Acasunlimab
Sponsors
Genmab A/S, Genmab
Conditions
Advanced Endometrial CancerCutaneous MelanomaIIICLocally Advanced Unresectable Melanoma (Stage IIIBMalignant Solid Tumors - Non Small Cell Lung CancerMalignant solid tumors: endometrial carcinoma (EC)Metastatic Cutaneous Melanoma (Stage IV)Non Small Cell Lung Cancer Metastatic
Phase 1
GEN1046 Safety Trial in Patients With Malignant Solid Tumors
Active, not recruitingNCT03917381
Start: 2019-05-14End: 2026-02-01Updated: 2026-02-11
GEN1046 Safety and PK in Subjects With Advanced Solid Malignancies
CompletedNCT04937153
Start: 2021-06-15End: 2024-10-01Updated: 2025-07-16
First-in-human, open-label, dose-escalation trial with expansion cohorts to evaluate safety of GEN1046 in subjects with malignant solid tumors
Active, not recruitingCTIS2023-509059-15-00
Start: 2019-04-30Target: 295Updated: 2026-01-16
Phase 2
Safety and Efficacy Study of GEN1046 as a Single Agent or in Combination With Pembrolizumab for Treatment of Recurrent (Non-small Cell) Lung Cancer
Active, not recruitingNCT05117242
Start: 2021-10-27End: 2027-05-27Updated: 2025-11-06
GEN1046 in Combination With Anticancer Agents for the Treatment of Advanced Endometrial Cancer
WithdrawnNCT06046274
Start: 2023-10-01End: 2028-06-01Updated: 2024-04-30
A Phase 2, multicenter, randomized, open-label trial of GEN1046 as monotherapy and in combination with Pembrolizumab in subjects with relapsed/refractory metastatic non-small cell lung cancer after treatment with standard care therapy with a immune checkpoint inhibitor.
Active, not recruitingCTIS2024-513770-22-00
Start: 2021-09-22Target: 100Updated: 2025-09-30
Study of the Effectiveness and Safety of Acasunlimab Alone and With Pembrolizumab to Treat Advanced Melanoma of the Skin That Has Returned After Treatment With an Approved Checkpoint Inhibitor Therapy (ABBIL1TY MELANOMA-07)
Active, not recruitingNCT06984328
Start: 2025-07-25End: 2029-07-15Updated: 2026-03-03
Efficacy and Safety Study of Acasunlimab as Monotherapy and in Combination With Pembrolizumab in Subjects With Relapsed/Refractory, Unresectable Locally Advanced or Metastatic Cutaneous Melanoma That Progressed On or After Treatment With a Checkpoint Inhibitor
CompletedCTIS2025-520468-16-00
End: 2026-01-19Target: 129Updated: 2025-10-27
Phase 3
Trial to Evaluate Acasunlimab and Pembrolizumab Combination Superiority Over Standard of Care Docetaxel in Non-Small Cell Lung Cancer (ABBIL1TY NSCLC-06)
Active, not recruitingNCT06635824
Start: 2024-11-25End: 2028-09-30Updated: 2026-03-12
A Prospective, Open-Label, Randomized, Phase 3 Trial of Acasunlimab (GEN1046) in Combination With Pembrolizumab Versus Docetaxel in Subjects With PD-L1 Positive Metastatic Non-Small Cell Lung Cancer After Treatment With a PD-1/PD-L1 Inhibitor and Platinum-Containing Chemotherapy (ABBIL1TY NSCLC-06)
Active, not recruitingCTIS2024-512998-27-00
Start: 2025-02-21Target: 398Updated: 2025-11-27