GTAEXS617 for Cancer
(ELUCIDATE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new cancer drug called GTAEXS617. Researchers aim to determine its safety and effectiveness against advanced solid tumors, including certain types of head and neck, pancreatic, lung, breast, and ovarian cancers. The trial consists of two phases: one where participants receive increasing doses of the drug alone or with other standard treatments, and another where they receive a set dose. It may suit individuals with these specific cancers that have worsened despite previous treatments and who can tolerate the study conditions. As a Phase 1 trial, this research seeks to understand how the treatment works in people, offering participants the chance to be among the first to receive this new drug.
Do I have to stop taking my current medications for the trial?
The trial requires that you stop taking certain medications before starting the study treatment. Specifically, you must not have received anticancer therapy, or treatments that affect certain liver enzymes and proteins, within 14 days or 5 half-lives before the first dose. It's best to discuss your current medications with the trial team to see if they are affected.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that GTAEXS617 is a new treatment being tested for safety in people with advanced solid tumors. Although detailed data from human trials is limited, early studies of similar treatments often focus on determining safe dose levels. Researchers closely monitor these studies for any side effects to ensure they remain manageable.
GTAEXS617 is designed to be highly effective and selective, targeting cancer cells while sparing healthy ones. This approach can help reduce unwanted side effects.
Participants receive the treatment either alone or with standard cancer therapies. This helps doctors assess how well individuals tolerate the drug on its own or in combination with other treatments.
Overall, new treatments like GTAEXS617 undergo close monitoring to evaluate their effects on people, and any side effects are reported to enhance future safety.12345Why are researchers excited about this trial's treatment?
Researchers are excited about GTAEXS617 for cancer because it offers a novel approach by using an oral tablet form, making it potentially more convenient than traditional intravenous chemotherapy. Unlike many existing treatments, GTAEXS617 is designed to be used both as a monotherapy and in combination with standard treatments, which could enhance its effectiveness. Additionally, its dose escalation strategy aims to determine the most effective yet safe dosage, which could optimize patient outcomes.
What evidence suggests that this trial's treatments could be effective for cancer?
Research has shown that GTAEXS617 might help treat advanced solid tumors. In animal studies, the drug completely eliminated tumors, either by significantly reducing their size or removing them entirely. In a human study, one patient experienced a lasting partial response, with their tumor shrinking and remaining smaller for an extended period. Additionally, GTAEXS617 targeted cancer cells without damaging immune cells, potentially leading to fewer side effects. This trial will explore GTAEXS617 both as a monotherapy and in combination with standard treatments. These findings suggest that GTAEXS617 might effectively manage certain cancers, but further research with humans is needed to confirm these results.12367
Who Is on the Research Team?
Medical Director
Principal Investigator
Exscientia AI Ltd.
Are You a Good Fit for This Trial?
This trial is for adults with certain advanced solid tumors, including specific types of lung, breast, ovarian, and other cancers. Participants must have a good performance status (able to carry out daily activities), have tried standard treatments without success, and be healthy enough overall. They should also have tumors that can be biopsied.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Phase 1: Dose Escalation Monotherapy
Participants receive GTAEXS617 oral tablets in increasing doses
Phase 1: Dose Escalation Combination Therapy
Participants receive GTAEXS617 oral tablets in increasing doses in combination with standard of care treatment
Phase 2: Dose Expansion Monotherapy
Participants receive GTAEXS617 oral tablets at Recommended Phase 2 Dose (RP2D)
Phase 2: Dose Expansion Combination Therapy
Participants receive GTAEXS617 oral tablets at RP2D in combination with standard of care treatment
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- GTAEXS617
Trial Overview
The study is testing GTAEXS617-001's safety and effectiveness in shrinking or controlling tumor growth. It will look at how the body processes the drug (pharmacokinetics) and its impact on various advanced cancers compared to standard care.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Participants will receive GTAEXS617 oral tablets at Recommended Phase 2 Dose (RP2D).
Participants will receive GTAEXS617 oral tablets at RP2D in combination with SoC treatment.
Participants will receive GTAEXS617 oral tablets in increasing doses.
Participants will receive GTAEXS617 oral tablets in increasing doses in combination with standard of care (SoC) treatment.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Exscientia AI Limited
Lead Sponsor
Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc.
Lead Sponsor
GT Apeiron LLC
Collaborator
Citations
1.
investors.exscientia.ai
investors.exscientia.ai/press-releases/press-release-details/2022/Exscientia-Presents-Novel-Patient-Stratification-and-Biomarker-Data-for-GTAEXS-617-at-the-34th-EORTC-NCI-AACR-Annual-Symposium/default.aspxExscientia Presents Novel Patient Stratification and ...
In addition, the data showed that '617 induced less cell death on immune cells than select CDK4/6 and other investigational CDK7 inhibitors, ...
Gtaexs617 – Application in Therapy and Current Clinical ...
This phase 1/2 study aims to evaluate the safety, how the body processes the drug, and its effectiveness against various types of cancer. The trial focuses on ...
3.
aacrjournals.org
aacrjournals.org/cancerres/article/82/12_Supplement/3930/703291/Abstract-3930-AI-driven-discovery-and-profiling-ofAbstract 3930: AI-driven discovery and profiling of GTAEXS ...
In vivo, treatment of HGSOC and TNBC xenograft tumour-bearing mice with '617 results in complete tumour regression, with no impact on body ...
GTAEXS617 for Cancer (ELUCIDATE Trial)
Trial Overview The study is testing GTAEXS617-001's safety and effectiveness in shrinking or controlling tumor growth. It will look at how the body processes ...
NCT05985655 | Study to Assess GTAEXS617 in ...
The primary purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and anti-tumor activity of GTAEXS617-001 in participants with ...
6.
clinicaltrials.eu
clinicaltrials.eu/trial/study-on-the-safety-and-effectiveness-of-gtaexs617-for-patients-with-advanced-solid-tumors/Study on the Safety and Effectiveness of GTAEXS617 ...
This study investigates the safety and effectiveness of GTAEXS617, a novel treatment for patients with advanced solid tumors.
Study to Assess GTAEXS617 in Participants With Advanced ...
The primary purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and anti-tumor activity of GTAEXS617-001 in ...
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