Tiragolumab

Phase 3Monoclonal antibody

Tiragolumab is being investigated as a cancer treatment that works by helping the immune system recognize and attack cancer cells more effectively.[1] Tiragolumab is currently being investigated across 19 indications[3], with its most advanced program in Phase 3.[1]

Tiragolumab is one of 412 small molecule programs targeting Squamous Cell Carcinoma. It is currently in Phase 3.

Indications

Total Trials

Active Trials

411

Competitors

Pipeline

Status by Indication[3][1]

Indication

Squamous Cell CarcinomaActive, not recruiting

MelanomaActive, not recruiting

Atypical Teratoid/rhabdoid TumorActive, not recruiting

Clinical Stage II Esophageal Adenocarcinoma AJCC V8Active, not recruiting

Rectal NeoplasmsActive, not recruiting

Urothelial CancerActive, not recruiting

ImmunotherapyActive, not recruiting

AdvancedRecruiting

Advanced Solid MalignanciesActive, not recruiting

Hepatocellular CarcinomaActive, not recruiting

Squamous Cell CarcinomaPhase 2

Active, not recruiting

MelanomaPhase 2

Active, not recruiting

Atypical Teratoid/rhabdoid TumorPreclinical

Active, not recruiting

Clinical Stage II Esophageal Adenocarcinoma AJCC V8Phase 2

Active, not recruiting

Rectal NeoplasmsPhase 2

Active, not recruiting

Urothelial CancerPhase 2

Active, not recruiting

ImmunotherapyPhase 2

Active, not recruiting

AdvancedPhase 2

Recruiting

Advanced Solid MalignanciesPhase 1

Active, not recruiting

Hepatocellular CarcinomaPhase 3

Active, not recruiting

Showing 10 of 19 indications

Competition

Competitive Landscape

744 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Tiragolumab

Roche

Phase 3

1 2

Lexiscan

Astellas

Preclinical

1 3

Sporanox

SSebela Pharmaceuticals Development LLC

Preclinical

1 4

Tianeptine

Pfizer

Preclinical

1 5

Diuretic

RReprieve Cardiovascular, Inc

Preclinical

1 6

Recombinant Human Endostatin

PPeking University Third Hospital

Preclinical

1 7

Naltrexone/bupropion

Novo Nordisk

Preclinical

1 8

Motexafin Gadolinium

PPharmacyclics LLC.

Preclinical

1 9

Perflutren Lipid Microsphere

IImaRx Therapeutics

Preclinical

1 10

Sertraline ODT

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Active, not recruiting

Renal Cell Carcinoma

NCT05805501

Phase 2Recruiting

Squamous Cell Carcinoma

NCT05681039

Phase 2Active, not recruiting

Immunotherapy

NCT05798663

Phase 2Active, not recruiting

Rectal Neoplasms

NCT05009069

Phase 2Active, not recruiting

Advanced Stage

NCT05715281

Phase 2Active, not recruiting

Urothelial Cancer

NCT05645692

Clinical

Trials by Indication[1]

Non-Small Cell Lung Cancer9 trials

A Study of Tiragolumab Plus Atezolizumab Compared With Placebo Plus Atezolizumab in Participants With Completely Resected Non-small Cell Lung Cancer Who Have Received Adjuvant Platinum-based Chemotherapy

Completed· Roche logo

Roche·Phase 3·NCT06267001·56 enrolled

A Study Of Multiple Immunotherapy-Based Treatment Combinations In Participants With Metastatic Non-Small Cell Lung Cancer (Morpheus- Non-Small Cell Lung Cancer)

Completed· Roche logo

Roche·Phase 1/2·NCT03337698·314 enrolled

A Study of Tiragolumab in Combination With Atezolizumab in Chemotherapy-Naïve Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Completed· Roche logo

Roche·Phase 2·NCT03563716·135 enrolled

Show 6 more trials

A Study Evaluating the Safety and Efficacy of Neoadjuvant and Adjuvant Tiragolumab Plus Atezolizumab, With or Without Platinum-Based Chemotherapy, in Participants With Previously Untreated Locally Advanced Resectable Stage II, IIIA, or Select IIIB Non-Small Cell Lung Cancer

Terminated· Roche logo

Roche·Phase 2·NCT04832854·50 enrolled

A Study of Atezolizumab and Tiragolumab Compared With Durvalumab in Participants With Locally Advanced, Unresectable Stage III Non-Small Cell Lung Cancer (NSCLC)

