GTAEXS617 for Cancer

(ELUCIDATE Trial)

Recruiting at 12 trial locations

Overseen By Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc.

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Exscientia AI Limited

Must not be taking: CYP3A inhibitors, P-gp inducers

Disqualifiers: Active infection, CNS malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

165 Participants Needed

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. ^{1 2 3 4 5}

Why 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. ^{1 2 3 6 7}

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

I am fully active or can carry out light work.

My cancer is one of the specified types and stages.

My cancer cannot be cured with surgery or radiation and has come back or spread after standard treatments.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1: Dose Escalation Monotherapy

Participants receive GTAEXS617 oral tablets in increasing doses

8-12 weeks

Phase 1: Dose Escalation Combination Therapy

Participants receive GTAEXS617 oral tablets in increasing doses in combination with standard of care treatment

8-12 weeks

Phase 2: Dose Expansion Monotherapy

Participants receive GTAEXS617 oral tablets at Recommended Phase 2 Dose (RP2D)

12-16 weeks

Phase 2: Dose Expansion Combination Therapy

Participants receive GTAEXS617 oral tablets at RP2D in combination with standard of care treatment

12-16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

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?

Group I: Phase 2: Dose Expansion Monotherapy Experimental Treatment 1 Intervention

Participants will receive GTAEXS617 oral tablets at Recommended Phase 2 Dose (RP2D).

Group II: Phase 2: Dose Expansion Combination Therapy Experimental Treatment 2 Interventions

Participants will receive GTAEXS617 oral tablets at RP2D in combination with SoC treatment.

Group III: Phase 1: Dose Escalation Monotherapy Experimental Treatment 1 Intervention

Participants will receive GTAEXS617 oral tablets in increasing doses.

Group IV: Phase 1: Dose Escalation Combination Therapy Experimental Treatment 2 Interventions

Participants will receive GTAEXS617 oral tablets in increasing doses in combination with standard of care (SoC) treatment.

Who Is Running the Clinical Trial?

Exscientia AI Limited

Lead Sponsor

Trials

5

Recruited

400+

Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc.

Lead Sponsor

GT Apeiron LLC

Collaborator

Trials

1

Recruited

170+

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.aspx

Exscientia 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, ...

2. clinicaltrials.eu clinicaltrials.eu/inn/gtaexs617/

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-of

Abstract 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 ...

4. withpower.com withpower.com/trial/phase-2-neoplasms-6-2023-bc629

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 ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05985655

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.

7. ctv.veeva.com ctv.veeva.com/study/study-to-assess-gtaexs617-in-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 ...