Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
IMGN632 · 2 trials · 3 indications
Evaluate the safety and tolerability and identify an RP2D of IMGN632 when administered in combination with azacitidine, with venetoclax, and with azacitidine and venetoclax in patients with relapsed or refractory CD123-positive AML through review of Treatment Emergent Adverse Events and abnormal laboratory values that result in a failure to meet the criteria for re-treatment.
Assess preliminary antileukemia activity of IMGN632 when administered as a monotherapy in MRD+ Fit and MRD + Unfit AML patient populations, and in combination with azacitidine, with venetoclax, and with azacitidine and venetoclax in patients with relapsed or untreated AML as assessed by complete response, complete remission with partial hematologic recovery, complete remission with incomplete platelet recovery, morphologic leukemia-free state, partial response, and duration of remission.
Assess Minimal Residual Disease Levels using central flow cytometry-based testing.
CR+clinical CR \[CRc\]
| Arm | Type | Description |
|---|---|---|
| Regimen A (Closed to Enrollment) | EXPERIMENTAL | IMGN632, administered intravenously on Day 7 of a 28 day cycle at 0.015 mg/kg, 0.045 mg/kg, or 0.09 mg/kg, in combination with azacitidine, administered subcutaneously or intravenously daily at 75 mg/m2 on Days 1 to 7 of a 28 day cycle. Cycle 1 azacitidine dose in subsequent cohorts may be reduced. |
| Regimen B (Closed to Enrollment) | EXPERIMENTAL | IMGN632, administered intravenously on Day 7 of a 21 day cycle at 0.015 mg/kg, 0.045 mg/kg, or 0.09 mg/kg, in combination with venetoclax, administered orally daily at 100 mg on Day 1, 200mg on Day 2, and 400 mg on the day 3 up to Day 21 of a 21 day cycle. Alternate schedules with reduced venetoclax administration may be explored. |
| Regimen C-Frontline&Relapsed/Refractory(Closed to Enrollment) | EXPERIMENTAL | IMGN632, administered intravenously on Day 7 of a 28 day cycle at 0.015 mg/kg or 0.045 mg/ kg, in combination with azacitidine, administered subcutaneously or intravenously daily at 35-75 mg/ m2 given for Days 1 to 7 of a 28 day cycle and venetoclax, administered orally daily at 100 mg on Day 1, 200mg on Day 2, and 400 mg on Day 3 up to Day 28 of a 28 day cycle. Alternate schedules with reduced venetoclax administration or reduced azacitidine dose or administration may be explored. |
| Regimen D (Closed to Enrollment) | EXPERIMENTAL | IMGN632, administered intravenously on Day 1 of a 21 day cycle at 0.045 mg/kg, as a monotherapy for Fit and Unfit MRD+ patients. |
| Escalation and Expansion | EXPERIMENTAL | Escalation: IMGN632 was administered by IV on 2 different schedules for participants with relapsed/refractory AML, ALL, or BPDCN. Expansion: IMGN632 was administered by IV: * Cohort 1: Relapsed or refractory BPDCN participants who have received 1-3 prior systemic therapies (incl. tagraxofusp-erzs and/or any other systemic therapy deemed appropriate for the treatment of BPDCN) * Cohort 2: Relapsed AML * Cohort 3: Relapsed or refractory ALL * Cohort 4: Other relapsed or refractory hematologic malignancies * Cohort 5: Relapsed or refractory AML at alternate dose or schedule * Cohort 6: Pivotal cohort for frontline BPDCN participants who have not received prior systemic therapy and participants with frontline BPDCN who have prior or concomitant hematologic malignancy (PCHM) and have not received prior systemic therapy. |
| Name | Type | Description |
|---|---|---|
| Azacitidine | DRUG | Commercially available formulation given subcutaneously (SC) or intravenous (IV) |
| IMGN632 | DRUG | Study formulation given intravenously (IV) |
| Venetoclax | DRUG | Commercially available formulation administered orally |
Inclusion Criteria: * Patient must be ≥ 18 years of age. * Patients must have confirmed diagnosis of AML (excluding acute promyelocytic leukemia) based on World Health Organization classification (Arber 2016). * Disease characteristics and allowable prior therapy: * Patients must be evaluated fo...
IMGN632 is an investigational small molecule being studied for the treatment of Acute Myeloid Leukemia and Blastic Plasmacytoid Dendritic Cell Neoplasm. It is currently in Phase 1 clinical development for these oncology indications.
IMGN632 is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol ABBV. The drug is currently in Phase 1 clinical trials.
IMGN632 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 1 trials are active but not recruiting participants.
IMGN632 is being studied in two Phase 1 trials. NCT03386513 evaluates the drug in patients with untreated and relapsed or refractory Blastic Plasmacytoid Dendritic Cell Neoplasm. NCT04086264 studies IMGN632 as monotherapy or in combination with venetoclax and/or azacitidine for CD123-positive Acute Myeloid Leukemia.
Yes, one clinical trial, NCT04086264, is studying IMGN632 as monotherapy or in combination with venetoclax and/or azacitidine for participants with CD123-positive Acute Myeloid Leukemia. This trial is in Phase 1 and is active but not recruiting.