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NextCure Inc (NXTC)
NASDAQ:NXTC
Sim0505 For Injection
Advanced Solid Tumors
Phase I
Recruiting
A Phase I Study of SIM0505 in Participants With Advanced Solid Tumors
Jan 13, 2025
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Lncb74
Ovarian Cancer, Non-small Cell Lung Cancer, Breast Cancer, Advanced Or Metastatic Solid Tumors, Endometrial Cancer, Biliary Tract Cancer
Phase I
Recruiting
A Phase 1 Study of LNCB74 in Advanced Solid Tumors
Jan 08, 2025
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Nc525
Relapsed Or Refractory Acute Myeloid Leukemia, Relapsed Or Refractory Chronic Myelomonocytic Leukemia, Relapsed Or Refractory Myelodysplastic Syndrome
Phase I
Terminated
A Safety, Tolerability and Efficacy Study of NC525 in Subjects With Advanced Myeloid Neoplasms
Feb 08, 2023
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Pembrolizumab, Nc410
Cervical Cancer, Ovarian Cancer, Advanced Or Metastatic Solid Tumors, Lung Cancer, Gastric Cancer, Endometrial Cancer, Esophageal Cancer, Head Neck Cancer, Colo-Rectal Cancer, Microsatellite Instability Low, Microsatellite Instability High, Microsatellite Stable
Phase I/II
Active Not Recruiting
A Safety, Tolerability and Efficacy Study of NC410 Plus Pembrolizumab in Participants with Advanced Unresectable or Metastatic Solid Tumors
Oct 05, 2022
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Nc762
Ovarian Cancer, Non-small Cell Lung Cancer, Breast Cancer, Advanced Or Metastatic Solid Tumors
Phase I/II
Terminated
A Safety and Tolerability Study of NC762 in Subjects With Advanced or Metastatic Solid Tumors
May 03, 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 NextCure Inc (NXTC) have in its pipeline
NXTC is currently developing the following drugs: Sim0505 For Injection, Lncb74, Nc525. These drug candidates are in various stages of clinical development as the company works toward FDA approval.