Completed· Roche logo

Roche·Phase 3·NCT04513925·829 enrolled

A Study of Tiragolumab in Combination With Atezolizumab Plus Pemetrexed and Carboplatin/Cisplatin Versus Pembrolizumab Plus Pemetrexed and Carboplatin/Cisplatin in Participants With Previously Untreated Advanced Non-Squamous Non-Small Cell Lung Cancer

Completed· Roche logo

Roche·Phase 2/3·NCT04619797·542 enrolled

Tiragolumab and Atezolizumab in Patients With Non-squamous Non-small Cell Lung Cancer (NSCLC) and Untreated Brain Metastases

Terminated·LLiza Villaruz, MD·Phase 2·NCT05746481·3 enrolled

Neoadjuvant TiRagolumab, Atezolizumab and Chemotherapy - Dissection of IO Efficacy in NSCLC by Longitudinal tracKing: a Non-randomized, Open-label, Single-arm Phase II Study

Active, not recruiting·IInstitut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest·Phase 2·NCT05825625·35 enrolled

SKYSCRAPER-01: Atezolizumab + Tiragolumab in NSCLC

Active, not recruiting· Roche logo

Roche·Phase 3·NCT04294810·800 enrolled

Squamous Cell Carcinoma5 trials

A Study Evaluating Efficacy and Safety of Multiple Treatment Combinations in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck (Morpheus-Head and Neck Cancer)

Completed· Roche logo

Roche·Phase 1/2·NCT05459129·12 enrolled

Phase 2 Trial of Neoadjuvant and Adjuvant Tiragolumab Plus Atezolizumab in Patients With Newly Diagnosed PD-L1 CPS Positive Resectable Stage 3-4 Oral Cavity Squamous Cell Carcinoma (OCSCC).

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT05681039·29 enrolled

A Study of Atezolizumab Plus Tiragolumab and Atezolizumab Plus Placebo as First-Line Treatment in Participants With Recurrent/Metastatic PD-L1 Positive Squamous Cell Carcinoma of the Head and Neck

Completed· Roche logo

Roche·Phase 2·NCT04665843·123 enrolled

Show 2 more trials

STRIVE: A Single-arm Phase 2 Study on Treatment of Lung Squamous Cell Carcinoma by Tiragolumab Plus Ivonescimab for Patients Who Progressed on Platinum Doublets and Anti-PD-1/PD-L1

Withdrawn·MM.D. Anderson Cancer Center·Phase 2·NCT07038915

A Phase II Study of Preoperative Immunotherapy in Patients With Squamous Cell Carcinoma of the Head and Neck

Active, not recruiting·AAlain Algazi·Phase 2·NCT03708224·55 enrolled

Metastatic Colorectal Cancer3 trials

Trial of Atezolizumab, Bevacizumab, and Tiragolumab in Patients With Microsatellite Stable, Metastatic Colorectal Cancer

Active, not recruiting·UUniversity of Colorado, Denver·Phase 2·NCT06784947·13 enrolled

Immunotherapies in Combination With Stereotactic Body Radiation Radiotherapy in Microsatellite Stable (MSS) Metastatic Colorectal Cancer (mCRC)

Withdrawn·NNational Cancer Institute (NCI)·Phase 2·NCT06603818

A Phase I/Ib Global, Multicenter, Open-label Umbrella Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic Colorectal Cancer (INTRINSIC)

Recruiting· Roche logo

Roche·Phase 1·NCT04929223·542 enrolled

Melanoma3 trials

A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Melanoma (Morpheus-Melanoma)

Completed· Roche logo

Roche·Phase 1/2·NCT05116202·110 enrolled

Vemurafenib, Cobimetinib, Atezolizumab, and Tiragolumab in Treating Patients With High-Risk Stage III Melanoma

Active, not recruiting·MMayo Clinic·Phase 2·NCT03554083·59 enrolled

Tiragolumab Plus Atezolizumab Versus Atezolizumab in the Treatment of Stage II Melanoma Patients Who Are ctDNA-positive Following Resection

Terminated·WWashington University School of Medicine·Phase 2·NCT05060003·7 enrolled

Advanced Solid Tumors2 trials

A Study Evaluating Targeted Therapies in Participants Who Have Advanced Solid Tumors With Genomic Alterations or Protein Expression Patterns Predictive of Response

Completed· Roche logo

Roche·Phase 2·NCT04632992·252 enrolled

Atezolizumab and Tiragolumab in Patients With NSCLC or Advanced Solid Tumors Having Had Prior Treatment With a PD-1 Inhibitor

