Table 4.
Clinical trials of Menin inhibitors
| Agent | Disease | Phase | Enrollment | NCT.gov identifier | Status |
|---|---|---|---|---|---|
| Revumenib (SNDX-5613) | |||||
| Revumenib with Azacitidine + Venetoclax | Patients with NPM1-mutated or KMT2A-rearranged AML | Phase 3 | 415 | NCT06652438 | Not yet recruiting |
| Revumenib | Patients with KMT2A-Rearranged or NPM1-Mutated Acute Leukemia After AHSCT | Phase 1 | 27 | NCT06575296 | Not yet recruiting |
| Revumenib With 7 + 3 + Midostaurin | AML | Phase 1 | 22 | NCT06313437 | Not yet recruiting |
| Revumenib and Venetoclax | AML MRD positive | Phase 2 | 8 | NCT06284486 | Recruiting |
| Revumenib | Leukemia Associated with Upregulation of HOX Genes | Phase 2 | 15 | NCT06229912 | Recruiting |
| Revumenib and Gilteritinib | R/R FLT3-Mutated AML and Concurrent MLL-Rearrangement or NPM1 Mutation | Phase 1 | 30 | NCT06222580 | Recruiting |
| Revumenib, Azacitidine, and Venetoclax | in Pediatric and Young Adult Patients With R/R AML | Phase 1 | 24 | NCT06177067 | Recruiting |
| Revumenib + Daunorubicin and Cytarabine | Newly Diagnosed AML Patients with Changes in NPM1 or MLL/KMT2A Gene | Phase 1 | 28 | NCT05886049 | Recruiting |
| Revumenib in Combination with Chemotherapy | Patients Diagnosed with R/R Leukemia | Phase 2 | 78 | NCT05761171 | Recruiting |
| Radiolabeled Revumenib | Adults with Acute Leukemia | Phase 1 | 8 | NCT05406817 | Recruiting |
| Revumenib in Combination with Chemotherapy | Participants With R/R Acute Leukemia | Phase 1 | 30 | NCT05326516 | Completed |
| Revumenib | R/R Leukemias Including Those with an MLL/KMT2A Gene Rearrangement or NPM1 Mutation | Phase 1/2 | 413 |
(AUGMENT-101) |
Recruiting |
| Ziftomenib (KO-539) | |||||
| Ziftomenib With Venetoclax and Gemtuzumab | Pediatric Patients With AML | Phase 1 | 22 | NCT06448013 | Not yet recruiting |
| Ziftomenib | Maintenance Post Allo-HCT in AML with NPM1m and KMT2A-r | Phase 1 | 22 | NCT06440135 | Recruiting |
| Ziftomenib, Venetoclax and Azacitidine | in Pediatric R/R Acute Leukemias | Phase 1 | 22 | NCT06397027 | Not yet recruiting |
| Ziftomenib in Combination with Chemotherapy | Children with R/R Acute Leukemia | Phase 1 | 20 | NCT06376162 | Not yet recruiting |
| Safety and Tolerability of Ziftomenib Combinations | KMT2A-r or NPM1-m R/R AML | Phase 1 | 171 e | NCT06001788 | Recruiting |
| Ziftomenib with Venetoclax/Azacitidine, Venetoclax, or 7 + 3 | Patients with AML | Phase 1 | 212 | NCT05735184 | Recruiting |
| Ziftomenib | Patients With R/R AML | Phase 1/2 | 199 | NCT04067336 | Recruiting |
| DSP-5336 | |||||
| DSP-5336 | R/R AML/ ALL with or Without KMT2A-r or NPM1-m | Phase 1/2 | 70 | NCT04988555 | Recruiting |
| DS-1594b | |||||
| DS-1594bWith or Without Azacitidine, Venetoclax, or Mini-HCVD | R/R AML or ALL | Phase 1/2 | 17 | NCT04752163 | Completed |
| Bleximenib (JNJ-75276617) | |||||
| Bleximenib in Combination with Conventional Chemotherapy | Pediatric and Young Adult Participants with Relapsed/Refractory Acute Leukemias | Phase 1 | 0 | NCT05521087 | Withdrawn |
| Bleximenib in Combination with Directed Therapies | Patients with AML | Phase 1 | 200 | NCT05453903 | Recruiting |
| Bleximenib | patients With Acute Leukemia | Phase 1/2 | 400 | NCT04811560 | Recruiting |
| BMF-219 | |||||
| BMF-219 | Adult Patients With AML, ALL (With KMT2A/MLL1r, NPM1 Mutations), DLBCL, MM, and CLL/SLL | Phase 1 | 177 | NCT05153330 | Recruiting |
| BN104 | |||||
| BN104 | Acute Leukemia | Phase 1/2 | 90 | NCT06052813 | Recruiting |