Therapy Detail
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| Therapy Name | Poziotinib |
| Synonyms | |
| Therapy Description |
Poziotinib (HM781-36B) is a pan-ErbB inhibitor that inhibits EGFR (HER1), ERBB2 (HER2) and ERBB4 (HER4), thereby reducing proliferation of tumor cells that overexpress these receptors (PMID: 21306821). |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Poziotinib | HM781-36B|NOV120101 | EGFR Inhibitor (Pan) 47 HER inhibitor (Pan) 5 | Poziotinib (HM781-36B) is a pan-ErbB inhibitor that inhibits EGFR (HER1), ERBB2 (HER2) and ERBB4 (HER4), thereby reducing proliferation of tumor cells that overexpress these receptors (PMID: 21306821, PMID: 32183953). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| ERBB2 E812K | lung adenocarcinoma | predicted - sensitive | Poziotinib | Case Reports/Case Series | Actionable | In a Phase II trial, Poziotinib (HM781-36B) treatment resulted in stable disease in a patient with lung adenocarcinoma harboring ERBB2 (HER2) E812K (PMID: 30149884; NCT02979821). | 30149884 |
| ERBB2 L755S | Advanced Solid Tumor | sensitive | Poziotinib | Preclinical - Cell culture | Actionable | In a preclinical study, Poziotinib (HM781-36B) inhibited survival of transformed cells expressing ERBB2 (HER2) L755S in culture (PMID: 31588020). | 31588020 |
| ERBB2 G778_P780dup | lung non-small cell carcinoma | predicted - sensitive | Poziotinib | Phase II | Actionable | In a Phase II trial, Poziotinib (HM781-36B) treatment resulted in a confirmed objective response rate of 42% (5/12) in patients with non-small cell lung cancer harboring ERBB2 (HER2) Y772_A775dup (n=9) or ERBB2 (HER2) G778_P780dup (n=3), with a median progression-free survival of 5.6 months (PMID: 31588020; NCT03066206). | 31588020 |
| ERBB2 D769N | Advanced Solid Tumor | sensitive | Poziotinib | Preclinical - Cell culture | Actionable | In a preclinical study, Poziotinib (HM781-36B) inhibited survival of transformed cells expressing ERBB2 (HER2) D769N in culture (PMID: 31588020). | 31588020 |
| Unknown unknown | Advanced Solid Tumor | not applicable | Poziotinib | Phase I | Actionable | In a Phase I trial, Poziotinib (HM781-36B) displayed favorable pharmacokinetics in patients with advanced solid tumors (PMID: 25377158). | 25377158 |
| ERBB2 Y772_A775dup ERBB2 C805S | Advanced Solid Tumor | resistant | Poziotinib | Preclinical - Cell culture | Actionable | In a preclinical study, ERBB2 (HER2) C805S was identified as a secondary mutation in transformed cells expressing ERBB2 (HER2) Y772_A775dup (reported as A775_G776insYVMA) that acquired resistance to Poziotinib (HM781-36B) in culture (PMID: 30527195). | 30527195 |
| ERBB2 R188C | cancer | sensitive | Poziotinib | Preclinical - Cell culture | Actionable | In a preclinical study, Poziotinib (HM781-36B) inhibited growth of transformed cells expressing ERBB2 (HER2) R188C in culture (PMID: 32366937). | 32366937 |
| ERBB2 amp PIK3CA act mut | Her2-receptor positive breast cancer | decreased response | Poziotinib | Phase II | Actionable | In a Phase II trial, the presence of PIK3CA activating mutations including E542X, E545X, and H1047X correlated with shorter progression-free survival (2.66 months) compared to PIK3CA wild-type or other mutations (4.24 month, HR=1.68, p=0.033) in patients with metastatic Erbb2 (Her2)-positive (amplification or overexpression) breast cancer treated with Poziotinib (HM781-36B) (PMID: 30720867, NCT02418689). | 30720867 |
