A Phase 1/2, Multicenter, Open-label Study of IMGN632 Monotherapy Administered Intravenously in Patients with CD123-positive Acute Myeloid Leukemia and Other CD123-positive Hematologic Malignancies

Conditions

Acute Myeloid Leukemia and other blood cancers

Brief summary

Escalation Phase: MTD and RP2D, BPDCN: CR+clinical CR [CRc]

Detailed description

Treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and DLTs, PK parameters, including but not limited to observed maximum concentration (Cmax) and area under the concentration versus time curve (AUC), To evaluate the potential immunogenecity of IMGN632 - ADA, Overall response rate (OOR) (CR without minimal residual disease [CRMRD- ] + CR + complete remission with partial hematologic recovery [CRh] + complete remission with incomplete recovery [CRi] + morphologic leukemia-free state [MLFS] + partial response [PR]), complete remission rate (CRMRD-, CR, CRh), composite complete remission (CCR) rate (CRMRD-, CR, CRh, CRi), and time to event outcomes (duration of overall response [DOR], event-free survival, relapse-free survival, OS)., BPDCN Expansion Phase (Cohorts 1 and 6): CR+CRc, BPDCN Expansion Phase (Cohorts 1 and 6): ADA, BPDCN Expansion Phase (Cohorts 1 and 6): Conversion rate to independence of red blood cell and platelet transfusion relative to baseline

Related papers

No related papers found yet.

Interventions

DRUGPIVEKIMAB SUNIRINE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Escalation Phase: MTD and RP2D, BPDCN: CR+clinical CR [CRc]	—

Secondary

Measure	Time frame
Treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and DLTs, PK parameters, including but not limited to observed maximum concentration (Cmax) and area under the concentration versus time curve (AUC), To evaluate the potential immunogenecity of IMGN632 - ADA, Overall response rate (OOR) (CR without minimal residual disease [CRMRD- ] + CR + complete remission with partial hematologic recovery [CRh] + complete remission with incomplete recovery [CRi] + morphologic leukemia-free state [MLFS] + partial response [PR]), complete remission rate (CRMRD-, CR, CRh), composite complete remission (CCR) rate (CRMRD-, CR, CRh, CRi), and time to event outcomes (duration of overall response [DOR], event-free survival, relapse-free survival, OS)., BPDCN Expansion Phase (Cohorts 1 and 6): CR+CRc, BPDCN Expansion Phase (Cohorts 1 and 6): ADA, BPDCN Expansion Phase (Cohorts 1 and 6): Conversion rate to independence of red blood cell and platelet transfusion relative to baseline	—

Measure

Time frame

Treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and DLTs, PK parameters, including but not limited to observed maximum concentration (Cmax) and area under the concentration versus time curve (AUC), To evaluate the potential immunogenecity of IMGN632 - ADA, Overall response rate (OOR) (CR without minimal residual disease [CRMRD- ] + CR + complete remission with partial hematologic recovery [CRh] + complete remission with incomplete recovery [CRi] + morphologic leukemia-free state [MLFS] + partial response [PR]), complete remission rate (CRMRD-, CR, CRh), composite complete remission (CCR) rate (CRMRD-, CR, CRh, CRi), and time to event outcomes (duration of overall response [DOR], event-free survival, relapse-free survival, OS)., BPDCN Expansion Phase (Cohorts 1 and 6): CR+CRc, BPDCN Expansion Phase (Cohorts 1 and 6): ADA, BPDCN Expansion Phase (Cohorts 1 and 6): Conversion rate to independence of red blood cell and platelet transfusion relative to baseline

—

Countries

France, Spain

Outcome results

None listed