Completed·SSCRI Development Innovations, LLC·Phase 2·NCT03977467·46 enrolled

36 more indications

Urothelial Carcinoma2 trials

Neoadjuvant PD-1 Plus TIGIT Blockade in Patients With Cisplatin-Ineligible Operable High-Risk Urothelial Carcinoma

Recruiting·MM.D. Anderson Cancer Center·Phase 1/2·NCT05394337·10 enrolled

A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatments and Combinations in Patients With Urothelial Carcinoma (MORPHEUS-UC)

Terminated· Roche logo

Roche·Preclinical·NCT03869190·272 enrolled

Small Cell Lung Cancer2 trials

A Study of Atezolizumab With or Without Tiragolumab Consolidation in Limited Stage Small Cell Lung Cancer

Terminated· Roche logo

Roche·Phase 2·NCT04308785·24 enrolled

A Study of Atezolizumab Plus Carboplatin and Etoposide With or Without Tiragolumab in Patients With Untreated Extensive-Stage Small Cell Lung Cancer

Completed· Roche logo

Roche·Phase 3·NCT04256421·490 enrolled

Immune Checkpoint Inhibition1 trial

A Phase 2 Clinical Trial Evaluating the Efficacy and Safety of Dual Immune Checkpoint Inhibition With Anti-PD-L1 (Atezolizumab) and Anti-TIGIT (Tiragolumab) in Cancer of Unknown Primary

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT06754501·4 enrolled

Glioblastoma1 trial

Testing the Combination of Anti-cancer Drugs Tiragolumab and Atezolizumab to Improve Outcomes for Patients With Recurrent Glioblastoma

Withdrawn·NNational Cancer Institute (NCI)·Phase 2·NCT06328036

Breast Cancer1 trial

NOvel Immunotherapy Strategies for Advanced Triple Negative Breast Cancer (TNBC) Patients: TONIC-3 Trial

Recruiting·TThe Netherlands Cancer Institute·Phase 2·NCT06342037·60 enrolled

Endometrial Cancer1 trial

A Study of Targeted Agents for Patients With Recurrent or Persistent Endometrial Cancer

Recruiting·AAlliance Foundation Trials, LLC.·Phase 1/2·NCT04486352·148 enrolled

Gastroesophageal Junction Carcinoma1 trial

An Umbrella Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Gastric or Gastroesophageal Junction Carcinoma

Completed· Roche logo

Roche·Phase 1/2·NCT05251948·40 enrolled

Recurrent or Metastatic Solid Tumors1 trial

A Study to Evaluate the Safety and Pharmacokinetics of the Intravenous Fixed-Dose Combination (IV FDC) of Tiragolumab and Atezolizumab in Participants With Locally Advanced, Recurrent or Metastatic Solid Tumors

Completed· Roche logo

Roche·Phase 2·NCT05661578·64 enrolled

Multiple Myeloma1 trial

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), and Preliminary Activity of Tiragolumab in Participants With Relapsed or Refractory Multiple Myeloma or With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

Terminated· Roche logo

Roche·Phase 1·NCT04045028·41 enrolled

Lymphoma1 trial

An Open-Label, Multicenter Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Mosunetuzumab in Combination With Tiragolumab With or Without Atezolizumab in Participants With B-Cell Non-Hodgkin Lymphoma

Terminated· Roche logo

Roche·Phase 1/2·NCT05315713·8 enrolled

Stereotactic Body Radiation Therapy1 trial

Study Evaluating the Safety and the Efficacy of Combination of Atezolizumab, Tiragolumab and and Stereotactic Body Radiation Therapy in Patients With Oligometastatic Multiorgan (IMMUNOs-SBRT)

Unknown status·CCentre Georges Francois Leclerc·Phase 1·NCT05259319·92 enrolled

Advanced1 trial

Tiragolumab and Atezolizumab in Advanced Pan-cancer Patients

Recruiting·OOmico·Phase 2·NCT06003621·96 enrolled

Adenocarcinoma1 trial

A Study to Explore the Efficacy and Safety of Atezolizumab Plus Tiragolumab and Chemotherapy in 1st Line HER2 Negative Unresectable, Recurrent or Metastatic Gastric Cancer or Adenocarcinoma of Gastroesophageal Junction (GEJ)

Terminated· Roche logo

Roche·Phase 2·NCT04933227·29 enrolled

Triple-Negative Breast Cancer1 trial

A Study of the Safety, Efficacy, and Pharmacokinetics of Tiragolumab in Combination With Atezolizumab and Chemotherapy in Participants With Triple-Negative Breast Cancer

Completed· Roche logo

Roche·Phase 1·NCT04584112·83 enrolled

Immunotherapy1 trial

Atezolizumab Immunotherapy With or Without Tiragolumab for Patients With Unresectable Stage III NSCLC

