Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
DCLL9718S · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Arm A: DCLL9718S | EXPERIMENTAL | Participants will receive escalating doses of DCLL9718S intravenously (IV) in each 21-day cycle to determine MTD and RP2D in dose-escalation stage followed by DCLL9718S IV at RP2D in each 21-day cycle in dose-expansion stage until disease progression, unacceptable toxicity, or any other discontinuation criteria are met. |
| Arm B: DCLL9718S and Azacitidine | EXPERIMENTAL | Participants will receive escalating doses of DCLL9718S (starting dose: at least one dose level below a completed and tolerated DCLL9718S monotherapy in Arm A) IV in each 28-day cycle and azacitidine 75 milligrams per square meter (mg/m\^2) subcutaneously (SC) or IV on Days 1-7 of each 28-day cycle to determine MTD and RP2D of DCLL9718S in dose-escalation stage followed by DCLL9718S IV at RP2D in each 28-day cycle and azacitidine 75 mg/m\^2 SC or IV on Days 1-7 of each 28-day cycle in dose-expansion stage until disease progression, unacceptable toxicity, or any other discontinuation criteria are met. Azacitidine may also be given on Days 1-5 and Days 8-9 depending on institutional preference. |
| Name | Type | Description |
|---|---|---|
| DCLL9718S | DRUG | DCLL9718S will be administered as per the schedule specified in the respective arm. |
| Azacitidine | DRUG | Azacitidine will be administered as per the schedule specified in the respective arm. |
Inclusion Criteria: * Diagnosis of AML per World Health Organization (WHO) criteria (except acute promyelocytic leukemia) * Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1, or 2 * Adequate end-organ function * Willing and able to undergo a pre-treatment bone marrow aspira...
DCLL9718S is an investigational small molecule being studied for acute myeloid leukemia (AML). A Phase 1 trial evaluated DCLL9718S in participants with relapsed or refractory AML, and DCLL9718S in combination with azacitidine in participants with previously untreated AML unsuitable for intensive induction chemotherapy.
DCLL9718S is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical research on this investigational small molecule for the treatment of acute myeloid leukemia.
DCLL9718S is in Phase 1 clinical development. The single Phase 1 trial has been completed, and DCLL9718S remains an investigational drug that has not been approved by regulatory authorities.
DCLL9718S has one completed Phase 1 trial, NCT03298516, which enrolled 19 participants in the United States and Canada. The study evaluated DCLL9718S alone in relapsed or refractory acute myeloid leukemia and in combination with azacitidine in previously untreated AML.
No alternative names for DCLL9718S have been reported. The drug is identified by its code name DCLL9718S in clinical trial records and is not known to be marketed under any other brand name.