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Also known as GEN1046, DuoBody®-PD-L1×4-1BB, DuoBody®-PD-L1x4-1BB
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 studied in oncology for cutaneous melanoma that has relapsed or is refractory after checkpoint inhibitor therapy, and for PD-L1-positive locally advanced or metastatic non-small cell lung cancer. It is also being evaluated in advanced solid tumors. It is not approved for any indication.
Acasunlimab is being developed by Genmab A/S, which trades on Nasdaq under the ticker GMAB. Genmab is the sponsor of the clinical program, which includes trials in melanoma, non-small cell lung cancer, and advanced solid tumors.
Acasunlimab is in Phase 2 development overall, with a Phase 3 trial also under way in non-small cell lung cancer. The program includes a completed Phase 1 study, a Phase 2 study in metastatic NSCLC, a Phase 2 melanoma study, and a Phase 3 NSCLC trial.
Acasunlimab is being studied in NCT06984328, a Phase 2 trial in advanced cutaneous melanoma after checkpoint inhibitor therapy, and NCT06635824, a Phase 3 trial in PD-L1-positive locally advanced or metastatic NSCLC. Earlier trials include NCT05117242 in metastatic NSCLC and the completed Phase 1 study NCT04937153 in advanced solid tumors.
Yes, acasunlimab is also known as GEN1046. The earlier clinical trials, including NCT05117242 and NCT04937153, refer to the drug as GEN1046, while the newer melanoma and NSCLC trials use the name acasunlimab. Both names refer to the same investigational monoclonal antibody developed by Genmab.
No, acasunlimab is not FDA approved. It is an investigational monoclonal antibody still in clinical development, with Phase 1, Phase 2, and Phase 3 trials ongoing or completed. It has not received marketing authorization for any indication.