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RO7283420 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Part A: Single Participant Dose Escalation | EXPERIMENTAL | Participants from Group I will receive escalating doses of RO7283420, once every 3 weeks (Q3W) starting on Cycle 1, Day 1 (C1D1) for up to 6 cycles with a starting dose of 0.15mg. |
| Part B: Multiple Participant Dose Escalation | EXPERIMENTAL | Multiple-participant cohorts of \>= 3 participants will be enrolled for dose escalation for Group I and Group II independently. Participants will be administered a starting dose of 0.15 mg or highest dose administered in Part A. Each participant will receive up to 6, 9, and 18 cycles of treatment with RO7283420, when treated with Q3W, every-2-weeks (Q2W), or once-a-week (QW) dosing regimens, respectively to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D). Additionally, step-up dosing regimens with more frequent administrations of RO7283420 during cycle 1 will be evaluated. |
| Part C: Dose Expansion | EXPERIMENTAL | Participants will receive the respective RP2D for Group I and Group II. |
| Name | Type | Description |
|---|---|---|
| RO7283420 | DRUG | RO7283420 will be administered to participants by intravenous (IV) infusion Q3W at a starting dose of 0.15mg. Starting dose levels (double step-up regimen, Q3W) for SC injections was the same as the highest dose levels that have been cleared in the IV double step-up cohorts at that timepoint. Each participant will receive up to 6, 9, and 18 cycles of treatment with RO7283420, when treated with Q3W, Q2W, or QW dosing regimens, respectively. |
| Tocilizumab | DRUG | Tocilizumab will be administered as an IV infusion 8 mg/kg (for participants with a weight of 30 kg and above) and 12 mg/kg (for participants with a weight of less than 30 kg). Tocilizumab will be given as rescue medication. |
| Dasatinib | DRUG | Dasatinib 100 mg film-coated tablets will be administered daily until symptom resolution (up to 100 mg twice daily \[BID\] for a maximum 3 days); orally. Dasatinib will be given as rescue medication. |
| Dexamethasone | DRUG | 20 mg IV of dexamethasone will be administered as pre-medication at least 60 minutes prior to the all RO7283420 infusions or injections during cycle 1. |
| Paracetamol/acetaminophen | DRUG | 500 or 1000 mg of paracetamol/acetaminophen will be administered orally or by IV as pre-medication at least 30 minutes prior to each RO7283420 infusion or injection. |
| Diphenhydramine | DRUG | 25 mg or 50 mg of diphenhydramine will be administered orally or by IV as pre-medication at least 30 minutes prior to each RO7283420 infusion or injection. |
Inclusion Criteria: * With confirmed diagnosis of primary or secondary AML according to WHO classification 2016, with measurable disease. Eligible participants need to have received standard-of-care (SOC) and have no other SOC options available Participants who are not willing to receive SOC will b...
RO7283420 is an investigational small molecule being studied for the treatment of Acute Myeloid Leukemia (AML). It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being evaluated for its safety, tolerability, pharmacokinetics, and pharmacodynamics in patients with AML.
RO7283420 is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical research on this investigational drug for Acute Myeloid Leukemia. Roche is responsible for the development and potential commercialization of RO7283420.
RO7283420 is in Phase 1 clinical development. It is an investigational drug and has not yet received FDA approval. The Phase 1 study has been completed, and the drug is not currently in active clinical trials. Further development status beyond Phase 1 has not been disclosed.
RO7283420 has one completed clinical trial with the identifier NCT04580121. This was a Phase 1 dose escalation and expansion study evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of the drug in patients with Acute Myeloid Leukemia. The trial enrolled 59 participants across multiple countries.
No alternative names for RO7283420 have been disclosed. The drug is identified solely by its code name RO7283420 in clinical trial records. It is an investigational small molecule being developed by Roche for Acute Myeloid Leukemia.