Therapy Detail
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| Therapy Name | Debio 1347 |
| Synonyms | |
| Therapy Description |
Debio 1347 inhibits FGFR-1, -2, and -3, resulting in decreased downstream signaling, and potentially leading to reduced tumor cell proliferation and angiogenesis, and increased cell death in FGFR-overexpressing tumor cells (PMID: 30745300). |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Debio 1347 | CH5183284|FF284|debiopharm 1347|Zoligratinib|Debio1347|Debio-1347 | FGFR1 Inhibitor 28 FGFR2 Inhibitor 23 FGFR3 Inhibitor 19 | Debio 1347 inhibits FGFR-1, -2, and -3, resulting in decreased downstream signaling, and potentially leading to reduced tumor cell proliferation and angiogenesis, and increased cell death in FGFR-overexpressing tumor cells (PMID: 30745300). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| FGFR2 fusion FGFR2 L618V | intrahepatic cholangiocarcinoma | resistant | Debio 1347 | Preclinical - Cell culture | Actionable | In a preclinical study, Debio 1347 treatment of intrahepatic cholangiocarcinoma cells with an FGFR2 fusion in context with FGFR2 L618V were resistant to treatment, as demonstrated by cell viability and downstream signaling assays (PMID: 31109923). | 31109923 |
| FGFR3 F386L | myeloid neoplasm | sensitive | Debio 1347 | Preclinical | Actionable | In a preclinical study, Debio 1347 inhibited proliferation of myeloma cell lines harboring FGFR3 F386L in culture (PMID: 25169980). | 25169980 |
| FGFR2 fusion | Advanced Solid Tumor | predicted - sensitive | Debio 1347 | Phase I | Actionable | In a Phase I trial, Debio 1347 treatment resulted in partial response in 10.5% (6/57) and stable disease in 28.1% (16/57) of patients with advanced solid tumors harboring genomic alterations of FGFR1/2/3, including amplifications, fusions, and mutations (PMID: 30745300; NCT01948297). | 30745300 |
| FGFR3 mutant | Advanced Solid Tumor | predicted - sensitive | Debio 1347 | Phase I | Actionable | In a Phase I trial, Debio 1347 treatment resulted in partial response in 10.5% (6/57) and stable disease in 28.1% (16/57) of patients with advanced solid tumors harboring genomic alterations of FGFR1/2/3, including amplifications, fusions, and mutations (PMID: 30745300; NCT01948297). | 30745300 |
| FGFR2 I288_E295delinsT | intrahepatic cholangiocarcinoma | predicted - sensitive | Debio 1347 | Case Reports/Case Series | Actionable | In a clinical case study, Debio 1347 treatment in an intrahepatic cholangiocarcinoma patient harboring FGFR2 I288_E295delinsT led to a partial response with a 50% decrease in tumor burden, which was ongoing after 24 months (PMID: 33926920). | 33926920 |
| FGFR3 N540K | Advanced Solid Tumor | decreased response | Debio 1347 | Preclinical - Cell culture | Actionable | In a preclinical study, transformed cells over expressing FGFR3 N540K demonstrated reduced sensitivity to Debio 1347 in culture (PMID: 28034880). | 28034880 |
| FGFR2 amp | stomach carcinoma | sensitive | Debio 1347 | Preclinical - Cell line xenograft | Actionable | In a preclinical study, Debio 1347 inhibited tumor growth in cell line xenograft models of FGFR2 amplified gastric carcinoma (PMID: 26438159). | 26438159 |
| FGFR3 act mut | Advanced Solid Tumor | sensitive | Debio 1347 | Phase I | Actionable | In a Phase I trial, Debio 1347 (CH5183284) dosing regimen has been determined in solid tumor patients with activating FGFR3 alterations (JCO, Vol 33, No 15_suppl (May 20 Supplement), 2015: 2540). | detail... |