| ERBB2 over exp PIK3CA E542X | Her2-receptor positive breast cancer | decreased response | Poziotinib | Phase II | Actionable | In a Phase II trial, the presence of PIK3CA activating mutations including E542X, E545X, and H1047X correlated with shorter progression-free survival (2.66 months) compared to PIK3CA wild-type or other mutations (4.24 month, HR=1.68, p=0.033) in patients with metastatic Erbb2 (Her2)-positive (amplification or overexpression) breast cancer treated with Poziotinib (HM781-36B) (PMID: 30720867, NCT02418689). | 30720867 |
| ERBB2 amp PIK3CA H1047X | Her2-receptor positive breast cancer | decreased response | Poziotinib | Phase II | Actionable | In a Phase II trial, the presence of PIK3CA activating mutations including E542X, E545X, and H1047X correlated with shorter progression-free survival (2.66 months) compared to PIK3CA wild-type or other mutations (4.24 month, HR=1.68, p=0.033) in patients with metastatic Erbb2 (Her2)-positive (amplification or overexpression) breast cancer treated with Poziotinib (HM781-36B) (PMID: 30720867, NCT02418689). | 30720867 |
| ERBB2 Y772_A775dup | breast cancer | sensitive | Poziotinib | Preclinical - Cell culture | Actionable | In a preclinical study, Poziotinib (HM781-36B) inhibited viability of breast cancer cells expressing ERBB2 (HER2) Y772_A775dup in culture (PMID: 31588020). | 31588020 |
| ERBB2 over exp PIK3CA act mut | Her2-receptor positive breast cancer | decreased response | Poziotinib | Phase II | Actionable | In a Phase II trial, the presence of PIK3CA activating mutations including E542X, E545X, and H1047X correlated with shorter progression-free survival (2.66 months) compared to PIK3CA wild-type or other mutations (4.24 month, HR=1.68, p=0.033) in patients with metastatic Erbb2 (Her2)-positive (amplification or overexpression) breast cancer treated with Poziotinib (HM781-36B) (PMID: 30720867, NCT02418689). | 30720867 |
| ERBB2 L755S | colorectal cancer | sensitive | Poziotinib | Preclinical - Cell line xenograft | Actionable | In a preclinical study, Poziotinib (HM781-36B) inhibited viability of colorectal cancer cells harboring ERBB2 (HER2) L755S in culture, and reduced tumor size by 58% in a cell line xenograft model (PMID: 31588020). | 31588020 |
| ERBB2 Y772_A775dup | lung cancer | sensitive | Poziotinib | Preclinical | Actionable | In a preclinical study, Poziotinib (HM781-36B) induced regression of lung tumors in mouse models harboring ERBB2 (HER2) Y772_A775dup (reported as A775_G776insYVMA), with no signs of progression at 12 weeks (PMID: 29686424). | 29686424 |
| ERBB2 L755P | lung non-small cell carcinoma | predicted - sensitive | Poziotinib | Case Reports/Case Series | Actionable | In a Phase II trial, Poziotinib (HM781-36B) treatment resulted in stable disease lasted more than 7 months in a patient with non-small cell lung cancer harboring ERBB2 (HER2) L755P (PMID: 31588020; NCT03066206). | 31588020 |
| ERBB2 Y772_A775dup | lung adenocarcinoma | predicted - sensitive | Poziotinib | Case Reports/Case Series | Actionable | In a Phase II trial, Poziotinib (HM781-36B) treatment resulted in one partial response, stable disease in one patient, and progressive disease in three patients with lung adenocarcinoma harboring ERBB2 (HER2) Y772_A775dup (reported as A775_G776insYVMA) (PMID: 30149884; NCT02979821). | 30149884 |
| ERBB2 amp | Her2-receptor positive breast cancer | predicted - sensitive | Poziotinib | Phase II | Actionable | In a Phase II trial, increased copy number (CN) of ERBB2 (HER2) was associated with improved response to Poziotinib (HM781-36B) treatment in patients with Erbb2 (Her2)-positive breast cancer, with a median progression-free survival of 4.86 months in patients with CN over 8 and 2.99 months in patients with CN equal to or less than 8 (HR=0.61, p=0.037) (PMID: 30720867, NCT02418689). | 30720867 |
