A Study of Anti-Cancer Therapies Targeting the MAPK Pathway in Patients With Hematologic Malignancies

Trial details

Who runs it

Erasca, Inc.

Trial code

NCT05279859

Record updated

2022. június 15.

Original description

* To evaluate the safety and tolerability of escalating doses of ERAS-007 or ERAS-601 in combination with other cancer therapies in study participants with hematologic malignancies. * To determine the Maximum Tolerated Dose (MTD) and/or Recommended Dose (RD) of ERAS-007 or ERAS-601 administered in combination with other cancer therapies. * To evaluate the preliminary efficacy of ERAS-007 or ERAS-601 in combination with other cancer therapies in study participants with hematologic malignancies. * To evaluate the PK profiles of ERAS-007 or ERAS-601 and other cancer therapies when administered in combination.Read full original descriptionShow less

A Phase 1b/2 Master Protocol of Agents Targeting the Mitogen-Activated Protein Kinase Pathway in Patients With Hematologic Malignancies

* To evaluate the safety and tolerability of escalating doses of ERAS-007 or ERAS-601 in combination with other cancer therapies in study participants with hematologic malignancies. * To determine the Maximum Tolerated Dose (MTD) and/or Recommended Dose (RD) of ERAS-007 or ERAS-601 administered in combination with other cancer therapies. * To evaluate the preliminary efficacy of ERAS-007 or ERAS-601 in combination with other cancer therapies in study participants with hematologic malignancies. * To evaluate the PK profiles of ERAS-007 or ERAS-601 and other cancer therapies when administered in combination.

Inclusion: Age ≥ 18 years; Willing and able to give written informed consent; Diagnosis of primary AML or AML secondary to myelodysplastic syndrome (MDS) according to World Health Organization classification; Relapsed after or refractory to first-line AML therapy; Positive for FLT3 mutation in bone marrow or whole blood; Eastern Cooperative Oncology Group performance status ≤ 2 with no deterioration during screening period; Adequate hepatic and renal function; Recovery from non-hematologic AEs associated with prior therapy to baseline CTCAE v5 Grade 0 or 1, except for AEs not considered a safety risk (eg, alopecia or vitiligo); Able to take oral medication with no medical conditions that prevent swallowing and absorbing oral medications; Willing to comply with all protocol-required visits, assessments, and procedures.

Exclusion: Diagnosis of AML secondary to prior chemotherapy or other neoplasms (except for MDS); Second or later hematologic relapse or prior salvage therapy for refractory disease; For participants being considered for ERAS-007+gilteritinib treatment: prior therapy with ERK inhibitor; For participants being considered for ERAS-601+gilteritinib treatment: prior therapy with SHP2 inhibitor; Palliative radiation ≤7 days prior to first dose; Major surgery within 28 days of enrollment; History of thromboembolic or cerebrovascular events ≤6 months prior to first dose; Known hypersensitivity to any of the components of ERAS-007 or ERAS-601; Clinically active infection, requiring systemic therapy; Impaired cardiovascular function or clinically significant cardiovascular disease; History of retinal pigment epithelial detachment (RPED), central serous retinopathy, retinal vein occlusion (RVO), or risk factors to RPED or RVO; History of or clinically active interstitial lung disease (ILD), drug induced ILD, or radiation pneumonitis that required steroid treatment; Anticancer therapy ≤14 days prior to first dose (except hydroxyurea given for controlling blast count), or ≤5 half-lives prior to first dose, whichever is shorter; Any evidence of severe or uncontrolled systemic disease or evidence of any other significant clinical disorder or laboratory finding that renders the participant inappropriate to participate in the study; History of other malignancy ≤3 years prior to first dose; Diagnosis of acute promyelocytic leukemia or BCR-ABL-positive leukemia (chronic myeologenous leukemia in blast crisis); Clinically active central nervous system leukemia; Contraindication to gilteritinib use as per local label; Pregnant or breastfeeding women.

ClinicalTrials.gov NCT05279859