| FGFR2 N549K | endometrial cancer | sensitive | Debio 1347 | Preclinical | Actionable | In a preclinical study, Debio 1347 inhibited proliferation of endometrial cancer cells harboring FGFR2 N549K mutation in culture (PMID: 25169980). | 25169980 |
| FGFR2 amp | stomach cancer | sensitive | Debio 1347 | Preclinical - Cell line xenograft | Actionable | In a preclinical study, Debio 1347 inhibited proliferation of FGFR-amplified gastric cancer cells in culture and inhibited tumor growth in cell line xenograft models of gastric cancer harboring FGFR2 amplification (PMID: 25169980). | 25169980 |
| FGFR3 fusion | Advanced Solid Tumor | predicted - sensitive | Debio 1347 | Phase I | Actionable | In a Phase I trial, Debio 1347 treatment resulted in partial response in 10.5% (6/57) and stable disease in 28.1% (16/57) of patients with advanced solid tumors harboring genomic alterations of FGFR1/2/3, including amplifications, fusions, and mutations (PMID: 30745300; NCT01948297). | 30745300 |
| FGFR2 fusion FGFR2 N550H | intrahepatic cholangiocarcinoma | decreased response | Debio 1347 | Preclinical - Cell culture | Actionable | In a preclinical study, Debio 1347 treatment of intrahepatic cholangiocarcinoma cells with an FGFR2 fusion in context with FGFR2 N550H had weakened sensitivity, as demonstrated by cell viability and downstream signaling assays (PMID: 31109923). | 31109923 |
| FGFR3 V555M | Advanced Solid Tumor | decreased response | Debio 1347 | Preclinical - Cell culture | Actionable | In a preclinical study, transformed cells over expressing FGFR3 V555M demonstrated reduced sensitivity to Debio 1347 in culture (PMID: 28034880). | 28034880 |
| FGFR2 amp | uterine cancer | predicted - sensitive | Debio 1347 | Case Reports/Case Series | Actionable | In a Phase I trial, Debio 1347 treatment resulted in a stable disease with 3.9% change of tumor size and 60% decrease of DUSP6 score in a patient with uterine cancer harboring FGFR2 amplification (PMID: 30745300; NCT01948297). | 30745300 |
| FGFR2 H167_N173del | intrahepatic cholangiocarcinoma | predicted - sensitive | Debio 1347 | Case Reports/Case Series | Actionable | In a clinical study, Debio 1347 treatment resulted in durable partial response of 11 months in 2 patients with intrahepatic cholangiocarcinoma harboring FGFR2 H167_N173del (J Clin Oncol 38, 2020 (suppl 4; abstr 567)). | detail... |
| FGFR2 H167_N173del | intrahepatic cholangiocarcinoma | predicted - sensitive | Debio 1347 | Case Reports/Case Series | Actionable | In a Phase I trial, Debio 1347 treatment led to 51% tumor reduction and a progression-free survival of 13 months in an intrahepatic cholangiocarcinoma patient harboring FGFR2 H167_N173del, which was consistent with inhibition of growth in an intrahepatic cholangiocarcinoma cell line expressing FGFR2 H167_N173del in culture (PMID: 33926920; NCT01948297). | 33926920 |
| FGFR3 K650E | myeloid neoplasm | sensitive | Debio 1347 | Preclinical | Actionable | In a preclinical study, Debio 1347 inhibited proliferation of myeloma cell lines harboring FGFR3 K650E in culture (PMID: 25169980). | 25169980 |
| FGFR3 L608V | Advanced Solid Tumor | decreased response | Debio 1347 | Preclinical - Cell culture | Actionable | In a preclinical study, transformed cells over expressing FGFR3 L608V demonstrated reduced sensitivity to Debio 1347 in culture (PMID: 28034880). | 28034880 |