| ERBB2 G776delinsVC | Advanced Solid Tumor | sensitive | Poziotinib | Preclinical - Cell culture | Actionable | In a preclinical study, Poziotinib (HM781-36B) inhibited growth of a transformed cell line expressing ERBB2 (HER2) G776delinsVC in culture (PMID: 29686424). | 29686424 |
| ERBB2 G776delinsVC | Advanced Solid Tumor | sensitive | Poziotinib | Preclinical - Cell culture | Actionable | In a preclinical study, Poziotinib (HM781-36B) inhibited survival of transformed cells expressing ERBB2 (HER2) G776delinsVC in culture (PMID: 31588020). | 31588020 |
| ERBB2 Y772_A775dup | lung non-small cell carcinoma | predicted - sensitive | Poziotinib | Phase II | Actionable | In a Phase II trial, Poziotinib (HM781-36B) treatment resulted in a confirmed objective response rate of 42% (5/12) in patients with non-small cell lung cancer harboring ERBB2 (HER2) Y772_A775dup (n=9) or ERBB2 (HER2) G778_P780dup (n=3), with a median progression-free survival of 5.6 months (PMID: 31588020; NCT03066206). | 31588020 |
| ERBB2 Y772_A775dup | lung non-small cell carcinoma | predicted - sensitive | Poziotinib | Clinical Study | Actionable | In a retrospective analysis, Poziotinib (HM781-36B) treatment resulted in an objective response rate of 33% (1/3) in non-small cell lung cancer patients harboring ERBB2 (HER2) Y772_A775dup (reported as (A775_G776insYVMA) (PMID: 30527195). | 30527195 |
| ERBB2 positive | Her2-receptor positive breast cancer | predicted - sensitive | Poziotinib | Phase II | Actionable | In a Phase II trial, Poziotinib (HM781-36B) treatment resulted in a median progression-free survival of 4.04 months, and a disease control rate of 75.49% (77/102; 20 partial responses) in heavily-treated Erbb2 (Her2)-positive breast cancer patients (Ann Oncol 2017, Vol 28, Suppl 5, Abstract # 237O; NCT02418689). | detail... |
| ERBB2 L786V | Advanced Solid Tumor | sensitive | Poziotinib | Preclinical - Cell culture | Actionable | In a preclinical study, Poziotinib (HM781-36B) inhibited survival of transformed cells expressing ERBB2 (HER2) L786V in culture (PMID: 31588020). | 31588020 |
| ERBB2 V842I | Advanced Solid Tumor | sensitive | Poziotinib | Preclinical - Cell culture | Actionable | In a preclinical study, Poziotinib (HM781-36B) inhibited survival of transformed cells expressing ERBB2 (HER2) V842I in culture (PMID: 31588020). | 31588020 |
| ERBB2 L1157R | cancer | sensitive | Poziotinib | Preclinical - Cell culture | Actionable | In a preclinical study, Poziotinib (HM781-36B) inhibited growth of transformed cells expressing ERBB2 (HER2) L1157R in culture (PMID: 32366937). | 32366937 |
| ERBB2 D769H | Advanced Solid Tumor | sensitive | Poziotinib | Preclinical - Cell culture | Actionable | In a preclinical study, Poziotinib (HM781-36B) inhibited survival of transformed cells expressing ERBB2 (HER2) D769H in culture (PMID: 31588020). | 31588020 |
| ERBB2 G776delinsVC ERBB2 C805S | Advanced Solid Tumor | resistant | Poziotinib | Preclinical - Cell culture | Actionable | In a preclinical study, ERBB2 (HER2) C805S was identified as a secondary mutation in transformed cells expressing ERBB2 (HER2) G776delinsVC that acquired resistance to Poziotinib (HM781-36B) in culture (PMID: 30527195). | 30527195 |
| ERBB2 amp PIK3CA E545X | Her2-receptor positive breast cancer | decreased response | Poziotinib | Phase II | Actionable | In a Phase II trial, the presence of PIK3CA activating mutations including E542X, E545X, and H1047X correlated with shorter progression-free survival (2.66 months) compared to PIK3CA wild-type or other mutations (4.24 month, HR=1.68, p=0.033) in patients with metastatic Erbb2 (Her2)-positive (amplification or overexpression) breast cancer treated with Poziotinib (HM781-36B) (PMID: 30720867, NCT02418689). | 30720867 |
