Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Dalantercept · 1 trial · 1 indication
ORR is defined as the proportion of patients who met criteria for complete response or partial response. Patients were evaluable for ORR if they had at least one measurable lesion at baseline and at least one disease assessment after baseline. RECIST version 1.1 was used to evaluate efficacy. In addition, patients who developed clinical or radiological progression of disease prior to the scheduled tumor assessment were also considered evaluable for response. The response rate was estimated as the proportion of patients evaluable for response who meet the criteria for complete (CR) and partial response (PR). Per RECIST v1.1 for target lesions and assessed by MRI: complete response (CR), disappearance of all target lesions; partial response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; overall response (OR) = CR + PR.
| Arm | Type | Description |
|---|---|---|
| Dalantercept | EXPERIMENTAL | dalantercept |
| Name | Type | Description |
|---|---|---|
| Dalantercept | BIOLOGICAL | Subcutaneous dose of dalantercept once every 3 weeks. |
Key Inclusion Criteria: * Histologically and/or cytologically confirmed, recurrent or metastatic SCCHN of mucosal origin (oral cavity, oropharynx, hypopharynx or larynx) not amenable to further local therapy (surgery, or radiation including re-irradiation); patients with unknown primary SCCHN presu...
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.