| FGFR2 fusion FGFR2 K715R | intrahepatic cholangiocarcinoma | sensitive | Debio 1347 | Preclinical - Cell culture | Actionable | In a preclinical study, Debio 1347 treatment of intrahepatic cholangiocarcinoma cells with an FGFR2 fusion in context with FGFR2 K715R were sensitive to treatment as demonstrated by decreased cell viability and decreased activation of downstream signaling, in in vitro assays (PMID: 31109923). | 31109923 |
| FGFR2 fusion FGFR2 V565F | intrahepatic cholangiocarcinoma | decreased response | Debio 1347 | Preclinical - Cell culture | Actionable | In a preclinical study, Debio 1347 treatment of intrahepatic cholangiocarcinoma cells with an FGFR2 fusion in context with FGFR2 V565F had weakened sensitivity, as demonstrated by cell viability and downstream signaling assays (PMID: 31109923). | 31109923 |
| FGFR1 fusion | Advanced Solid Tumor | predicted - sensitive | Debio 1347 | Phase I | Actionable | In a Phase I trial, Debio 1347 treatment resulted in partial response in 10.5% (6/57) and stable disease in 28.1% (16/57) of patients with advanced solid tumors harboring genomic alterations of FGFR1/2/3, including amplifications, fusions, and mutations (PMID: 30745300; NCT01948297). | 30745300 |
| FGFR3 Y373C | myeloid neoplasm | sensitive | Debio 1347 | Preclinical | Actionable | In a preclinical study, Debio 1347 inhibited proliferation of myeloma cell lines harboring FGFR3 Y373C in culture (PMID: 25169980). | 25169980 |
| FGFR2 H167_N173del | marginal zone lymphoma | predicted - sensitive | Debio 1347 | Preclinical - Cell culture | Actionable | In a clinical case study, Debio 1347 treatment in a marginal zone lymphoma patient harboring FGFR2 H167_N173del, who had previously been treated with several lines of therapy, led to a partial response and 36% decrease in tumor burden associated with lymphadenopathy and lung and liver lesions at 16 weeks, with continued response after 7 months (PMID: 33926920). | 33926920 |
| FGFR2 amp | Advanced Solid Tumor | predicted - sensitive | Debio 1347 | Phase I | Actionable | In a Phase I trial, Debio 1347 treatment resulted in partial response in 10.5% (6/57) and stable disease in 28.1% (16/57) of patients with advanced solid tumors harboring genomic alterations of FGFR1/2/3, including amplifications, fusions, and mutations (PMID: 30745300; NCT01948297). | 30745300 |
| FGFR2 amp | breast cancer | sensitive | Debio 1347 | Case Reports/Case Series | Actionable | In a Phase I trial, Debio 1347 treatment resulted in a stable disease with 19.4% reduction of tumor size and 41% decrease of DUSP6 score in a patient with lung squamous cell carcinoma harboring FGFR2 amplification (PMID: 30745300; NCT01948297). | 30745300 |
| FGFR2 amp | breast cancer | sensitive | Debio 1347 | Preclinical | Actionable | In a preclinical study, Debio 1347 inhibited proliferation of breast cancer cell lines harboring FGFR2 amplification in culture (PMID: 25169980). | 25169980 |
| FGFR2 E768* | breast cancer | predicted - sensitive | Debio 1347 | Preclinical - Cell culture | Actionable | In a preclinical study, Debio 1347 inhibited growth of mouse mammary epithelial cells expressing FGFR2 E673* (corresponding to E768* in human) in culture (PMID: 35948633). | 35948633 |
| FGFR3 S249C | urinary bladder cancer | sensitive | Debio 1347 | Preclinical - Cell line xenograft | Actionable | In a preclinical study, Debio 1347 inhibited proliferation of bladder cancer cells harboring FGFR3 S249C in culture and inhibited tumor growth in FGFR3 S249C-positive bladder cancer cell line xenograft models (PMID: 25169980). | 25169980 |
