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

Withdrawn before enrolling · Phase 1/Phase 2

Conditions studied: Acute Myeloid Leukemia

In brief

* 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.

Key facts

Study ID

NCT05279859

Run by

Erasca, Inc.

People needed

0

Starts

2022-03-15

Expected to finish

2025-06-01

Last updated by the study team

2022-06-15

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Diagnosis of AML secondary to prior chemotherapy or other neoplasms (except for MDS).
• Diagnosis of acute promyelocytic leukemia or BCR-ABL-positive leukemia (chronic myeologenous leukemia in blast crisis).
• Clinically active central nervous system leukemia.
• 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.
• 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.
• Palliative radiation ≤7 days prior to first dose.
• Major surgery within 28 days of enrollment.
• Contraindication to gilteritinib use as per local label.
• 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 thromboembolic or cerebrovascular events ≤6 months prior to first dose.
• History of other malignancy ≤3 years prior to first dose.
• 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.
• 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.
• Pregnant or breastfeeding women.

Where it is running

• University of California San Francisco — San Francisco, California, United States
• Texas Oncology — Dallas, Texas, United States
• The University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• NEXT Oncology Virginia — Fairfax, Virginia, United States

Full record on ClinicalTrials.gov

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