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ZE46-0134 · 1 trial · 1 indication
To determine the maximum tolerated dose or biologically effective dose of ZE46-0134 in adults with FLT3 and spliceosome mutated relapsed and refractory AML.
| Arm | Type | Description |
|---|---|---|
| ZE46-0134 Dose Level -1 | EXPERIMENTAL | Optional and would only be performed Dose Level 1 is poorly tolerated |
| ZE46-0134 Dose Level 1 | EXPERIMENTAL | - |
| ZE46-0134 Dose Level 2 | EXPERIMENTAL | - |
| ZE46-0134 Dose Level 3 | EXPERIMENTAL | - |
| ZE46-0134 Dose Level 4 | EXPERIMENTAL | - |
| ZE46-0134 Dose Level 5 | EXPERIMENTAL | - |
| ZE46-0134 Selected dose 1 | EXPERIMENTAL | The doses used in Part 2 of the study will be determined based on the data from Part 1 of the study and will not exceed a loading dose of 150 mg x 2 days and maintenance dose of 50 mg QD |
| ZE46-0134 Selected dose 2 | EXPERIMENTAL | The doses used in Part 2 of the study will be determined based on the data from Part 1 of the study and will not exceed a loading dose of 150 mg x 2 days and maintenance dose of 50 mg QD |
| ZE46-0134 Dose Level 6 | EXPERIMENTAL | - |
| ZE46-0134 Dose Level 7 | EXPERIMENTAL | - |
| ZE46-0134 Dose Level 8 | EXPERIMENTAL | - |
| ZE50-0134 (Group 2) Dose Level -1 | EXPERIMENTAL | Optional and would only be performed Dose Level 1 is poorly tolerated |
| ZE50-0134 (Group 2) Dose Level 1 | EXPERIMENTAL | - |
| ZE50-0134 (Group 2) Dose Level 2 | EXPERIMENTAL | - |
| ZE50-0134 (Group 2) Dose Level 3 | EXPERIMENTAL | - |
| ZE50-0134 (Group 2) Dose Level 4 | EXPERIMENTAL | - |
| ZE50-0134 (Group 2) Selected dose 1 | EXPERIMENTAL | The doses used in Part 2 of the study will be determined based on the data from Part 1 of the study. |
| ZE50-0134 (Group 2) Selected dose 2 | EXPERIMENTAL | The doses used in Part 2 of the study will be determined based on the data from Part 1 of the study. |
| Name | Type | Description |
|---|---|---|
| ZE46-0134 | DRUG | oral capsules QD |
Inclusion Criteria: 1. Written Informed Consent must be obtained from the patient or legally authorized representative prior to any study-related procedures (including withdrawal of prohibited medication, if applicable). 2. Patient is ≥18 years of age at the time of obtaining informed consent. 3. P...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Tango Therapeutics, Inc. | TNGX | 1 | PHASE1 | TNG462, RMC-9805, RMC-6236, mFOLFIRINOX, gemcitabine/nab-paclitaxel |
| Pasithea Therapeutics Corp. | KTTA | 1 | PHASE1 | PAS-004 |
| Adlai Nortye Ltd. Sponsored ADR | ANL | 1 | PHASE1 | AN9025 |
| Myriad Genetics, Inc. | MYGN | 1 | PHASE1 | Melphalan, BCNU, Vitamin B12B, Vitamin C |
ZE46-0134 is an investigational small molecule being developed for the treatment of acute myeloid leukemia (AML) with gene mutations, specifically in adults with FLT3 mutated or spliceosome mutated relapsed or refractory AML. It is currently in Phase 1 clinical development.
ZE46-0134 is being studied in patients with FLT3 mutated or spliceosome mutated relapsed or refractory acute myeloid leukemia. The clinical trial evaluates its safety, pharmacokinetics, pharmacodynamics, and efficacy in this biomarker-selected patient population.
ZE46-0134 is being developed by cbdMD, Inc., a company traded on the NYSE American under the ticker symbol YCBD. The drug is currently in Phase 1 clinical development for AML with gene mutations.
ZE46-0134 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 trial is currently recruiting participants to evaluate the drug in adults with relapsed or refractory acute myeloid leukemia.
ZE46-0134 is being studied in a Phase 1 clinical trial with the identifier NCT06366789. This is a dose escalation and expansion study evaluating the safety, pharmacokinetics, pharmacodynamics, and efficacy of ZE46-0134 in adults with FLT3 mutated or spliceosome mutated relapsed or refractory acute myeloid leukemia.
The Phase 1 clinical trial of ZE46-0134 is being conducted in the United States, Australia, South Korea, and Taiwan. The trial is recruiting adults aged 18 years and older with relapsed or refractory acute myeloid leukemia with specific gene mutations.