^
7ms
A Study of ERAS-601 in People With Chordoma (clinicaltrials.gov)
P1/2, N=10, Recruiting, Memorial Sloan Kettering Cancer Center
New P1/2 trial
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ERAS-601
10ms
FLAGSHP-1: A Dose Escalation/Expansion Study of ERAS-601 in Patients With Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
P1, N=200, Active, not recruiting, Erasca, Inc. | Trial completion date: Jul 2025 --> Feb 2026 | Trial primary completion date: May 2025 --> Nov 2025
Trial completion date • Trial primary completion date
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Keytruda (pembrolizumab) • Erbitux (cetuximab) • ERAS-601
over1year
FLAGSHP-1: A Dose Escalation/Expansion Study of ERAS-601 in Patients With Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
P1, N=200, Active, not recruiting, Erasca, Inc. | Trial completion date: May 2024 --> Jul 2025 | Trial primary completion date: May 2024 --> May 2025
Trial completion date • Trial primary completion date • Combination therapy • Metastases
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Keytruda (pembrolizumab) • Erbitux (cetuximab) • ERAS-601
over1year
HERKULES-1: A Study of ERAS-007 as Monotherapy or in Combination With ERAS-601 in Patients With Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
P1/2, N=200, Active, not recruiting, Erasca, Inc. | Phase classification: P1b/2 --> P1/2 | Trial completion date: Nov 2024 --> Nov 2025 | Trial primary completion date: May 2024 --> May 2025
Phase classification • Trial completion date • Trial primary completion date • Combination therapy • Metastases
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ERAS-007 • ERAS-601
2years
FLAGSHP-1: A Dose Escalation/Expansion Study of ERAS-601 in Patients With Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
P1, N=200, Active, not recruiting, Erasca, Inc. | Recruiting --> Active, not recruiting
Enrollment closed
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Keytruda (pembrolizumab) • Erbitux (cetuximab) • ERAS-601
over2years
HERKULES-2: A Study of Anti-Cancer Therapies Targeting the MAPK Pathway in Patients With Advanced NSCLC (clinicaltrials.gov)
P1b, N=24, Completed, Erasca, Inc. | Active, not recruiting --> Completed | N=200 --> 24 | Trial completion date: Mar 2024 --> Apr 2023
Trial completion • Enrollment change • Trial completion date • Metastases
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KRAS (KRAS proto-oncogene GTPase)
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KRAS mutation • EGFR mutation • KRAS G12C
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Tagrisso (osimertinib) • Lumakras (sotorasib) • ERAS-007 • ERAS-601
over2years
Enrollment closed • Combination therapy • Metastases
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ERAS-007 • ERAS-601
almost3years
HERKULES-2: A Study of Anti-Cancer Therapies Targeting the MAPK Pathway in Patients With Advanced NSCLC (clinicaltrials.gov)
P1b, N=200, Active, not recruiting, Erasca, Inc. | Recruiting --> Active, not recruiting | Phase classification: P1b/2 --> P1b
Enrollment closed • Phase classification • Metastases
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KRAS (KRAS proto-oncogene GTPase)
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KRAS mutation • EGFR mutation • KRAS G12C
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Tagrisso (osimertinib) • Lumakras (sotorasib) • ERAS-007 • ERAS-601
over3years
Enrollment change • Trial withdrawal
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FLT3 (Fms-related tyrosine kinase 3)
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FLT3 mutation
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Xospata (gilteritinib) • ERAS-007 • ERAS-601
over3years
ERAS-601, a potent inhibitor of SHP2, synergistically enhances the activity of a FLT3 inhibitor, gilteritinib, in FLT3-mutated AML tumor models (AACR 2022)
The combination of ERAS-601 with gilteritinib achieves a more durable tumor growth inhibition than the respective gilteritinib and ERAS-601 monotherapies in vivo. These preclinical data support the clinical development of ERAS-601 in combination with gilteritinib in FLT3-altered AML.
Preclinical
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KRAS (KRAS proto-oncogene GTPase) • FLT3 (Fms-related tyrosine kinase 3) • PTPN11 (Protein Tyrosine Phosphatase Non-Receptor Type 11)
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FLT3 mutation
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Xospata (gilteritinib) • ERAS-601
over3years
ERAS-601, a potent allosteric inhibitor of SHP2, demonstrates anti-tumor activity in RAS/MAPK-driven tumor models (AACR 2022)
ERAS-601 also inhibits tumor growth in multiple RAS/MAPK-driven CDX and PDX models that harbor EGFR, KRAS, BRAF Class III, and NF1LOF mutations. ERAS-601 is a potent and selective allosteric SHP2 inhibitor that demonstrates anti-tumor activity in vitro and in vivo and is currently being studied as a monotherapy in an ongoing Phase 1 clinical study in patients with advanced or metastatic solid tumors (FLAGSHP-1, NCT04670679).
Preclinical
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EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • PTPN11 (Protein Tyrosine Phosphatase Non-Receptor Type 11) • DUSP6 (Dual specificity phosphatase 6)
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EGFR mutation • BRAF mutation • NF1 mutation
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ERAS-601
over3years
ERAS-007 (ERK inhibitor) + ERAS-601 (SHP2 inhibitor) exhibit nonclinical combination activity across KRAS mutated NSCLC, CRC, and PDAC tumor models (AACR 2022)
In KRAS mutant CDX and PDX models, this MAPKlamp’s in vitro activity was observed in vivo where it achieved superior tumor growth inhibition and tumor regression relative to ERAS-601 and ERAS-007 monotherapy. This MAPKlamp showed in vitro and in vivo combination activity in KRAS mutant tumors, and these results support its clinical evaluation in RAS/MAPK pathway-driven tumors.
Preclinical
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EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene)
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KRAS mutation • BRAF mutation
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ERAS-007 • ERAS-601