| ERBB2 V777L | Advanced Solid Tumor | sensitive | Poziotinib | Preclinical - Cell culture | Actionable | In a preclinical study, Poziotinib (HM781-36B) inhibited survival of transformed cells expressing ERBB2 (HER2) V777L in culture (PMID: 31588020). | 31588020 |
| ERBB2 D769Y | Advanced Solid Tumor | sensitive | Poziotinib | Preclinical - Cell culture | Actionable | In a preclinical study, Poziotinib (HM781-36B) inhibited survival of transformed cells expressing ERBB2 (HER2) D769Y in culture (PMID: 31588020). | 31588020 |
| ERBB2 exon 20 ins | lung non-small cell carcinoma | predicted - sensitive | Poziotinib | Clinical Study - Cohort | Actionable | In a clinical study, Poziotinib (HM781-36B) treatment resulted in an objective response rate (ORR) of 27.6% (8/29), a disease control rate of 69%, a median progression-free survival of 5.6 months, and an overall survival of 9.5 months in patients with advanced non-small cell lung cancer harboring EGFR or ERBB2 (HER2) exon 20 insertion mutations, ORR was 50% in patients harboring ERBB2 (HER2) mutations (Annals of Oncology (2020) 31 (suppl_4): S882). | detail... |
| ERBB2 exon 20 ins | lung non-small cell carcinoma | predicted - sensitive | Poziotinib | Phase II | Actionable | In a Phase II trial (ZENITH20-2), Poziotinib (HM781-36B) demonstrated a manageable safety profile, resulted in an objective response rate of 35.1% (26/74) in evaluable patients with advanced non-small cell lung cancer harboring ERBB2 (HER2) exon 20 insertion mutations, with a median duration of response of 5.1 months, a disease control rate of 70%, and a median progression-free survival of 5.5 months (Annals of Oncology (2020) 31 (suppl_4): S1188; NCT03318939). | detail... |
| ERBB2 G776delinsVC | lung non-small cell carcinoma | predicted - sensitive | Poziotinib | Clinical Study | Actionable | In a retrospective analysis, Poziotinib (HM781-36B) treatment resulted in an objective response rate of 50% (1/2) in non-small cell lung cancer patients harboring ERBB2 (HER2) G776delinsVC (PMID: 30527195). | 30527195 |
| ERBB2 G778_P780dup | lung adenocarcinoma | predicted - sensitive | Poziotinib | Case Reports/Case Series | Actionable | In a clinical case study, Poziotinib (HM781-36B) treatment resulted in stable disease lasting nine months in a metastatic lung adenocarcinoma patient harboring ERBB2 (HER2) G778_P780dup (also reported as P780_Y781insGSP) with prior disease progression following an initial partial response to Gilotrif (afatinib) (PMID: 32036069). | 32036069 |
| ERBB2 over exp PIK3CA E545X | Her2-receptor positive breast cancer | decreased response | Poziotinib | Phase II | Actionable | In a Phase II trial, the presence of PIK3CA activating mutations including E542X, E545X, and H1047X correlated with shorter progression-free survival (2.66 months) compared to PIK3CA wild-type or other mutations (4.24 month, HR=1.68, p=0.033) in patients with metastatic Erbb2 (Her2)-positive (amplification or overexpression) breast cancer treated with Poziotinib (HM781-36B) (PMID: 30720867, NCT02418689). | 30720867 |
| ERBB2 G778_S779insLPS | Advanced Solid Tumor | sensitive | Poziotinib | Preclinical - Cell culture | Actionable | In a preclinical study, Poziotinib (HM781-36B) inhibited survival of transformed cells expressing ERBB2 (HER2) G778_S779insLPS in culture (PMID: 31588020). | 31588020 |
| ERBB2 G778_P780dup | breast cancer | sensitive | Poziotinib | Preclinical - Cell culture | Actionable | In a preclinical study, Poziotinib (HM781-36B) inhibited viability of breast cancer cells expressing ERBB2 (HER2) G778_P780dup in culture (PMID: 31588020). | 31588020 |
