CGT4255 for Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called CGT4255 to determine its safety and effectiveness for individuals with advanced solid tumors, particularly those with ERBB2 gene changes or high HER2 protein levels. The study includes different parts to identify the optimal dose and understand the drug's effects in the body. Individuals with advanced breast cancer who are aware of these specific gene changes or protein levels might be suitable candidates for this trial. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in humans.
Is there any evidence suggesting that CGT4255 is likely to be safe for humans?
Research shows that CGT4255 looks promising in early tests. Studies have found that this treatment specifically targets HER2, a protein linked to some cancers. Initial lab tests suggest a low risk of the drug interacting with other medications, a positive sign for safety.
However, since CGT4255 remains in the early stages of testing, information from human trials is limited. These early trials aim to assess how well people tolerate the drug and identify any side effects. While lab tests provide some confidence in the drug's safety, researchers continue to monitor its effects in humans to confirm these results.
Prospective trial participants should understand that these early stages are crucial for ensuring the treatment's safety and tolerability. Discuss any concerns with the research team conducting the trial.12345Why do researchers think this study treatment might be promising?
Researchers are excited about CGT4255 for breast cancer because it offers a unique approach compared to traditional treatments like chemotherapy, hormone therapy, or targeted therapy. Unlike these standard options, CGT4255 is administered orally, which can be more convenient and less invasive for patients. Furthermore, CGT4255 may work by a novel mechanism that targets specific pathways involved in cancer growth, potentially leading to fewer side effects and better effectiveness. This fresh angle gives hope for improved outcomes and a higher quality of life for patients battling breast cancer.
What evidence suggests that CGT4255 might be an effective treatment for breast cancer?
Research has shown that CGT4255 is a promising treatment for breast cancer with high levels of HER2, a protein that promotes cancer cell growth. CGT4255 targets and blocks this protein, which can slow down or shrink tumors. Importantly, it does not affect a similar protein called EGFR, helping to reduce side effects. This trial will explore different dosing strategies for CGT4255, including dose escalation and signal seeking, to determine its effectiveness in treating HER2-positive breast cancer. In previous studies, when combined with another cancer drug, sunitinib, CGT4255 led to a measurable reduction in tumors for nearly half of the patients, suggesting its potential effectiveness.45678
Are You a Good Fit for This Trial?
This trial is for adults with advanced solid tumors, such as breast or non-small cell lung cancer, that have changes in the ERBB2 gene or too much HER2 protein. Specific eligibility details are not provided but typically include good organ function and no conflicting medications.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Participants receive multiple doses of CGT4255 for oral administration to determine the maximum tolerated dose (MTD) or the maximum evaluated dose (MED)
Signal Seeking and Dose Optimization
Participants receive oral doses of CGT4255 at selected dose levels determined in Phase 1 to evaluate safety and efficacy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- CGT4255
Trial Overview
The study tests CGT4255, a new drug targeting ERBB2 alterations in cancer cells. It's an early-phase trial to assess how safe it is, what the body does to it, its effects on the body and if it can shrink tumors.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Part B: Signal Seeking and Dose Optimization Oral dose(s) of CGT4255 at the selected dose levels determined in Phase 1
Part C: Includes signal seeking. Participants will receive CGT4255 at a dose level selected based on data from Part A
Part A: Dose Escalation Multiple doses of CGT4255 for oral administration
Find a Clinic Near You
Who Is Running the Clinical Trial?
Cogent Biosciences, Inc.
Lead Sponsor
Citations
Characterization of a Novel, EGFR Sparing, ErbB2 Inhibitor ...
• ErbB2 drives breast cancer growth through amplification or genetic mutations leading to constitutive activation and increased downstream ...
CGT-4255 - Drug Targets, Indications, Patents
The tyrosine kinase inhibitor, in combination with approved cancer med sunitinib, was tied to an objective response rate (ORR) of 46% in patients with ...
CGT4255 is an EGFR Sparing, Pan-Mutant HER2 Clinical ...
•These data support the clinical investigation of CGT4255 in HER2-YVMA lung cancer ... Breast Cancer Research (2023), 25:81, 1-14.
4.
oncologynewscentral.com
oncologynewscentral.com/slideshow/wave-of-pivotal-data-hits-her2-positive-breast-cancer-careWave of Pivotal Data Hits HER2-Positive Breast Cancer Care
Long-Term Outcomes ... As of the data cutoff, there was a 17% reduction in the risk for death for patients who were treated with the pertuzumab- ...
5.
finance.yahoo.com
finance.yahoo.com/news/cogent-biosciences-presents-preclinical-data-140000339.htmlCogent Biosciences Presents New Preclinical Data ...
Novel EGFR-sparing, brain-penetrant ErbB2 inhibitor demonstrates superior efficacy profile reaching 80% brain penetrance with potent ...
CGT4255 Brain Penetrant HER2 Selective Clinical ...
Breast Cancer Research (2023), 25:81, 1-14. (d) CGT4255 is not a P ... • Low DDI risk based on in vitro safety panel. • Low nM potency ...
A Study of a Selective ERBB2 Inhibitor (CGT4255), in ...
This is an open-label, phase 1/1b study evaluating the safety, tolerability, pharmacokinetic (what the body does to the drug), pharmacodynamic (what the drug ...
8.
tipranks.com
tipranks.com/news/company-announcements/cogent-biosciences-expands-her2-oncology-footprint-with-new-early-stage-cgt4255-trialCogent Biosciences Expands HER2 Oncology Footprint ...
Intervention/Treatment: The treatment is CGT4255, a selective ERBB2 (HER2) inhibitor taken by mouth once daily. It is designed to block HER2- ...
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