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    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:
    14d
    HERKULES-3: A Study of ERAS-007 in Patients With Advanced Gastrointestinal Malignancies (clinicaltrials.gov)
    P1/2, N=101, Completed, Erasca, Inc. | Active, not recruiting --> Completed
    Trial completion
    |
    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
    1year
    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
    2years
    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
    almost3years
    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
    almost3years
    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
    almost3years
    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
    3years
    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
    almost4years
    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
    4years
    ­­­­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