| FGFR2 fusion FGFR2 M538I | intrahepatic cholangiocarcinoma | decreased response | Debio 1347 | Preclinical - Cell culture | Actionable | In a preclinical study, Debio 1347 treatment of intrahepatic cholangiocarcinoma cells with an FGFR2 fusion in context with FGFR2 M538I had weakened sensitivity, as demonstrated by cell viability and downstream signaling assays (PMID: 31109923). | 31109923 |
| FGFR2 mutant | Advanced Solid Tumor | predicted - sensitive | Debio 1347 | Phase I | Actionable | In a Phase I trial, Debio 1347 treatment resulted in partial response in 10.5% (6/57) and stable disease in 28.1% (16/57) of patients with advanced solid tumors harboring genomic alterations of FGFR1/2/3, including amplifications, fusions, and mutations (PMID: 30745300; NCT01948297). | 30745300 |
| FGFR2 act mut | Advanced Solid Tumor | sensitive | Debio 1347 | Phase I | Actionable | In a Phase I trial, Debio 1347 (CH5183284) dosing regimen has been determined in solid tumor patients with activating FGFR2 alterations (JCO, Vol 33, No 15_suppl (May 20 Supplement), 2015: 2540). | detail... |
| FGFR2 S252W | endometrial cancer | sensitive | Debio 1347 | Preclinical - Cell line xenograft | Actionable | In a preclinical study, Debio 1347 inhibited proliferation of endometrial cancer cells harboring an FGFR2 S252W mutation in culture and inhibited tumor growth in FGFR2 S252W-positive endometrial cancer cell line xenograft models (PMID: 25169980). | 25169980 |
| FGFR2 amp | colorectal cancer | sensitive | Debio 1347 | Preclinical | Actionable | In a preclinical study, Debio 1347 inhibited proliferation of colorectal cancer cell lines harboring FGFR2 amplification in culture (PMID: 25169980). | 25169980 |
| FGFR2 amp FGFR2 mut | cervical adenocarcinoma | predicted - sensitive | Debio 1347 | Case Reports/Case Series | Actionable | In a Phase I trial, Debio 1347 treatment resulted in a partial response with 50% reduction of tumor size and 56% decrease of DUSP6 score in a patient with cervical adenocarcinoma harboring FGFR2 amplification and FGFR2 mutation (PMID: 30745300; NCT01948297). | 30745300 |
| FGFR2 H167_N173del FGFR2 L617F | intrahepatic cholangiocarcinoma | predicted - resistant | Debio 1347 | Case Reports/Case Series | Actionable | In a clinical study, a patient with intrahepatic cholangiocarcinoma harboring FGFR2 H167_N173del developed resistance to Debio 1347 treatment after initial response, FGFR2 L617F was identified as an acquired mutation at disease progression (J Clin Oncol 38, 2020 (suppl 4; abstr 567)). | detail... |
| FGFR3 K650E | Advanced Solid Tumor | sensitive | Debio 1347 | Preclinical - Cell culture | Actionable | In a preclinical study, Debio 1347 inhibited proliferation of transformed cells over expressing FGFR3 K650E in culture (PMID: 28034880). | 28034880 |
| FGFR2 fusion FGFR1 amp | colon cancer | predicted - sensitive | Debio 1347 | Case Reports/Case Series | Actionable | In a Phase I trial, Debio 1347 treatment resulted in a partial response with 49.5% reduction of tumor size and 66% decrease of DUSP6 score in a patient with colon cancer harboring FGFR1 amplification and FGFR2 fusion (PMID: 30745300; NCT01948297). | 30745300 |
| FGFR2 V564F | Advanced Solid Tumor | sensitive | Debio 1347 | Preclinical - Cell line xenograft | Actionable | In a preclinical study, Debio 1347 inhibited proliferation of transformed cells over expressing FGFR2 V564F in culture and inhibited tumor growth in cell line xenograft models (PMID: 25169980). | 25169980 |
