Genmab A/S (GMAB)
NASDAQ:GMAB
Gen1106
Solid Tumors, Urothelial Carcinoma
Phase I
Recruiting
A Study of GEN1106 in Participants With Solid Tumors
Feb 10, 2026
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Epcoritamab, Investigator's Choice Chemotherapy
Diffuse Large B-Cell Lymphoma
Phase III
Active Not Recruiting
A Sub-study Trial of Epcoritamab vs Investigator's Choice Chemotherapy in Relapsed/Refractory Diffuse Large B-cell Lymphoma (R/R DLBCL) in China
Nov 06, 2025
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Bevacizumab, Rina-S
Platinum-sensitive Ovarian Cancer, Ovarian Cancer, Psoc
Phase III
Recruiting
Study to Assess the Efficacy and Safety of Rina-S Plus Standard of Care Compared to Standard of Care for Maintenance Treatment of Participants With Recurrent Platinum-sensitive Ovarian Cancer After Second-line (2L) Platinum-based Doublet Chemotherapy
Nov 04, 2025
Bevacizumab, Bnt327, Bnt314, Soc Chemotherapy Treatment 1, Soc Chemotherapy Treatment 2
Metastatic Colorectal Cancer
Phase I/II
Recruiting
A Clinical Study to Test if an Investigational Treatment Called BNT314 When Used in Combination With Another Investigational Treatment BNT327 and Chemotherapy, is Beneficial and Safe for Patients With Advanced Colorectal Cancer
Jul 09, 2025
Pembrolizumab, Acasunlimab
Cutaneous Melanoma, Relapsed/Refractory, Locally Advanced Unresectable Melanoma (Stage Iiib, Iiic, Or Iiid), Metastatic Cutaneous Melanoma (Stage Iv)
Phase II
Active Not Recruiting
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)
May 14, 2025
FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Genmab A/S (GMAB) have in its pipeline
GMAB is currently developing the following drugs: Gen1106, Gen1079, Gen3018. These drug candidates are in various stages of clinical development as the company works toward FDA approval.