^
    Contact us  to learn more about
    our Premium Content:  News alerts, weekly reports and conference planners
    DRUG:

    ERAS-007

    i
    Other names: ERAS-007, ASN007, ASN007A
    Company:
    Asana BioSci, Erasca, UT MD Anderson Cancer Center
    Drug class:
    ERK2 inhibitor, ERK1 inhibitor
    Related drugs:
    10ms
    HERKULES-3: A Study of ERAS-007 in Patients With Advanced Gastrointestinal Malignancies (clinicaltrials.gov)
    P1/2, N=102, Active, not recruiting, Erasca, Inc. | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Aug 2024 --> Aug 2025
    Trial completion date • Trial primary completion date
    |
    KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • NRAS (Neuroblastoma RAS viral oncogene homolog)
    |
    BRAF V600E • KRAS mutation • NRAS mutation • BRAF V600
    |
    Erbitux (cetuximab) • Ibrance (palbociclib) • Braftovi (encorafenib) • ERAS-007
    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
    |
    ERAS-007 • ERAS-601
    almost2years
    HERKULES-3: A Study of ERAS-007 in Patients With Advanced Gastrointestinal Malignancies (clinicaltrials.gov)
    P1/2, N=102, Active, not recruiting, Erasca, Inc. | Recruiting --> Active, not recruiting | Phase classification: P1b/2 --> P1/2 | N=200 --> 102
    Enrollment closed • Phase classification • Enrollment change • Metastases
    |
    KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • NRAS (Neuroblastoma RAS viral oncogene homolog)
    |
    BRAF V600E • KRAS mutation • NRAS mutation • BRAF V600
    |
    Erbitux (cetuximab) • Ibrance (palbociclib) • Braftovi (encorafenib) • ERAS-007
    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
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • EGFR mutation • KRAS G12C
    |
    Tagrisso (osimertinib) • Lumakras (sotorasib) • ERAS-007 • ERAS-601
    over2years
    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)
    P1b/2, N=200, Active, not recruiting, Erasca, Inc. | Recruiting --> Active, not recruiting
    Enrollment closed • Combination therapy • Metastases
    |
    ERAS-007 • ERAS-601
    over2years
    Preliminary results from ERAS-007 plus palbociclib (palbo) in patients (pts) with KRAS/NRAS mutant (m) colorectal cancer (CRC) or KRASm pancreatic ductal adenocarcinoma (PDAC) in HERKULES-3 study: A phase 1b/2 study of agents targeting the mitogen-activated protein kinase (MAPK) pathway in pts with advanced gastrointestinal malignancies (GI cancers). (ASCO 2023)
    ERAS-007 in combination with palbo in pts with KRASm/NRASm CRC or KRASm PDAC shows expected preliminary safety with reversible and manageable AEs. The highest dose evaluated and cleared by the safety review committee to date is ERAS-007 100 mg BID-QW in combination with the approved monotherapy dose of palbo 125 mg QD. Clinical trial information: NCT05039177.
    Clinical • P1/2 data • Metastases
    |
    KRAS (KRAS proto-oncogene GTPase) • NRAS (Neuroblastoma RAS viral oncogene homolog)
    |
    KRAS mutation • NRAS mutation
    |
    Ibrance (palbociclib) • ERAS-007
    over2years
    Preliminary results from ERAS-007 plus encorafenib and cetuximab (EC) in patients (pts) with metastatic BRAF V600E mutated colorectal cancer (CRC) in HERKULES-3 study: A phase 1b/2 study of agents targeting the mitogen-activated protein kinase (MAPK) pathway in pts with advanced gastrointestinal malignancies (GI cancers). (ASCO 2023)
    ERAS-007+EC in pts with BRAF V600E CRC shows acceptable preliminary safety/tolerability and evidence of clinical activity. The highest dose of ERAS-007 evaluated and cleared by the safety review committee to date is 100 mg BID-QW when combined with EC. Observed PK, toxicity, and preliminary activity support continued evaluation of this combination in pts with BRAF V600E CRC.
    Clinical • P1/2 data • Metastases
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF V600E • BRAF V600
    |
    Erbitux (cetuximab) • Braftovi (encorafenib) • ERAS-007
    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
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • EGFR mutation • KRAS G12C
    |
    Tagrisso (osimertinib) • Lumakras (sotorasib) • ERAS-007 • ERAS-601
    over3years
    HERKULES-4: A Study of Anti-Cancer Therapies Targeting the MAPK Pathway in Patients With Hematologic Malignancies (clinicaltrials.gov)
    P1b/2, N=0, Withdrawn, Erasca, Inc. | N=120 --> 0 | Recruiting --> Withdrawn
    Enrollment change • Trial withdrawal
    |
    FLT3 (Fms-related tyrosine kinase 3)
    |
    FLT3 mutation
    |
    Xospata (gilteritinib) • ERAS-007 • 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
    |
    EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene)
    |
    KRAS mutation • BRAF mutation
    |
    ERAS-007 • ERAS-601
    over3years
    ­­­­ERAS-007 is a selective ERK1/2 inhibitor with preclinical activity across RAS/MAPK pathway-driven CRC models (AACR 2022)
    ERAS-007 demonstrated monotherapy activity and combination benefit in cell-based assays as well as superior combination efficacy in vivo relative to respective monotherapy control arms.In summary, ERAS-007 demonstrates promising preclinical activity across a wide range of RAS/MAPK pathway-driven CRC models both as a monotherapy and in combination that support further exploration in the clinic. Accordingly, ERAS-007 combinations with encorafenib + cetuximab in BRAFV600E CRC and with palbociclib in KRASmut CRC are currently being evaluated in the HERKULES-3 phase 1b/2 master protocol (NCT05039177).
    Preclinical
    |
    KRAS (KRAS proto-oncogene GTPase) • NRAS (Neuroblastoma RAS viral oncogene homolog)
    |
    BRAF V600E • KRAS mutation • NRAS mutation • BRAF V600 • BRAF wild-type • RAS wild-type + BRAF wild-type
    |
    Erbitux (cetuximab) • Ibrance (palbociclib) • Braftovi (encorafenib) • ERAS-007