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Acasunlimab · 5 trials · 7 indications
Assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
| Arm | Type | Description |
|---|---|---|
| Acasunlimab in Combination with Pembrolizumab | EXPERIMENTAL | Participants with relapsed/refractory, unresectable locally advanced or metastatic cutaneous melanoma that progressed on/after prior CPI(s) will receive acasunlimab once every 6 weeks (Q6W) in combination with pembrolizumab Q6W. |
| Acasunlimab | EXPERIMENTAL | Participants with relapsed/refractory, unresectable locally advanced or metastatic cutaneous melanoma that progressed on/after prior CPI(s) will receive acasunlimab Q6W. |
| Name | Type | Description |
|---|---|---|
| Acasunlimab | DRUG | IV infusion |
| Pembrolizumab | DRUG | IV infusion |
| Docetaxel | DRUG | IV infusion |
| Acasunlimab in combination with docetaxel (in a single expansion cohort) | BIOLOGICAL | Acasunlimab and docetaxel will be administered intravenously once every 21 days. |
| Acasunlimab in combination with pembrolizumab (in a separate expansion cohort) | BIOLOGICAL | Acasunlimab and pembrolizumab will be administered intravenously once every 21 days or every 42 days, respectively. |
| Acasunlimab in combination with pembrolizumab and standard chemotherapy (in separate expansion cohorts) | BIOLOGICAL | Acasunlimab and pembrolizumab and standard chemotherapy will be administered intravenously once every 21 days for 4 cycles, followed by treatment with acasunlimab and pembrolizumab once every 21 days. |
Key Inclusion Criteria: * Participants ≥ 18 years of age with histologically or cytologically confirmed diagnosis of relapsed/refractory, locally advanced unresectable (Stage IIIB, IIIC, or IIID) or metastatic (Stage IV) cutaneous melanoma, per American Joint Committee on Cancer (8th edition) stagi...
Acasunlimab is an investigational monoclonal antibody being developed for the treatment of solid tumors, including PD-L1-positive locally advanced unresectable Stage IIIB/C or metastatic non-small cell lung cancer (NSCLC) and cutaneous melanoma. It is also being studied in metastatic NSCLC and other solid tumor types.
Acasunlimab is being developed by Genmab A/S, a biotechnology company traded on the Nasdaq under the ticker GMAB. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with various advanced solid malignancies.
Acasunlimab is currently in Phase 2 clinical development. It has completed a Phase 1 trial and is being evaluated in Phase 1/2 and Phase 2 studies. A Phase 3 trial has also been initiated, though the drug remains investigational and is not yet approved.
Acasunlimab is being studied in several clinical trials, including NCT03917381, a Phase 1/2 safety trial in patients with malignant solid tumors; NCT04937153, a completed Phase 1 study; NCT05117242, a Phase 2 trial in metastatic NSCLC; and NCT06635824, a Phase 3 trial evaluating the drug in combination with pembrolizumab.
Yes, Acasunlimab is also known as GEN1046. Clinical trial records refer to the drug by both names, with GEN1046 used in earlier studies and Acasunlimab appearing in more recent trial titles, such as the Phase 3 ABBIL1TY NSCLC-06 study.
Acasunlimab is a monoclonal antibody, a type of targeted therapy that binds to specific proteins involved in cancer growth. As an antibody, it is designed to interfere with tumor cell signaling or immune system interactions, though its precise molecular target has not been specified in available information.