Tag: oncology
Clinical Research: Phase 1 - Phase 4
Regulatory Challenges in Global CAR-T Cell Therapy Development
When exploring the complex and rigorous regulatory landscape for CAR-T cell therapies, sponsors may encounter challenges in their efforts to bring products to market Since the historic approval of Kymriah® (tisagenlecleucel) in 2017, research on chimeric antigen receptor (CAR) T cell therapy has accelerated. There are more than 230 regenerative medicine companies in Europe and...
Clinical Research: Phase 1 - Phase 4
Adaptive Trial Designs in Early Oncology: Minimizing Risk & Accelerating Timelines
Introduction Over the past decade, significant advances have improved our understanding of the genetic and molecular mechanisms that lead to cancer. And yet, a recent review of the oncology drugs approved by the U.S. Food and Drug Administration (FDA) on the basis of response rate showed only 10 percent of these therapies demonstrate an overall...
Premier Research Adds to Diverse Team of Oncology Experts
Oncology Expert Dr. Cassandra Matney Joins Global CRO DURHAM, N.C., August 3, 2020 — Premier Research continues to build its oncology expertise with the addition of Cassandra Matney, M.D., as Senior Medical Director. Matney joins a diversely talented team of oncology experts who have managed more than 170 oncology trials over the past five years....
Clinical Research: Phase 1 - Phase 4
Finding the Fast Track in Early-Phase Oncology Trials
Put yourself in this scenario: Your compound is a newly validated mutated receptor that is present in only a limited number of cancer patients, and there is no approved diagnostic test. Your product, an antibody-like molecule that inhibits the receptor’s activity, also stimulates a potent immune response. Further complicating things, much of the preclinical data...
Patient and Stakeholder Engagement
The Art and Science of Selecting Patients for Phase 1 Oncology Studies
The primary purpose of early-stage clinical trials is to determine the recommended dose and toxicity profile of an investigational drug or multi-drug combination therapy. Since molecularly targeted agents (MTAs) and immunotherapies have toxicities that are distinct from cytotoxic chemotherapies, traditional dose escalation methods using toxicity-based endpoints may not be suitable for phase I studies of...
Clinical Research: Phase 1 - Phase 4
Key Considerations When Designing a Phase 1 Oncology Trial
Traditionally, phase 1 oncology trials have relied on a standard 3+3 dose escalation design to achieve the objective of defining a recommended phase 2 dose (RP2D). However, statistical simulations have shown that as few as one in three trials using the 3+3 design succeed in identifying the maximum tolerated dose.[1] Concerns have also been raised...
Clinical Research: Phase 1 - Phase 4
Boosting Immuno-Oncology’s Effectiveness Against Cancer
Immuno-oncology continues to be an exciting frontier in the fight against cancer. Researchers continue to develop drugs that allow the body to weaponize its own immune system against the growth of new tumors. Most uses of immunotherapies have been limited to cancers, like those in the lungs or pancreas, that produce a strong immune response. In his article...
Clinical Research: Phase 1 - Phase 4
CAR T-cell Therapies: Safety Considerations and Toxicity Management
Immuno-gene therapeutics are transforming the therapeutic landscape of hematological malignancies. The recent approvals of two chimeric antigen receptor (CAR) T-cell therapies—tisagenlecleucel (marketed as Kymriah™) and axicabtagene ciloleucel (marketed as Yescarta™)—mark the beginning of the next revolution in cancer treatment. However, along with demonstrated efficacy in hematologic malignancies, CAR T-cells have the capacity to elicit serious...
Study Design
6 Early Phase Dose-Finding Trial Designs for Oncology Therapeutics
Phase I and II trials may have different overall goals (i.e., demonstrating safety vs. efficacy), but the two both struggle with a major challenge in oncology study design: finding the right dose. Luckily, decades of data and innovations have given researchers the tools necessary to plan a successful dose-finding trial. Read on for a look...