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Preclinical Development: Overview

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Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...
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Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
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Drugs, the chemical agents used in diagnosing, treating, or preventing diseases, undergo a four-phase process of development: pharmaceutic, pharmacokinetics, pharmacodynamics, and therapeutic.
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Phase 0 Radiopharmaceutical-Agent Clinical Development.

Charles A Kunos1, Larry V Rubinstein1, Jacek Capala2

  • 1Cancer Therapy Evaluation Program, National Cancer Institute, Bethesda, MD, United States.

Frontiers in Oncology
|October 5, 2020
PubMed
Summary
This summary is machine-generated.

Phase 0 clinical trials offer a flexible approach for evaluating antibody- or peptide-targeted radiopharmaceuticals in combination cancer therapy. This strategy aids in studying drug pharmacokinetics, dosimetry, and predictive biomarkers for improved therapeutic success.

Keywords:
cancernational cancer institute (NCI)phase 0 clinical trialradiopharmaceuticalradiotherapy

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Area of Science:

  • Oncology
  • Radiopharmaceutical Therapy
  • Clinical Trial Design

Background:

  • Evaluating targeted radiopharmaceuticals in monotherapy or combination regimens necessitates robust collaboration within cancer research networks.
  • The National Cancer Institute (NCI) clinical trial enterprise plays a key role in advancing these complex studies.

Purpose of the Study:

  • To discuss a Phase 0 clinical development framework for antibody- or peptide-targeted radiopharmaceutical-agent combinations.
  • To highlight the utility of Phase 0 trials in assessing novel cancer therapeutic strategies.

Main Methods:

  • Phase 0 trials serve as a flexible platform for investigating radiopharmaceutical-drug interactions.
  • Key areas of study include pharmacokinetics, radiation dosimetry, and biomarkers of DNA damage response.
  • Pharmacodynamic benchmarks predictive of therapeutic outcomes are also assessed.

Main Results:

  • Phase 0 trials facilitate early assessment of radiopharmaceutical combinations.
  • This approach allows for the evaluation of drug interactions and predictive biomarkers in a controlled setting.

Conclusions:

  • Phase 0 trials are a valuable tool for the early-phase development of targeted radiopharmaceutical combinations.
  • These trials are expected to become more prevalent in NCI's Cancer Therapy Evaluation Program for advancing oncological treatments.