Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Trastuzumab emtansine [Kadcyla], trastuzumab-DM1, T-DM1
trastuzumab-MCC-DM1 · 1 trial · 1 indication
The time frame for AEs is study treatment initiation until 30 days after last administration of study treatment or at the time of initiation of another anti-cancer therapy, which ever occurs first. The time frame for SAEs is study treatment initiation until 90 days after last administration of study treatment or at the time of initiation of another anti-cancer therapy, which ever occurs first.
DLT is defined as one of the following as per investigator related to study drug: * Grade ≥ 3 non-hematologic, non-hepatic major organ toxicity * Grade ≥ 3 cardiac toxicity, including cardiac troponin I elevation or any new segmental wall abnormality as determined by non-invasive cardiac imaging * Grade ≥ 4 thrombocytopenia * Grade ≥ 4 neutropenia (absolute neutrophil count \< 500/μ L) lasting \> 4 days or accompanied by fever * Grade ≥ 4 anemia * Grade ≥ 3 serum bilirubin, hepatic transaminase (alanine aminotransferase or aspartate aminotransferase), or alkaline phosphatase For patients with Grade 2 hepatic transaminase or alkaline phosphatase levels at baseline as a result of liver metastases or bone metastases, a hepatic transaminase or alkaline phosphatase level ≥ 10 times the upper limit of normal will be considered a DLT. * Weekly cohorts only: Toxicity preventing retreatment on Cycle 1, Day 8 or toxicity preventing re-treatment on Cycle 1, Days 15 and Day 22
The highest dose level resulting in a DLT in ≤ 1 of 6 patients was declared the MTD.
Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| trastuzumab-MCC-DM1 | DRUG | Intravenous escalating dose |
Inclusion Criteria: * Histologically documented, incurable, locally advanced or metastatic breast cancer * Evaluable or measurable HER2-positive disease * History of progression during or within 60 days after treatment with any prior trastuzumab-containing chemotherapy regimen for HER2-positive bre...
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Trastuzumab-MCC-DM1 is an investigational monoclonal antibody-drug conjugate being developed by Roche Holding AG for HER2-positive metastatic breast cancer. It combines a trastuzumab antibody with the DM1 payload via an MCC linker. It is in Phase 1 clinical development and is not approved.
Trastuzumab-MCC-DM1 is being studied for the treatment of HER2-positive metastatic breast cancer in patients who have previously received a trastuzumab-containing regimen. It is an investigational agent and has not been approved for any indication.
Trastuzumab-MCC-DM1 targets ERBB2, also known as HER2. It is an inhibitor that binds to the ERBB2 receptor on cancer cells. The antibody component delivers the DM1 cytotoxic payload to HER2-expressing tumor cells.
Trastuzumab-MCC-DM1 is being developed by Roche Holding AG, which trades under the ticker RHHBY. Roche is the sponsor of the clinical program for this HER2-targeted antibody-drug conjugate.
Trastuzumab-MCC-DM1 is in Phase 1 clinical development. It is an investigational drug and has not received FDA approval. The Phase 1 trial has been completed.
Trastuzumab-MCC-DM1 has been evaluated in one completed Phase 1 trial, NCT00932373, titled A Study of Trastuzumab-MCC-DM1 Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer Who Have Previously Received a Trastuzumab-Containing Regimen. The trial enrolled 54 patients and was uncontrolled.