| ERBB2 G778_P780dup | Advanced Solid Tumor | sensitive | Poziotinib | Preclinical - Cell culture | Actionable | In a preclinical study, Poziotinib (HM781-36B) inhibited growth of a transformed cell line expressing ERBB2 (HER2) G778_P780dup (reported P780insGSP) in culture (PMID: 29686424). | 29686424 |
| ERBB2 G778_P780dup | Advanced Solid Tumor | sensitive | Poziotinib | Preclinical - Cell culture | Actionable | In a preclinical study, Poziotinib (HM781-36B) inhibited survival of transformed cells expressing ERBB2 (HER2) P780_Y781insGSP in culture (PMID: 31588020). | 31588020 |
| ERBB2 amp PIK3CA E542X | Her2-receptor positive breast cancer | decreased response | Poziotinib | Phase II | Actionable | In a Phase II trial, the presence of PIK3CA activating mutations including E542X, E545X, and H1047X correlated with shorter progression-free survival (2.66 months) compared to PIK3CA wild-type or other mutations (4.24 month, HR=1.68, p=0.033) in patients with metastatic Erbb2 (Her2)-positive (amplification or overexpression) breast cancer treated with Poziotinib (HM781-36B) (PMID: 30720867, NCT02418689). | 30720867 |
| ERBB2 G776delinsLC | Advanced Solid Tumor | sensitive | Poziotinib | Preclinical - Cell culture | Actionable | In a preclinical study, Poziotinib (HM781-36B) inhibited survival of transformed cells expressing ERBB2 (HER2) G776delinsLC in culture (PMID: 31588020). | 31588020 |
| ERBB2 G776delinsVV | Advanced Solid Tumor | sensitive | Poziotinib | Preclinical - Cell culture | Actionable | In a preclinical study, Poziotinib (HM781-36B) inhibited survival of transformed cells expressing ERBB2 (HER2) G776delinsVV in culture (PMID: 31588020). | 31588020 |
| ERBB2 G776delinsVV | Advanced Solid Tumor | sensitive | Poziotinib | Preclinical - Cell culture | Actionable | In a preclinical study, Poziotinib (HM781-36B) inhibited growth of a transformed cell line expressing ERBB2 (HER2) G776delinsVV in culture (PMID: 29686424). | 29686424 |
| ERBB2 over exp PIK3CA H1047X | Her2-receptor positive breast cancer | decreased response | Poziotinib | Phase II | Actionable | In a Phase II trial, the presence of PIK3CA activating mutations including E542X, E545X, and H1047X correlated with shorter progression-free survival (2.66 months) compared to PIK3CA wild-type or other mutations (4.24 month, HR=1.68, p=0.033) in patients with metastatic Erbb2 (Her2)-positive (amplification or overexpression) breast cancer treated with Poziotinib (HM781-36B) (PMID: 30720867, NCT02418689). | 30720867 |
| ERBB2 L869R | Advanced Solid Tumor | sensitive | Poziotinib | Preclinical - Cell culture | Actionable | In a preclinical study, Poziotinib (HM781-36B) inhibited survival of transformed cells expressing ERBB2 (HER2) L755S in culture (PMID: 31588020). | 31588020 |
| ERBB2 G776delinsVC | breast cancer | sensitive | Poziotinib | Preclinical - Cell culture | Actionable | In a preclinical study, Poziotinib (HM781-36B) inhibited Erbb2 (Her2) phosphorylation and viability of breast cancer cells expressing ERBB2 (HER2) G776delinsVC in culture (PMID: 31588020). | 31588020 |
| ERBB2 P489L | cancer | sensitive | Poziotinib | Preclinical - Cell culture | Actionable | In a preclinical study, Poziotinib (HM781-36B) inhibited growth of transformed cells expressing ERBB2 (HER2) P489L in culture (PMID: 32366937). | 32366937 |
| ERBB2 amp | stomach cancer | sensitive | Poziotinib | Preclinical | Actionable | In a preclinical study, Poziotinib suppressed cell growth, decreased phosphorylation of downstream signaling molecules, and induced apoptosis of human gastric cancer cells harboring ERBB2 (HER2) amplification (PMID: 21306821). | 21306821 |
| ERBB2 Y772_A775dup | Advanced Solid Tumor | sensitive | Poziotinib | Preclinical - Cell culture | Actionable | In a preclinical study, Poziotinib (HM781-36B) inhibited ERBB2 (HER2) phosphorylation and growth of a transformed cell line expressing ERBB2 (HER2) Y772_A775dup (reported as A775_G776insYVMA) in culture (PMID: 29686424). | 29686424 |
