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MEHD7945A · 3 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| A: MEHD7945A | EXPERIMENTAL | - |
| B: Cetuximab | ACTIVE_COMPARATOR | - |
| A: MEHD7945A+ Cisplatin + 5-FU | EXPERIMENTAL | Participants with previously untreated R/M SCCHN will receive MEHD7945A 1650 milligrams (mg) intravenous (IV) infusion on Day 1 of each 21-day cycle until disease progression, unacceptable toxicity, or protocol violation. Cisplatin will be administered as 100 milligrams per square meter (mg/m\^2) IV infusion on Day 1 of Cycles 1 to 6. 5-FU will be administered as 1000 mg/m\^2/day administered as continuous infusion over Days 1-4 of Cycles 1 to 6. |
| B: MEHD7945A + Paclitaxel + Carboplatin | EXPERIMENTAL | Participants with previously untreated R/M SCCHN will receive MEHD7945A 1650 mg IV infusion on Day 1 of each 21-day cycle until disease progression, unacceptable toxicity, or protocol violation. Carboplatin will be administered at a dose to achieve an area under the curve (AUC) of 6 milligrams/milliliter/minute (mg/mL/min) as an IV infusion on Day 1 of Cycles 1 to 6. Paclitaxel will be administered as 200 mg/m\^2 IV infusion on Day 1 of Cycles 1 to 6. |
| Dose Escalation (MEHD7945A) | EXPERIMENTAL | Participants will receive intravenous (IV) infusion of MEHD7945A in escalating doses Q2W until MTD is reached or up to disease progression as determined by the investigator, intolerable toxicity, withdrawal of consent, or death, whichever occurs first. Approximately 5 dose levels between 1 and 30 mg/kg will be evaluated. |
| Dose Expansion (MEHD7945A) | EXPERIMENTAL | Participants will receive IV infusion of MEHD7945A Q2W at or below the MTD (decided from dose escalation part) up to disease progression as determined by the investigator, intolerable toxicity, withdrawal of consent, or death, whichever occurs first. |
| Name | Type | Description |
|---|---|---|
| MEHD7945A | DRUG | 1100 mg iv every 2 weeks |
| cetuximab | DRUG | 400 mg/m2 iv loading dose, followed by 250 mg/m2 weekly |
| 5-FU | DRUG | 5-FU will be administered as per schedule specified in the respective arm. |
| Carboplatin | DRUG | Carboplatin will be administered as per schedule specified in the respective arm. |
| Cisplatin | DRUG | Cisplatin will be administered as per schedule specified in the respective arm. |
| Paclitaxel | DRUG | Paclitaxel will be administered as per schedule specified in the respective arm. |
Inclusion Criteria: * Adult patients, \>/= 18 years of age * Histologically confirmed Stage III or IV recurrent/metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) * Progressive disease on or after first-line platinum-based chemotherapy regimen for R/M SCCHN (maximum of 6 cycles) * ...
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MEHD7945A is an investigational oncology drug being studied for the treatment of epithelial tumors, including malignant epithelial tumors and head and neck cancer, specifically recurrent or metastatic squamous cell carcinoma of the head and neck. It is a small molecule developed by Roche Holding AG.
MEHD7945A is a small molecule, but its specific molecular target is not disclosed in the available information. It is being studied in oncology for epithelial tumors and head and neck cancer, but the exact mechanism of action has not been specified.
MEHD7945A is being developed by Roche Holding AG, a pharmaceutical company. The developer's ticker symbol is RHHBY. Roche is conducting clinical trials to evaluate the safety and efficacy of MEHD7945A in patients with certain types of cancer.
MEHD7945A is in clinical development, with trials ranging from Phase 1 to Phase 2. It is not FDA approved and remains investigational. The most advanced trial is a Phase 2 study comparing MEHD7945A to cetuximab in head and neck cancer, which has been completed.
MEHD7945A has been studied in three completed clinical trials. NCT01207323 was a Phase 1 safety and pharmacokinetics study in epithelial tumors. NCT01577173 was a Phase 2 trial versus cetuximab in head and neck cancer. NCT01911598 was a Phase 1 combination study with chemotherapy in head and neck cancer.
No, MEHD7945A is not the same as cetuximab. In a Phase 2 clinical trial (NCT01577173), MEHD7945A was compared directly against cetuximab in patients with recurrent or metastatic squamous cell carcinoma of the head and neck, indicating they are distinct treatments.