Active, not recruiting·AAlliance Foundation Trials, LLC.·Phase 2·NCT05798663·178 enrolled

Microsatellite Instability1 trial

A Study of Adjuvant Atezolizumab or Atezolizumab Plus Tiragolumab in Solid Tumors with Resectable Disease with Intermediate-High Risk of Recurrence and High Tumor Mutational Burden (TMB-H) or Microsatellite Instability (MSI-H)

Withdrawn· Roche logo

Roche·Phase 2·NCT06331598

Advanced Solid Malignancies1 trial

Phase I/Ib Trial of TIraGolumab, AtEzolizumab, and RadScopal Radiation in Patients With Advanced Solid Malignancies (TIGER)

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 1·NCT06760481·7 enrolled

Advanced Stage1 trial

Testing the Combination of Anti-cancer Drugs Atezolizumab and Tiragolumab in People With Advanced Stage Rare Cancers, RARE3 Trial

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT05715281·12 enrolled

Cervical Cancer1 trial

A Study of Tiragolumab Plus Atezolizumab and Atezolizumab Monotherapy in Participants With Metastatic and/or Recurrent PD-L1-Positive Cervical Cancer

Completed· Roche logo

Roche·Phase 2·NCT04300647·172 enrolled

Metastatic Tumors1 trial

Safety and Pharmacokinetics (PK) of Escalating Doses of Tiragolumab as a Single Agent and in Combination With Atezolizumab and/or Other Anti-Cancer Therapies in Locally Advanced or Metastatic Tumors

Completed· Roche logo

Roche·Phase 1·NCT02794571·518 enrolled

Pancreatic Ductal Adenocarcinoma1 trial

A Study of Multiple Immunotherapy-Based Treatment Combinations in Participants With Metastatic Pancreatic Ductal Adenocarcinoma (Morpheus-Pancreatic Cancer)

Completed· Roche logo

Roche·Phase 1/2·NCT03193190·341 enrolled

Hepatocellular Carcinoma1 trial

A Study Evaluating Atezolizumab and Bevacizumab, With or Without Tiragolumab, in Participants With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma (HCC) (IMbrave152)

Active, not recruiting· Roche logo

Roche·Phase 3·NCT05904886·687 enrolled

Locally Advanced1 trial

Immunotherapy With CCRT Followed by Surgery for Locally Advanced ESCC Patients

Unknown status·NNational Taiwan University Hospital·Phase 1/2·NCT05743504·32 enrolled

Small Cell Lung Carcinoma1 trial

A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Atezolizumab Plus Carboplatin and Etoposide With or Without Tiragolumab in Patients With Untreated Extensive-Stage Small Cell Lung Cancer

Completed· Roche logo

Roche·Phase 3·NCT04665856·123 enrolled

Carcinoma, Hepatocellular1 trial

A Phase Ib/II, Open-Label, Multicenter, Randomized Platform Study Evaluating The Efficacy and Safety of Neoadjuvant Immunotherapy Combinations in Patients With Surgically Resectable Hepatocellular Carcinoma (MORPHEUS-NEO HCC)

Terminated· Roche logo

Roche·Preclinical·NCT05908786·62 enrolled

Esophageal Squamous Cell Carcinoma1 trial

A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Atezolizumab With or Without Tiragolumab (Anti-TIGIT Antibody) in Patients With Unresectable Esophageal Squamous Cell Carcinoma Whose Cancers Have Not Progressed Following Definitive Concurrent Chemoradiotherapy

Completed· Roche logo

Roche·Phase 3·NCT04543617·760 enrolled

Non-Squamous Non-Small Cell Lung Cancer1 trial

A Phase II Open-label Multi-cohort Study Evaluating the Efficacy of Tiragolumab With Atezolizumab Plus Bevacizumab in Previously-Treated Advanced Non-squamous NSCLC

Active, not recruiting·GGeorgetown University·Phase 2·NCT04958811·29 enrolled

Advanced Liver Cancers1 trial

A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Advanced Liver Cancers (Morpheus-Liver)

Active, not recruiting· Roche logo

Roche·Preclinical·NCT04524871·518 enrolled

Esophageal Cancer1 trial

A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Atezolizumab Plus Tiragolumab in Combination With Paclitaxel and Cisplatin Compared With Paclitaxel and Cisplatin as First-Line Treatment in Patients With Unresectable Locally Advanced, Unresectable Recurrent, or Metastatic Esophageal Squamous Cell Carcinoma

