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Xencor Inc (XNCR)
NASDAQ:XNCR
Xmab942
Ulcerative Colitis (Uc)
Phase I/II
Recruiting
Study of XmAb942 in Healthy Participants and Participants With Ulcerative Colitis
Sep 20, 2024
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Xmab541
Ovarian Cancer, Endometrial Cancer, Testicular Germ Cell Tumor, Germ Cell Tumor, Ovarian Germ Cell Tumor
Phase I
Recruiting
Phase 1, Safety and Tolerability Study of XmAb541 in Advanced Solid Tumors
Feb 16, 2024
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Vudalimab + Carboplatin + Pemetrexed, Pembrolizumab + Carboplatin + Pemetrexed
Nonsquamous Non-Small Cell Lung Cancer
Phase I/II
Recruiting
Study of Vudalimab or Pembrolizumab in Combination With Chemotherapy as First-line Treatment in Patients With Advanced NSCLC
Nov 13, 2023
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Xmab®808, Keytruda® (Pembrolizumab)
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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Xmab819
Clear Cell Renal Cell Carcinoma
Phase I
Recruiting
Study of XmAb®819 in Subjects With Advanced Clear Cell Renal Cell Carcinoma
Jun 13, 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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Xmab13676
Chronic Lymphocytic Leukemia, B-Cell Non-Hodgkins Lymphoma
Phase I
Completed
Study to Evaluate Safety and Tolerability of XmAb13676 (Plamotamab) in Patients With CD20-expressing Hematologic Malignancies
Sep 14, 2016
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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 (XNCR) have in its pipeline
XNCR is currently developing the following drugs: Xmab942, Xmab541, Vudalimab + Carboplatin + Pemetrexed, Pembrolizumab + Carboplatin + Pemetrexed. These drug candidates are in various stages of clinical development as the company works toward FDA approval.