Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
DHES0815A · 1 trial · 1 indication
AE is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. SAE is any AE that is fatal, is life threatening, requires or prolongs inpatient hospitalization, results in persistent/significant disability/incapacity and is congenital anomaly/birth defect. Severity of AEs were graded per NCI CTCAE v4.0. Grade 1: Mild; asymptomatic/mild symptoms; clinical/diagnostic observations only; or intervention not indicated; Grade 2: Moderate; minimal, local/non-invasive intervention indicated; or limiting age-appropriate instrumental activities of daily living; Grade 3: Severe/medically significant, but not immediately life-threatening: hospitalization/prolongation of hospitalization indicated; disabling/limiting self-care activities of daily living; Grade 4: Life-threatening consequences/urgent intervention indicated; Grade 5: Death related to AE.
DLT=any one events occurring during DLT assessment window: ≥15% decrease from baseline in left ventricular ejection fraction (LVEF)/≥10% decrease to \<50% LVEF; Grade ≥ 3 non-hematologic toxicity; Grade ≥4 neutropenia (absolute neutrophil count \<500 cells/microliters \[μL\]) lasting \<7 days; Grade ≥3 febrile neutropenia; Grade ≥4 anemia; Grade ≥4 thrombocytopenia; Grade 3 thrombocytopenia associated with clinically significant bleeding; Any increase in hepatic transaminase (ALT or AST) \>3\*baseline in combination with either an increase in direct bilirubin \>2\*upper limit of normal/clinical jaundice, in absence of cholestasis/other contributory factors. NCI CTCAE v4.0. was used to grade these events.Grade1: Mild; asymptomatic/mild symptoms; clinical/diagnostic observations only; Grade2: Moderate; minimal, local/non-invasive intervention indicated;Grade3: Severe/medically significant, but not immediately life-threatening;Grade4: Life-threatening consequences/urgent intervention indicated.
Treatment duration was calculated from the first dose of study drug to the last dose of study drug administration.
LVEF is the fraction of blood (in percent) pumped out of the heart's left ventricular chamber with each heartbeat and is a measure of cardiac output for the heart. Baseline LVEF value and the change from baseline to the worst value in LVEF measurement were reported. LVEF was measured by ECHO or MUGA scan.
| Arm | Type | Description |
|---|---|---|
| Dose Escalation Cohort: DHES0815A | EXPERIMENTAL | Participants will receive DHES0815A in escalating doses in the dose-escalation cohort of the study. Participants will receive additional infusions of DHES0815A on Day 1 of subsequent cycles provided that they meet the protocol specified criteria for acceptable toxicity and ongoing clinical benefit. |
| Dose Expansion Cohort: DHES0815A | EXPERIMENTAL | Participants will be treated at or below the Maximum Tolerated Dose (MTD) of DHES0815A (based on the review of the totality of the data) to obtain additional safety, tolerability, PK, and anti-tumor activity data. |
| Name | Type | Description |
|---|---|---|
| DHES0815A | DRUG | DHES0815A will be administered via intravenous (IV) infusion on Day 1 of each 21-day cycle. |
Key Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Measurable disease by RECIST v1.1 with at least one measurable target lesion * Locally advanced or metastatic HER2-positive breast cancer that has relapsed or is refractory to established therapies * ...
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DHES0815A is an investigational small molecule being studied for the treatment of HER2-positive breast cancer. It was evaluated in a Phase 1 study in participants with this biomarker-selected form of breast cancer. It is not approved for any indication and remains in clinical development.
DHES0815A is being developed by Roche Holding AG, which trades under the ticker RHHBY. Roche sponsored the Phase 1 clinical study of the drug in HER2-positive breast cancer.
DHES0815A is in Phase 1 development. Its only recorded clinical trial, NCT03451162, was a Phase 1 study that has since been completed. The drug is investigational and has not been approved by the FDA for any indication.
DHES0815A was studied in one clinical trial, NCT03451162, titled a Safety, Tolerability, and Pharmacokinetic Study of DHES0815A in Participants With HER2-Positive Breast Cancer. The Phase 1 trial enrolled 14 participants across the United States and South Korea and is now completed.
No. DHES0815A is an investigational drug in Phase 1 clinical development and has not been approved by the FDA. Its single completed Phase 1 trial evaluated safety, tolerability, and pharmacokinetics in participants with HER2-positive breast cancer.