| ERBB2 Y772_A775dup | Advanced Solid Tumor | sensitive | Poziotinib | Preclinical - Cell culture | Actionable | In a preclinical study, Poziotinib (HM781-36B) inhibited survival of transformed cells expressing ERBB2 (HER2) Y772_A775dup in culture (PMID: 31588020). | 31588020 |
| ERBB2 G776delinsVC | lung adenocarcinoma | predicted - sensitive | Poziotinib | Case Reports/Case Series | Actionable | In a Phase II trial, Poziotinib (HM781-36B) treatment resulted in a partial response in one patient and stable disease in another patient with lung adenocarcinoma harboring ERBB2 (HER2) G776delinsVC (PMID: 30149884; NCT02979821). | 30149884 |
| ERBB2 amp PIK3CA wild-type | Her2-receptor positive breast cancer | predicted - sensitive | Poziotinib | Phase II | Actionable | In a Phase II trial, the presence of high ERBB2 (HER2) copy number and wild-type PIK3CA correlated with improved progression-free survival (HR=0.45, p=0.024) in patients with metastatic Erbb2 (Her2)-positive (amplification or overexpression) breast cancer treated with Poziotinib (HM781-36B) (PMID: 30720867, NCT02418689). | 30720867 |
| ERBB2 V773M | Advanced Solid Tumor | sensitive | Poziotinib | Preclinical - Cell culture | Actionable | In a preclinical study, Poziotinib (HM781-36B) inhibited survival of transformed cells expressing ERBB2 (HER2) V773M in culture (PMID: 31588020). | 31588020 |
| ERBB2 L755P | Advanced Solid Tumor | sensitive | Poziotinib | Preclinical - Cell culture | Actionable | In a preclinical study, Poziotinib (HM781-36B) inhibited survival of transformed cells expressing ERBB2 (HER2) L755P in culture (PMID: 31588020). | 31588020 |
Filtering
- Case insensitive filtering will display rows where any text in any cell matches the filter term
- Simple literal full or partial string matches
- Separate multiple filter terms with a spaces, order doesn't matter (a b c and c b a are equivalent )
- Filtering will only apply to rows that are already loaded on the page, filtering has no impact on query parameters
- Use quotes to match a longer phrase which contains spaces "mtor c1483f"
Sorting
- Generally, the default sort order for tables is set to be first column ascending, however, specific tables may set a different default sort order.
- Click on any column header arrows to sort by that column
- Hold down the Shift key and click multiple columns to sort by more than one column, be sure to set ascending or descending order for a given column, before moving on to the next column.
| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT03744715 | Phase II | Poziotinib | A Study to Allow Continued Treatment of Patients Who Have Participated in a Spectrum-Sponsored Poziotinib Study | Recruiting | USA | 0 |
| NCT04172597 | Phase II | Poziotinib | A Study of Poziotinib in Patients With EGFR or HER2 Activating Mutations in Advanced Malignancies | Recruiting | USA | 0 |
| NCT03318939 | Phase II | Poziotinib | Phase 2 Study of Poziotinib in Patients With NSCLC Having EGFR or HER2 Exon 20 Insertion Mutation | Recruiting | USA | CAN | 6 |
| NCT03066206 | Phase II | Poziotinib | Poziotinib in EGFR Exon 20 Mutant Advanced NSCLC | Recruiting | USA | 0 |
| NCT03804515 | Phase I | Poziotinib | A Mass Balance and Pharmacokinetics Study of 14C-Labeled Poziotinib in Cancer Patients Suitable for Treatment With Poziotinib | Active, not recruiting | USA | 0 |
| NCT02659514 | Phase II | Poziotinib | Study of Poziotinib in Patients With HER2-Positive Metastatic Breast Cancer | Active, not recruiting | USA | 0 |
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