Therapy Detail
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| Therapy Name | RLY-4008 |
| Synonyms | |
| Therapy Description |
RLY-4008 binds to and inhibits FGFR2, selectively targeting primary oncogenic FGFR2 mutations and leads to decreased FGFR2-dependent signaling, potentially resulting in inhibition of tumor cell proliferation (NCI Drug Dictionary; Journal of Clinical Oncology 39, no. 15_suppl). |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| RLY-4008 | RLY4008|RLY 4008|Lirafugratinib | FGFR2 Inhibitor 21 | RLY-4008 binds to and inhibits FGFR2, selectively targeting primary oncogenic FGFR2 mutations and leads to decreased FGFR2-dependent signaling, potentially resulting in inhibition of tumor cell proliferation (NCI Drug Dictionary; Journal of Clinical Oncology 39, no. 15_suppl). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| FGFR2 fusion | stomach cancer | predicted - sensitive | RLY-4008 | Preclinical - Cell line xenograft | Actionable | In a preclinical study, RLY-4008 treatment led to tumor regression in a cell line xenograft model of gastric cancer harboring an FGFR2 fusion (Cancer Res 2021;81(13_Suppl):Abstract nr 1455). | detail... |
| FGFR2 amp | stomach cancer | predicted - sensitive | RLY-4008 | Preclinical - Cell line xenograft | Actionable | In a preclinical study, RLY-4008 treatment led to tumor regression in a cell line xenograft model of gastric cancer harboring an FGFR2 amplification (Cancer Res 2021;81(13_Suppl):Abstract nr 1455). | detail... |
| FGFR2 fusion | lung cancer | predicted - sensitive | RLY-4008 | Preclinical - Cell line xenograft | Actionable | In a preclinical study, RLY-4008 treatment led to tumor regression in a cell line xenograft model of lung cancer harboring an FGFR2 fusion (Cancer Res 2021;81(13_Suppl):Abstract nr 1455). | detail... |
| FGFR2 N549K | endometrial cancer | predicted - sensitive | RLY-4008 | Preclinical - Cell culture | Actionable | In a preclinical study, RLY-4008 treatment led to tumor regression in a cell line xenograft model of endometrial cancer harboring FGFR2 N549K (Cancer Res 2021;81(13_Suppl):Abstract nr 1455). | detail... |
| FGFR2 fusion FGFR2 V564F | intrahepatic cholangiocarcinoma | predicted - sensitive | RLY-4008 | Preclinical - Cell line xenograft | Actionable | In a preclinical study, RLY-4008 treatment led to tumor regression in a cell line xenograft model of intrahepatic cholangiocarcinoma harboring an FGFR2 fusion and FGFR2 V564F (Cancer Res 2021;81(13_Suppl):Abstract nr 1455). | detail... |
| FGFR2 fusion | cholangiocarcinoma | predicted - sensitive | RLY-4008 | Phase Ib/II | Actionable | In a Phase I/II trial (ReFocus), RLY-4008 treatment resulted in an objective response rate (ORR) of 88% (15/17), a confirmed ORR of 82.4% (14/17), and a disease control rate of 100% (17/17) at the recommended Phase II dose, and an ORR of 63.2% (24/38) at all dose levels in patients with FGFR inhibitor-naive cholangiocarcinoma harboring FGFR2 fusions or rearrangements (Ann Oncol (2022) 33 (suppl_7): S808-S869; NCT04526106). | detail... |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT04526106 | Phase I | RLY-4008 | First-in-human Study of Highly Selective FGFR2 Inhibitor, RLY-4008, in Patients With ICC and Other Advanced Solid Tumors | Recruiting | USA | ITA | FRA | ESP | DEU | 8 |
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