* 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.
This is a Phase 1b/2, open-label, multicenter master protocol evaluating safety, tolerability, and preliminary efficacy of ERAS-007 or ERAS-601 in combination with other cancer therapies in study participants with hematologic malignancies. The study will commence with dose escalation cohorts (ERAS-007 plus gilteritinib and ERAS-601 plus gilteritinib) in study participants with relapsed or refractory (R/R) Feline McDonough sarcoma (FMS)-like tyrosine kinase 3 (FLT3) mutated acute myeloid leukemia (AML). Dose expansion will follow and will evaluate ERAS-007 or ERAS-601 drug combinations administered at the RD identified from each respective dose escalation cohort in study participants with R/R FLT-3 mutated AML.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
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
Dose Limiting Toxicities (DLT)
Based on adverse events observed during dose escalation
Time frame: Study Day 1 up to Day 29
Maximum Tolerated Dose (MTD)
Based on adverse events observed during dose escalation
Time frame: Study Day 1 up to Day 29
Recommended Dose (RD)
Based on adverse events observed during dose escalation
Time frame: Study Day 1 up to Day 29
Adverse Events
Incidence and severity of treatment-emergent AEs and serious AEs
Time frame: Assessed up to 24 months from time of first dose
Plasma concentration (Cmax)
Maximum plasma concentration of ERAS-007 or ERAS-601 and other cancer therapies
Time frame: Study Day 1 up to Day 29
Time to achieve Cmax (Tmax)
Time to achieve maximum plasma concentration of ERAS-007 or ERAS-601 and other cancer therapies
Time frame: Study Day 1 up to Day 29
Area under the curve
Area under the plasma concentration-time curve of ERAS-007 or ERAS-601 and other cancer therapies
Time frame: Study Day 1 up to Day 29
Half-life
Half-life of ERAS-007 or ERAS-601 and other cancer therapies
Time frame: Study Day 1 up to Day 29
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Antileukemic activity
Percentage of Participants With Complete Remission and Complete Remission With Partial Hematological Recovery (CR/CRh); CR rate
Time frame: Assessed up to 24 months from time of first dose
Duration of antileukemic activity
Duration of CR/CRh (DOCR/DOCRh)
Time frame: Assessed up to 24 months from time of first dose
Duration of antileukemic activity
Duration of CR (DOCR)
Time frame: Assessed up to 24 months from time of first dose