| FGFR2 fusion FGFR2 E566A | intrahepatic cholangiocarcinoma | decreased response | Debio 1347 | Preclinical - Cell culture | Actionable | In a preclinical study, Debio 1347 treatment of intrahepatic cholangiocarcinoma cells with an FGFR2 fusion in context with FGFR2 E566A had weakened sensitivity, as demonstrated by cell viability and downstream signaling assays (PMID: 31109923). | 31109923 |
| FGFR1 amp | lung small cell carcinoma | sensitive | Debio 1347 | Preclinical | Actionable | In a preclinical study, Debio 1347 inhibited proliferation of small cell lung cancer cell lines harboring FGFR1 amplification in culture (PMID: 25169980). | 25169980 |
| FGFR2 V564L | Advanced Solid Tumor | resistant | Debio 1347 | Preclinical - Cell culture | Actionable | In a preclinical study, Debio 1347 did not inhibit Fgfr2 phosphorylation in transformed cells over expressing FGFR2 V564L in culture (PMID: 25169980). | 25169980 |
| FGFR1 act mut | Advanced Solid Tumor | sensitive | Debio 1347 | Phase I | Actionable | In a Phase I trial, Debio 1347 (CH5183284) dosing regimen has been determined in solid tumor patients with activating FGFR1 alterations (JCO, Vol 33, No 15_suppl (May 20 Supplement), 2015: 2540). | detail... |
| FGFR1 V592M FGFR1 K687E | pilomyxoid astrocytoma | predicted - sensitive | Debio 1347 | Case Reports/Case Series | Actionable | In a clinical case study, Debio 1347 treatment resulted in a significant clinical improvement and sustained stable disease at 14 months with a 12.2% maximal tumor reduction in a pediatric patient with optic pathway pilomyxoid astrocytoma harboring FGFR1 V592M and FGFR1 K687E (PMID: 34250399). | 34250399 |
| FGFR1 mutant | Advanced Solid Tumor | predicted - sensitive | Debio 1347 | Phase I | Actionable | In a Phase I trial, Debio 1347 treatment resulted in partial response in 10.5% (6/57) and stable disease in 28.1% (16/57) of patients with advanced solid tumors harboring genomic alterations of FGFR1/2/3, including amplifications, fusions, and mutations (PMID: 30745300; NCT01948297). | 30745300 |
| FGFR1 amp | lung squamous cell carcinoma | predicted - sensitive | Debio 1347 | Case Reports/Case Series | Actionable | In a Phase I trial, Debio 1347 treatment resulted in a stable disease with 26.7% reduction of tumor size and 100% decrease of DUSP6 score in a patient with lung squamous cell carcinoma harboring FGFR1 amplification (PMID: 30745300; NCT01948297). | 30745300 |
| FGFR2 fusion FGFR2 N550K | intrahepatic cholangiocarcinoma | resistant | Debio 1347 | Preclinical - Cell culture | Actionable | In a preclinical study, Debio 1347 treatment of intrahepatic cholangiocarcinoma cells with an FGFR2 fusion in context with FGFR2 N550K were resistant to treatment, as demonstrated by cell viability and downstream signaling assays (PMID: 31109923). | 31109923 |
| FGFR2 fusion FGFR2 H683L | intrahepatic cholangiocarcinoma | decreased response | Debio 1347 | Preclinical - Cell culture | Actionable | In a preclinical study, Debio 1347 treatment of intrahepatic cholangiocarcinoma cells with an FGFR2 fusion in context with FGFR2 H683L had weakened sensitivity, as demonstrated by cell viability and downstream signaling assays (PMID: 31109923). | 31109923 |
| FGFR3 amp | Advanced Solid Tumor | predicted - sensitive | Debio 1347 | Phase I | Actionable | In a Phase I trial, Debio 1347 treatment resulted in partial response in 10.5% (6/57) and stable disease in 28.1% (16/57) of patients with advanced solid tumors harboring genomic alterations of FGFR1/2/3, including amplifications, fusions, and mutations (PMID: 30745300; NCT01948297). | 30745300 |
