Xmab541, Xmab808
Ovarian Cancer
Phase I
Recruiting
Phase 1, Safety and Tolerability Study of XmAb541 and XmAb808 in Advanced Solid Tumors
May 11, 2026
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Xmab808, Keytruda
Urothelial Carcinoma, Colorectal Cancer, Head And Neck Squamous Cell Carcinoma, Castration-Resistant Prostate Cancer, Tnbc - Triple-Negative Breast Cancer, Melanoma Excluding Uveal Melanoma, Non-Small Cell Lung Cancer, Squamous Or Non-Squamous, Renal Cell Carcinoma, Clear Cell, Ovarian Cancer, Epithelial
Phase I
Completed
Phase 1, First-in-human, Dose-finding and Expansion Study to Evaluate XmAb®808 in Combination With Pembrolizumab in Advanced Solid Tumors
Oct 11, 2022
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Vudalimab + Carboplatin + Cabazitaxel, Vudalimab + Olaparib, Vudalimab Monotherapy, Vudalimab + Docetaxel, Vudalimab + Cabazitaxel Or Docetaxel
Metastatic Castration-Resistant Prostate Cancer
Phase II
Completed
XmAb®20717 (Vudalimab) Alone or in Combination With Chemotherapy or Targeted Therapy in Patients With Metastatic Castration-Resistant Prostate Cancer
Aug 05, 2021
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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 Xencor Inc (XE9) have in its pipeline
XE9 is currently developing the following drugs: Xmab412 Monoclonal Bispecific Antibody, Xmab541, Xmab808, Xmab13676. These drug candidates are in various stages of clinical development as the company works toward FDA approval.