Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Duligotuzumab
MEHD7945A · 4 trials · 3 indications
| Arm | Type | Description |
|---|---|---|
| FOLFIRI + Cetuximab | ACTIVE_COMPARATOR | - |
| FOLFIRI + MEHD7945A | EXPERIMENTAL | - |
| 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 |
|---|---|---|
| 5-fluorouracil | DRUG | Standard 5-fluorouracil (5-FU) chemotherapy (400 milligram per square meter \[mg/m\^2\] administered as intravenous bolus and then 5-FU 2400 mg/m\^2 administered as continuous intravenous infusion over 46 +/- 2 hours) or according to local standard-of-care prescribing information's, every 2 weeks until documented disease progression or unacceptable toxicity. |
| Cetuximab | DRUG | Cetuximab 400 mg/m\^2 intravenous infusion as a loading dose on Day 1 Cycle 1, followed by 250 mg/m\^2 intravenous infusion weekly until documented disease progression or unacceptable toxicity. |
| Irinotecan | DRUG | Standard Irinotecan chemotherapy (180 milligram per square meter \[mg/m\^2\] administered as intravenous infusion over 60 +/- 30 minutes) or according to local standard-of-care prescribing information's, every 2 weeks until documented disease progression or unacceptable toxicity. |
| Leucovorin | DRUG | Standard Leucovorin chemotherapy (400 mg/m\^2 \[racemic form\] or 200 mg/m\^2 \[L-isomer form\] administered by intravenous infusion over 120 +/- 10 minutes) or according to local standard-of-care prescribing information's, every 2 weeks until documented disease progression or unacceptable toxicity. |
| MEHD7945A | DRUG | MEHD7945A 1100 milligram (mg) intravenous infusion every 2 weeks until documented disease progression or unacceptable toxicity. |
| 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: * Histologically or cytologically confirmed adenocarcinoma of the colon and/or rectum, with KRAS wild-type status * Progressive disease on or after first-line oxaliplatin-containing regimen for mCRC; participants must have received oxaliplatin-containing chemotherapy for greater...
Top 20 of 80 competitors
MEHD7945A was studied in oncology for colorectal cancer, epithelial tumors, and head and neck cancer. Its clinical program focused on KRAS wild-type metastatic colorectal cancer and recurrent or metastatic squamous cell carcinoma of the head and neck. All reported trials are completed, and the drug remains investigational rather than approved.
MEHD7945A was developed by Roche Holding AG, which trades over the counter under the ticker RHHBY. Roche sponsored the clinical program evaluating the agent in colorectal cancer, epithelial tumors, and head and neck cancer.
MEHD7945A reached Phase 2 clinical development, with Phase 1 studies also conducted. It is investigational and has not been approved for any indication. The Phase 2 work covered KRAS wild-type metastatic colorectal cancer and recurrent or metastatic squamous cell carcinoma of the head and neck.
Four completed trials are registered for MEHD7945A: NCT01911598 in recurrent or metastatic head and neck cancer, NCT01652482 in KRAS wild-type metastatic colorectal cancer, NCT01577173 in recurrent or metastatic head and neck cancer, and NCT01207323 in locally advanced or metastatic epithelial tumors. Total enrollment across these studies was 347 participants.
MEHD7945A is a small molecule studied in oncology, and its trials used biomarker selection, including KRAS wild-type status in the colorectal cancer study. The registered studies evaluated it both as monotherapy and in combination regimens, including FOLFIRI and platinum-based chemotherapy.
MEHD7945A is not approved and remains an investigational agent. Its clinical program consisted of completed Phase 1 and Phase 2 trials in colorectal cancer, epithelial tumors, and head and neck cancer, with no active trials currently listed.