Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Dalantercept, ACE-041
Dalantercept plus sorafenib · 3 trials · 4 indications
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.
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 | EXPERIMENTAL | dalantercept |
| 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 |
| ACE-041 | EXPERIMENTAL | Patients assigned to 1 of 9 possible dosing groups |
| Name | Type | Description |
|---|---|---|
| Dalantercept | BIOLOGICAL | Subcutaneous dose of dalantercept once every 3 weeks. |
| Dalantercept plus sorafenib | DRUG | Subcutaneous (SC) injection of dalantercept once every 3 weeks and oral sorafenib daily. |
| ACE-041 | BIOLOGICAL | Subcutaneous dose of ACE-041 approximately once every 3 weeks for a total of 4 doses. If disease stays the same or gets better, additional study drug may be offered. |
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 plus sorafenib is an investigational combination of two small molecule drugs studied in advanced adult hepatocellular carcinoma. Dalantercept is a BMP10 and GDF2 inhibitor, and sorafenib is an approved multi-kinase inhibitor used in liver cancer. The combination was evaluated in a Phase 1 clinical trial and is not an approved regimen.
Dalantercept targets BMP10 and GDF2, two ligands of the activin receptor-like kinase 1 pathway, and acts as an inhibitor. Sorafenib targets multiple kinases involved in tumor growth and angiogenesis. Together the combination was designed to block BMP10 and GDF2 signaling alongside sorafenib's kinase inhibition in advanced hepatocellular carcinoma.
The combination is being developed by Merck & Company, Inc., which trades under the ticker MRK. Merck sponsored the clinical study of dalantercept with sorafenib in patients with advanced adult hepatocellular carcinoma. Dalantercept is the investigational agent in the combination.
Dalantercept plus sorafenib has been studied in a Phase 1 clinical trial in advanced adult hepatocellular carcinoma. The trial is completed, and the combination is investigational and not approved for any indication. Dalantercept as a single agent has also been studied in a Phase 2 trial in squamous cell carcinoma of the head and neck.
The combination was evaluated in NCT02024087, a completed Phase 1 study of dalantercept and sorafenib in patients with advanced adult hepatocellular carcinoma, enrolling 21 participants in the United States. Dalantercept alone was studied in NCT01458392, a completed Phase 2 trial in squamous cell carcinoma of the head and neck with 46 participants.
No. Dalantercept plus sorafenib refers to the combination of dalantercept with sorafenib, while dalantercept is the single investigational agent. Dalantercept is also known by that name alone. The combination was tested in hepatocellular carcinoma, and dalantercept alone was tested in squamous cell carcinoma of the head and neck.