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ADC Therapeutics Ltd (ADCT)
NYSE:ADCT
Loncastuximab Tesirine
Diffuse Large B-Cell Lymphoma, High-Grade B-Cell Lymphoma
Phase I
Recruiting
A Study to Evaluate the Pharmacokinetics and Safety of Loncastuximab Tesirine in Participants With Relapsed or Refractory Diffuse Large B-cell Lymphoma or High-grade B-cell Lymphoma With Hepatic Impairment (LOTIS-10)
Dec 13, 2022
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Gemcitabine, Adct-601
Advanced Solid Tumors
Phase I
Terminated
A Study of Mipasetamab Uzoptirine (ADCT-601) in Participants With Solid Tumors
May 20, 2022
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Rituximab, Loncastuximab Tesirine
Diffuse Large B-Cell Lymphoma
Phase II
Terminated
A Study of Loncastuximab Tesirine and Rituximab (Lonca-R) in Previously Untreated Unfit/Frail Participants With Diffuse Large B-cell Lymphoma (DLBCL)
Nov 22, 2021
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Adct-901
Advanced Solid Tumors
Phase I
Completed
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of ADCT-901 in Participants With Selected Advanced Solid Tumors
Jul 13, 2021
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Obinutuzumab, Loncastuximab Tesirine, Glofitamab, Polatuzumab Vedotin, Mosunetuzumab
B-Cell Non-Hodgkin Lymphoma, Refractory B-Cell Non-Hodgkin Lymphoma, Relapsed B-Cell Non-Hodgkin Lymphoma
Phase I
Recruiting
A Study to Evaluate the Safety and Anti-cancer Activity of Loncastuximab Tesirine in Combination With Other Anti-cancer Agents in Participants With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (LOTIS-7)
Jul 12, 2021
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Gemcitabine, Rituximab, Oxaliplatin, Loncastuximab Tesirine
Relapsed Diffuse Large B-Cell Lymphoma, Refractory Diffuse Large B-Cell Lymphoma
Phase III
Active Not Recruiting
Study to Evaluate Loncastuximab Tesirine With Rituximab Versus Immunochemotherapy in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
May 08, 2020
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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 ADC Therapeutics Ltd (ADCT) have in its pipeline
ADCT is currently developing the following drugs: Loncastuximab Tesirine, Gemcitabine, Adct-601, Rituximab, Loncastuximab Tesirine. These drug candidates are in various stages of clinical development as the company works toward FDA approval.