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

• ClinicalTrials.gov Identifier: NCT05985655
• Recruitment Status: Recruiting
• First Posted: August 14, 2023
• Last Update Posted: March 5, 2024
• Sponsor: Exscientia AI Limited
• Collaborator: GT Apeiron LLC
• Information provided by (Responsible Party): Exscientia AI Limited

Tracking Information

• First Submitted Date: July 25, 2023
• First Posted Date: August 14, 2023
• Last Update Posted Date: March 5, 2024
• Actual Study Start Date: July 6, 2023
• Estimated Primary Completion Date: January 2028 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 8, 2023)

• 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.
• 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.
• 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.
• 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.
• 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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 8, 2023)

• 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
• 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
• 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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study to Assess GTAEXS617 in Patients With Advanced Solid Tumors
• 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
• 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.
• 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 Type: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Advanced Solid Tumor

Intervention

Drug: GTAEXS617

GTAEXS617 tablets daily

Study Arms

Experimental: GTAEXS617

GTAEXS617 tablet for oral administration

Intervention: Drug: GTAEXS617

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: August 8, 2023): 170
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: May 2028
• Estimated Primary Completion Date: January 2028 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Holly Garratt; +441865 818941; info@exscientia.co.uk

Contact: Eric Helmer; +441865 818941; info@exscientia.co.uk

• Listed Location Countries: Belgium, United Kingdom

Administrative Information

• NCT Number: NCT05985655
• Other Study ID Numbers: GTAEXS617-001
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Exscientia AI Limited
• Original Responsible Party: Same as current
• Current Study Sponsor: Exscientia AI Limited
• Original Study Sponsor: Same as current
• Collaborators: GT Apeiron LLC
• Investigators: Not Provided
• PRS Account: Exscientia AI Limited
• Verification Date: March 2024