Tislelizumab
Administered as an IV injection
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 900 mg + Tislelizumab 200 mg)
Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
Ociperlimab
Administered as an intravenous (IV) injection
Tislelizumab
Administered as an IV injection
Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 1800 mg + Tislelizumab 200 mg)
Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 1800 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.
Ociperlimab
Administered as an intravenous (IV) injection
Tislelizumab
Administered as an IV injection
Interventions
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Ociperlimab
Administered as an intravenous (IV) injection
Tislelizumab
Administered as an IV injection
Pemetrexed
Administered in accordance with local guidelines, prescribing information/summary of product
Paclitaxel
Administered in accordance with local guidelines , prescribing information/summary of product
Nab paclitaxel
Administered in accordance with local guidelines , prescribing information/summary of product
Carboplatin
Administered in accordance with local guidelines , prescribing information/summary of product
Cisplatin
Administered in accordance with local guidelines , prescribing information/summary of product
Etoposide
Administered in accordance with local guidelines , prescribing information/summary of product
5fluorouracil
Administered in accordance with local guidelines , prescribing information/summary of product
Oxaliplatin
Administered in accordance with local guidelines , prescribing information/summary of product
Capecitabine
Administered in accordance with local guidelines , prescribing information/summary of product
Eligibility Criteria
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Inclusion Criteria
2. Greater than or equal to (\>=) measurable lesion per RECIST v1.1.
3. Had adequate organ function.
4. Phase 1- Participants with histologically or cytologically confirmed advanced, metastatic, unresectable solid tumors who had previously received standard systemic therapy or for which treatment is not available, not tolerated or refused.
1. Signed informed consent form (ICF) and able to comply with study requirements.
2. Age \>= 18 years (or the legal age of consent) at the time the ICF was signed.
3. Histologically or cytologically confirmed tumor types in the following disease cohorts:
Cohort 1: stage IV squamous NSCLC Cohort 2: stage IV non-squamous NSCLC Cohort 3: stage IV squamous or non-squamous NSCLC with PD-L1 positive. Cohort 4: extensive-stage SCLC Cohort 5: stage IIIB, IIIC or IV NSCLC Cohort 6: stage IV ESCC Cohort 7: stage IV EAC Cohort 8: recurrent or metastatic HNSCC incurable by local therapies Cohort 9: stage IV G/GEJ adenocarcinoma. Cohort 10: stage IV squamous or non-squamous NSCLC with PD-L1 positive.
4. ECOG Performance Status \<= 1
5. Adequate organ function
6. Were willing to use highly effective method of birth control
Exclusion Criteria
2. Active autoimmune diseases or history of autoimmune diseases that could have relapsed.
3. Had severe chronic or active infections requiring systemic antibacterial, antifungal or antiviral therapy, including tuberculosis infection, etc. (antiviral therapy is permitted for patients with hepatocellular carcinoma).
4. Concurrent participation in another therapeutic clinical trial.
5. Received prior therapies targeting TIGIT.
1. Participants with any prior therapy for recurrent/metastatic disease.
2. Non-squamous NSCLC patients with sensitizing epidermal growth factor receptor (EGFR) mutation, anaplastic lymphoma kinase (ALK) fusion, and c-ros oncogene 1 (ROS1) fusion.
3. Gastric cancer participants with squamous or with positive HER2 expression.
4. Prior therapy with any drug specifically targeting T-cell co-stimulation or checkpoint pathways. (anti-PD(L)1 exception for Cohort 5).
5. Active leptomeningeal disease or uncontrolled brain metastasis.
6. Active autoimmune diseases or history of autoimmune diseases that may relapse.
7. With severe chronic or active infections requiring systemic antibacterial, antifungal or antiviral therapy, including tuberculosis infection, etc. (antiviral therapy is permitted for participants with hepatocellular carcinoma).
8. Concurrent participation in another therapeutic clinical study.
18 Years
ALL
No
Sponsors
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BeiGene
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
BeiGene
Locations
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Mayo Clinic Phoenix
Phoenix, Arizona, United States
Scri Florida Cancer Specialists South
Fort Myers, Florida, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, United States
Scri Florida Cancer Specialists North
St. Petersburg, Florida, United States
University of Kansas Medical Center Research Institute
Kansas City, Kansas, United States
University of Minnesota
Minneapolis, Minnesota, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Providence Portland Medical Center
Portland, Oregon, United States
Tennessee Oncology, Pllc Nashville
Nashville, Tennessee, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Blacktown Cancer and Haematology Centre
Blacktown, New South Wales, Australia
Chris Obrien Lifehouse
Camperdown, New South Wales, Australia
Pindara Private Hospital
Benowa, Queensland, Australia
Icon Cancer Foundation
South Brisbane, Queensland, Australia
Metro South Health, Cancer Trials Unit Division of Cancer Services Pah
Woolloongabba, Queensland, Australia
Ashford Cancer Centre Research Northeast
Windsor Gardens, South Australia, Australia
Royal Hobart Hospital
Hobart, Tasmania, Australia
Bendigo Health
Bendigo, Victoria, Australia
Monash Health
Clayton, Victoria, Australia
St Vincents Hospital
Fitzroy, Victoria, Australia
Linear Clinical Research
Nedlands, Western Australia, Australia
St John of God Health Care
Subiaco, Western Australia, Australia
The Second Hospital of Anhui Medical University
Hefei, Anhui, China
Beijing Tongren Hospital, Cmu
Beijing, Beijing Municipality, China
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Beijing Luhe Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Henan Cancer Hospital
Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Hubei Cancer Hospital
Wuhan, Hubei, China
Hunan Cancer Hospital
Changsha, Hunan, China
Jilin Cancer Hospital
Changchun, Jilin, China
The First Affiliated Hospital of Xian Jiaotong University
Xi'an, Shaanxi, China
Jinan Central Hospital
Jinan, Shandong, China
Weifang Peoples Hospital
Weifang, Shandong, China
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
Sichuan Cancer Hospital and Institute
Chengdu, Sichuan, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Auckland City Hospital
Auckland, , New Zealand
Nzcr Christchurch
Christchurch, , New Zealand
National Cancer Center
Goyang-si, Gyeonggi-do, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
The Catholic University of Korea, St Vincents Hospital
Suwon, Gyeonggi-do, South Korea
Gyeongsang National University Hospital
Jinju, Gyeongsangnam-do, South Korea
Gachon University Gil Medical Center
Incheon, Incheon Gwang'yeogsi, South Korea
Severance Hospital Yonsei University Health System
Seoul, Seoul Teugbyeolsi, South Korea
The Catholic University of Korea, Seoul St Marys Hospital
Seoul, Seoul Teugbyeolsi, South Korea
Smg Snu Boramae Medical Center
Seoul, Seoul Teugbyeolsi, South Korea
Hualien Tzu Chi Hospital
Hualien City, , Taiwan
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, , Taiwan
Chung Shan Medical University Hospital
Taichung, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
Veterans General Hospital Taichung
Taichung, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Taipei Tzu Chi Hospital
Taipei, , Taiwan
Linkou Chang Gung Memorial Hospital
Taoyuan District, , Taiwan
Countries
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References
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Frentzas S, Kao S, Gao R, Zheng H, Rizwan A, Budha N, de la Hoz Pedroza L, Tan W, Meniawy T. AdvanTIG-105: a phase I dose escalation study of the anti-TIGIT monoclonal antibody ociperlimab in combination with tislelizumab in patients with advanced solid tumors. J Immunother Cancer. 2023 Oct;11(10):e005829. doi: 10.1136/jitc-2022-005829.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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AdvanTIG-105
Identifier Type: OTHER
Identifier Source: secondary_id
CTR20202608
Identifier Type: OTHER
Identifier Source: secondary_id
BGB-900-105
Identifier Type: -
Identifier Source: org_study_id
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