| FGFR2 fusion FGFR2 K660M | intrahepatic cholangiocarcinoma | resistant | Debio 1347 | Preclinical - Cell culture | Actionable | In a preclinical study, Debio 1347 treatment of intrahepatic cholangiocarcinoma cells with an FGFR2 fusion in context with FGFR2 K660M were resistant to treatment, as demonstrated by cell viability and downstream signaling assays (PMID: 31109923). | 31109923 |
| FGFR2 K310R FGFR2 N549K | endometrial cancer | sensitive | Debio 1347 | Preclinical | Actionable | In a preclinical study, Debio 1347 inhibited proliferation of endometrial cancer cells harboring FGFR2 K310R and FGFR2 N549K mutations in culture (PMID: 25169980). | 25169980 |
| FGFR2 V564I | Advanced Solid Tumor | resistant | Debio 1347 | Preclinical - Cell culture | Actionable | In a preclinical study, Debio 1347 did not inhibit Fgfr2 phosphorylation in transformed cells over expressing FGFR2 V564I in culture (PMID: 25169980). | 25169980 |
| FGFR2 H167_N173del FGFR2 L618F | intrahepatic cholangiocarcinoma | predicted - resistant | Debio 1347 | Case Reports/Case Series | Actionable | In a Phase I trial, an intrahepatic cholangioncarcinoma patient who progressed in Debio 1347 was found to have acquired FGFR2 L618F, and co-expression of FGFR2 H167_N173del and FGFR2 L618F an intrahepatic cholangiocarcinoma cell line led to a reduced response to Debio 1347 treatment compared to cells expressing wild-type FGFR2 in culture (PMID: 33926920). | 33926920 |
| FGFR1 V592M FGFR1 K687E | glioblastoma | predicted - sensitive | Debio 1347 | Case Reports/Case Series | Actionable | In a clinical case study, Debio 1347 treatment resulted in a near complete response with a 96.3% maximal tumor reduction after 2 months of therapy in a pediatric patient with spinal cord glioblastoma harboring FGFR1 V592M and FGFR1 K687E, and the response was maintained for 11 months (PMID: 34250399). | 34250399 |
| FGFR1 amp | lung non-small cell carcinoma | sensitive | Debio 1347 | Preclinical | Actionable | In a preclinical study, Debio 1347 inhibited proliferation of non-small cell lung cancer cell lines harboring FGFR1 amplification in culture (PMID: 25169980). | 25169980 |
| FGFR1 amp | Advanced Solid Tumor | predicted - sensitive | Debio 1347 | Phase I | Actionable | In a Phase I trial, Debio 1347 treatment resulted in partial response in 10.5% (6/57) and stable disease in 28.1% (16/57) of patients with advanced solid tumors harboring genomic alterations of FGFR1/2/3, including amplifications, fusions, and mutations (PMID: 30745300; NCT01948297). | 30745300 |
Filtering
- Case insensitive filtering will display rows if any text in any cell matches the filter term
- Use simple literal full or partial string matches
- Separate multiple filter terms with a space. Any order may be used (i. e. 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 on a longer phrase with spaces (i.e. "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
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT03834220 | Phase II | Debio 1347 | Basket Trial in Solid Tumors Harboring a Fusion of FGFR1, FGFR2 or FGFR3- (FUZE Clinical Trial) | Terminated | USA | NLD | GBR | FRA | ESP | AUT | AUS | 16 |
| NCT01948297 | Phase I | Debio 1347 | Debio 1347-101 Phase I Trial in Advanced Solid Tumours With Fibroblast Growth Factor Receptor (FGFR) Alterations | Terminated | USA | ESP | 3 |
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