Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Dalantercept plus sorafenib · 1 trial · 1 indication
Assessed by monitoring AEs using the current active minor version on the National Cancer Institute Common Toxicity Criteria for Adverse Events, version 4.0 (NCI-CTCAE v4 current minor version), physical examinations, vital signs, clinical laboratory test, ECHO, ECG and ADA testing; through final study visit, up to approximately 20 weeks from first dose of dalantercept.
| Arm | Type | Description |
|---|---|---|
| Dalantercept 0.6 mg/kg plus sorafenib 400 mg | EXPERIMENTAL | Cohort 1: Participants received dalantercept 0.6 mg/kg by subcutaneous (SC) injection once every 3 weeks plus sorafenib 400 mg orally (PO) once daily |
| Dalantercept 0.4 mg/kg plus sorafenib 400 mg | EXPERIMENTAL | Cohort 2: Participants will receive dalantercept 0.4 mg/kg SC injection once every 3 weeks plus sorafenib 400 mg PO once daily |
| Expansion cohort - dalantercept 0.4 mg/kg plus sorafenib 400 mg | EXPERIMENTAL | Cohort 3: Participants will receive dalantercept 0.4 mg/kg SC injection once every 3 weeks plus sorafenib 400 mg PO once daily |
| Name | Type | Description |
|---|---|---|
| Dalantercept plus sorafenib | DRUG | Subcutaneous (SC) injection of dalantercept once every 3 weeks and oral sorafenib daily. |
Inclusion Criteria: * Histologically confirmed, locally advanced or metastatic HCC. * Child-Pugh Score A (5-6) * At least one target lesion that has not been treated with local therapy and is measurable by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 * Eastern Cooperative Oncology Gro...
Dalantercept is an investigational monoclonal antibody being studied for the treatment of advanced adult hepatocellular carcinoma and squamous cell carcinoma of the head and neck. It is in Phase 2 clinical development for these oncology indications and is not yet approved by the FDA.
Dalantercept is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with certain types of cancer.
Dalantercept is in Phase 2 clinical development for advanced adult hepatocellular carcinoma and squamous cell carcinoma of the head and neck. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials.
Dalantercept has been studied in two completed clinical trials. NCT01458392 was a Phase 2 study in patients with squamous cell carcinoma of the head and neck, enrolling 46 participants. NCT02024087 was a Phase 1 study combining Dalantercept with sorafenib in patients with advanced hepatocellular carcinoma, enrolling 21 participants.
Dalantercept is a distinct investigational monoclonal antibody and is not known to be the same as any other approved drug. It is being studied as a monotherapy and in combination with sorafenib for different cancer types, but it has no alternative names listed in clinical trial records.