Completed· Roche logo

Roche·Phase 3·NCT04540211·461 enrolled

Renal Cell Carcinoma1 trial

A Randomized Open Label Phase II Study of Immune Checkpoint Inhibitor Combinations With Axitinib in Patients With Previously Untreated Locally Advanced Unresectable or Metastatic Renal Cell Carcinoma

Active, not recruiting· Roche logo

Roche·Phase 2·NCT05805501·199 enrolled

Gastroesophageal Junction Adenocarcinoma1 trial

A Phase Ib/II, Open-Label, Multicenter, Randomized, Umbrella Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Cancer or Esophageal Cancer (Morpheus-Gastric and Esophageal Cancer)

Terminated· Roche logo

Roche·Preclinical·NCT03281369·219 enrolled

Urothelial Cancer1 trial

A Phase II, Randomized, Multicenter, Open-Label, Controlled Study of Tobemstomig Alone or in Combination With Tiragolumab Versus Atezolizumab in Patients With Previously Untreated Locally Advanced or Metastatic Urothelial Cancer Who Are Ineligible for Platinum-Containing Chemotherapy

Active, not recruiting· Roche logo

Roche·Phase 2·NCT05645692·204 enrolled

Rectal Neoplasms1 trial

A Phase II, Randomized, Open Label, Parallel-group Study of Atezolizumab With or Without Tiragolumab Following Neoadjuvant Chemoradiotherapy in Patients With Locally Advanced Rectal Cancer

Active, not recruiting· Roche logo

Roche·Phase 2·NCT05009069·58 enrolled

Clinical Stage II Esophageal Adenocarcinoma AJCC v81 trial

Phase I/II Study of Perioperative Chemotherapy Plus Immunotherapy Followed by Surgery in Localized Esophageal and Gastroesophageal Adenocarcinoma

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT03784326·43 enrolled

Atypical Teratoid/Rhabdoid Tumor1 trial

A Phase 1/2 Study of Tiragolumab (NSC# 827799) and Atezolizumab (NSC# 783608) in Patients With Relapsed or Refractory SMARCB1 or SMARCA4 Deficient Tumors

Active, not recruiting·NNational Cancer Institute (NCI)·Preclinical·NCT05286801·86 enrolled

Unspecified1 trial

An Open-Label, Multicenter Extension Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Study

Recruiting· Roche logo

Roche·Phase 3·NCT05862285·100 enrolled

Sources

References

[1]
ClinicalTrials.gov — 60 trial records for Tiragolumab. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Tiragolumab compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Tiragolumab. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Roche company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: T-Cell Immunoreceptor With Ig and ITIM Domains Inhibitor[2]
Modality: Monoclonal antibody[2]
Highest Phase: Phase 3[1]
Company: Roche

Tiragolumab

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Trials by Indication[1]

Non-Small Cell Lung Cancer9 trials

Squamous Cell Carcinoma5 trials

Metastatic Colorectal Cancer3 trials

Melanoma3 trials

Advanced Solid Tumors2 trials

Urothelial Carcinoma2 trials

Small Cell Lung Cancer2 trials

Immune Checkpoint Inhibition1 trial

Glioblastoma1 trial

Breast Cancer1 trial

Endometrial Cancer1 trial

Gastroesophageal Junction Carcinoma1 trial

Recurrent or Metastatic Solid Tumors1 trial

Multiple Myeloma1 trial

Lymphoma1 trial

Stereotactic Body Radiation Therapy1 trial

Advanced1 trial

Adenocarcinoma1 trial

Triple-Negative Breast Cancer1 trial

Immunotherapy1 trial

Microsatellite Instability1 trial

Advanced Solid Malignancies1 trial

Advanced Stage1 trial

Cervical Cancer1 trial

Metastatic Tumors1 trial

Pancreatic Ductal Adenocarcinoma1 trial

Hepatocellular Carcinoma1 trial

Locally Advanced1 trial

Small Cell Lung Carcinoma1 trial

Carcinoma, Hepatocellular1 trial

Esophageal Squamous Cell Carcinoma1 trial

Non-Squamous Non-Small Cell Lung Cancer1 trial

Advanced Liver Cancers1 trial

Esophageal Cancer1 trial

Renal Cell Carcinoma1 trial

Gastroesophageal Junction Adenocarcinoma1 trial

Urothelial Cancer1 trial

Rectal Neoplasms1 trial

Clinical Stage II Esophageal Adenocarcinoma AJCC v81 trial

Atypical Teratoid/Rhabdoid Tumor1 trial

Unspecified1 trial

References

Drug Info

Quick Facts

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