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Study to Assess GTAEXS617 in Patients With Advanced Solid Tumors (ELUCIDATE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05985655
Recruitment Status : Recruiting
First Posted : August 14, 2023
Last Update Posted : March 5, 2024
Sponsor:
Collaborator:
GT Apeiron LLC
Information provided by (Responsible Party):
Exscientia AI Limited

Study Description
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Brief Summary:
A phase 1/2 study to assess the safety, tolerability, pharmacokinetics and anti-tumor activity of GTAEXS617-001 in patients with advanced solid tumors.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumor Drug: GTAEXS617 Phase 1 Phase 2

Detailed Description:
A phase 1/2 study to assess the safety, tolerability, pharmacokinetics and anti-tumor activity of GTAEXS617-001 as monotherapy and in combination, in patients with one of the following advanced solid tumors: head and neck squamous cell carcinoma, colorectal adenocarcinoma, pancreatic adenocarcinoma, non-small cell lung cancer, breast cancer (HR+ and HER2- that has progressed to a prior treatment with CD4/CDK6 inhibitor), ovarian epithelial carcinoma.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2 Open-label Multicenter Study to Assess the Safety, Pharmacokinetics, and Anti-tumor Activity of GTAEXS617 in Patients With Advanced Solid Tumors
Actual Study Start Date : July 6, 2023
Estimated Primary Completion Date : January 2028
Estimated Study Completion Date : May 2028
Arms and Interventions
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Arm Intervention/treatment
Experimental: GTAEXS617
GTAEXS617 tablet for oral administration
 Drug: GTAEXS617
GTAEXS617 tablets daily


Outcome Measures
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Primary Outcome Measures :
  1. Module 1 Part A: To characterize the safety profile of GTAEXS617 as monotherapy [ Time Frame: Through patient study completion, an average of 6 months ]
    Incidence of treatment-emergent adverse events (TEAEs), characterised by type, incidence, severity (graded by NCI CTCAE v5.0), seriousness, timing and relationship to GTAEXS617 dosing.

  2. Module 1 Part A: To characterize the Dose Limiting Toxicities (DLTs) of GTAEXS617 as monotherapy [ Time Frame: Through patient study completion, an average of 6 months ]
    Incidence of dose limiting toxicities (DLTs) during Cycle 1 of treatment.

  3. Module 1 Part A: To establish the Recommended Phase 2 Dose (RP2D) of GTAEXS617 as monotherapy [ Time Frame: Through study completion for all patients in Module 1 Part A. Estimated 18 months. ]
    The RP2D will not exceed the maximum tolerated dose (MTD) if established.

  4. Module 1 Part B: To characterize the safety profile of GTAEXS617 in combination with selected Standard of Care (SoC) regimens [ Time Frame: Through patient study completion, an average of 6 months ]
    Incidence of treatment-emergent adverse events (TEAEs), characterised by type, incidence, severity (graded by NCI CTCAE v5.0), seriousness, timing and relationship to GTAEXS617 dosing.

  5. Module 1 Part B: To characterize the Dose Limiting Toxicities (DLTs) of GTAEXS617 in combination with selected Standard of Care (SoC) regimens [ Time Frame: Through patient study completion, an average of 6 months ]
    Incidence of dose limiting toxicities (DLTs) during Cycle 1 of treatment


Secondary Outcome Measures :
  1. Module 1 Part A: GTAEXS617 Maximum Plasma Concentration (Cmax) [ Time Frame: Through patient study completion, an average of 6 months ]
    Maximum Plasma Concentration (Cmax) when GTAEXS617 administered as monotherapy

  2. Module 1 Part A: GTAEXS617 Time Maximum Plasma Concentration (Tmax) [ Time Frame: Through patient study completion, an average of 6 months ]
    Time Maximum Plasma Concentration (Tmax) when GTAEXS617 administered as monotherapy

  3. Module 1 Part A: GTAEXS617 Area under Plasma Concentration Curve during 24 hour dosing interval (AUC 0-tau) [ Time Frame: Through patient study completion, an average of 6 months ]
    Area under Plasma Concentration Curve during 24 hour dosing interval (AUC 0-tau) when GTAEXS617 administered as monotherapy


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ECOG performance status 0-1
  • Life expectancy >3 months
  • One the following histologically or cytologically confirmed advanced solid tumors: head and neck squamous cell carcinoma, colorectal adenocarcinoma, pancreatic adenocarcinoma, NSCLC, breast carcinoma (HR+ and HER2- that has progressed to a prior treatment with CD4/CDK6 inhibitor), or ovarian epithelial carcinoma
  • Patients must have disease that is advanced (ie, surgery or radiotherapy are not considered to be potentially curative), recurrent, or metastatic following SoC treatments
  • Adequate hematological, liver, and renal function
  • Participant must have tumor lesion(s) or metastases amenable to biopsy, excluding bone metastases

Exclusion Criteria:

  • Active and clinically significant (CS) infection
  • Refractory nausea and/or vomiting, chronic gastrointestinal disease, or previous significant bowel resection, with CS sequelae that would preclude adequate absorption of GTAEXS617
  • Symptomatic central nervous system (CNS) malignancy or metastases
  • Concurrent active or previous malignancy
  • Prior organ or allogeneic stem-cell transplantation
  • Moderate or severe cardiovascular disease
  • Received anticancer therapy within 28 days or 5 half-lives (whichever is shorter) before the first dose of the study treatment
  • Received treatment with known strong inhibitors and or inducers of cytochrome P450 3A isoform subfamily (CYP3A) within 14 days or 5 half-lives before the first dose of study treatment
  • Received treatment with known inhibitors or inducers of P-glycoprotein (P-gp) or breast cancer resistance protein (BCRP) within 14 days or 5 half-lives before the first dose of study
  • Received treatment with known substrates of organic anion transporting peptide 1B3 (OATP1B3) or BCRP within 14 days or 5 half-lives before the first dose of study treatment
  • Unresolved or unstable serious toxic side-effects of prior chemotherapy or radiotherapy
  • Has had or is scheduled to have major surgery <28 days prior to the first dose of study treatment
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05985655


Contacts
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Contact: Holly Garratt +441865 818941 info@exscientia.co.uk
Contact: Eric Helmer +441865 818941 info@exscientia.co.uk

Locations
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Belgium
Clinique Universitaires Saint-Luc Recruiting
Brussels, Belgium
Principal Investigator: Rachel Galot         
CHU Sart Tilman Recruiting
Liège, Belgium
Principal Investigator: Laurence Lousberg         
United Kingdom
The Beatson West of Scotland Cancer Centre Recruiting
Glasgow, United Kingdom
Principal Investigator: Jeff Evans         
UCL Hospitals NHS Foundation Trust Recruiting
London, United Kingdom
Principal Investigator: Martin Forster         
The Christie NHS Foundation Trust Recruiting
Manchester, United Kingdom
Principal Investigator: Donna Graham         
Newcastle Upon Tyne NHS Foundation Trust Recruiting
Newcastle Upon Tyne, United Kingdom
Principal Investigator: Elizabeth Ruth Plummer         
Oxford University Hospitals NHS Foundation Trust Recruiting
Oxford, United Kingdom
Principal Investigator: Simon Lord         
Sponsors and Collaborators
Exscientia AI Limited
GT Apeiron LLC
More Information
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Responsible Party: Exscientia AI Limited
ClinicalTrials.gov Identifier: NCT05985655    
Other Study ID Numbers: GTAEXS617-001
First Posted: August 14, 2023    Key Record Dates
Last Update Posted: March 5, 2024
Last Verified: March 2024

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms