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Acasunlimab

Phase 3

PD-L1-positive, Locally Advanced (Unresectable Stage IIIB/C) or Metastatic NSCLC | Small molecule | Oncology |Genmab A/S|Last Updated: Jun 2, 2026

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Trial Design
UNCONTROLLED
Total Trials1
Total Enrollment191
FDA Designations
No designations recorded
Clinical trial landscape

Acasunlimab · 5 trials · 7 indications

Phase 3 1Phase 2 2Phase 1/2 1Phase 1 1
NCT06635824Trial to Evaluate Acasunlimab and Pembrolizumab Combination Superiority Over Standard of Care Docetaxel in Non-Small Cell Lung Cancer (ABBIL1TY NSCLC-06)PD-L1-positive, Locally Advanced (Unresectable Stage IIIB/C) or Metastatic NSCLC
ACTIVE NOT_RECRUITING191 Analytics
PHASE3ACTIVE NOT_RECRUITING
Trial to Evaluate Acasunlimab and Pembrolizumab Combination Superiority Over Standard of Care Docetaxel in Non-Small Cell Lung Cancer (ABBIL1TY NSCLC-06)
PD-L1-positive, Locally Advanced (Unresectable Stage IIIB/C) or Metastatic NSCLCUnlock trial analytics
Study Endpoints
Primary Endpoints
Objective Response Rate (ORR)
Up to approximately 12 months

Assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

Secondary Endpoints
Time to Response (TTR)
Up to approximately 15 months
Duration of Response (DOR)
Up to approximately 15 months
Progression-free Survival (PFS)
Up to approximately 15 months
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Study Design & Arms
Treatment Arms
ArmTypeDescription
Acasunlimab in Combination with PembrolizumabEXPERIMENTALParticipants 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.
AcasunlimabEXPERIMENTALParticipants with relapsed/refractory, unresectable locally advanced or metastatic cutaneous melanoma that progressed on/after prior CPI(s) will receive acasunlimab Q6W.
Interventions
NameTypeDescription
AcasunlimabDRUGIV infusion
PembrolizumabDRUGIV infusion
DocetaxelDRUGIV infusion
Acasunlimab in combination with docetaxel (in a single expansion cohort)BIOLOGICALAcasunlimab and docetaxel will be administered intravenously once every 21 days.
Acasunlimab in combination with pembrolizumab (in a separate expansion cohort)BIOLOGICALAcasunlimab 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)BIOLOGICALAcasunlimab 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.
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Eligibility Criteria
Age Range18 Years to N/A
SexALL

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...

Countries:United StatesPuerto Rico
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Recent Changes (Last 90 Days)
LOWJun 2, 2026NCT06984328lastUpdatePostDate: changed
LOWJun 2, 2026NCT06984328lastUpdatePostDate: changed
LOWJun 2, 2026NCT06984328lastUpdatePostDate: changed
LOWMay 26, 2026NCT06984328primaryCompletionDate: changed
LOWMay 24, 2026NCT03917381studyFirstPostDate: changed
LOWMay 24, 2026NCT05117242studyFirstPostDate: changed
LOWMay 24, 2026NCT06635824studyFirstPostDate: changed
LOWMay 24, 2026NCT06984328studyFirstPostDate: changed