Study to Assess GTAEXS617 in Patients With Advanced Solid Tumors

Advanced Solid Tumor Clinical Trial

— ELUCIDATE  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05985655
• Other study ID #: GTAEXS617-001
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: July 6, 2023
• Est. completion date: May 2028

Study information

• Verified date: March 2024
• Source: Exscientia AI Limited
• Contact: Holly Garratt
• Phone: +441865 818941
• Email: info[@]exscientia.co.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 170
• Est. completion date: May 2028
• Est. primary completion date: January 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Neoplasms

Intervention

Drug:
• GTAEXS617
GTAEXS617 tablets daily

Locations

Country	Name	City	State
Belgium	Clinique Universitaires Saint-Luc	Brussels
Belgium	CHU Sart Tilman	Liège
United Kingdom	The Beatson West of Scotland Cancer Centre	Glasgow
United Kingdom	UCL Hospitals NHS Foundation Trust	London
United Kingdom	The Christie NHS Foundation Trust	Manchester
United Kingdom	Newcastle Upon Tyne NHS Foundation Trust	Newcastle Upon Tyne
United Kingdom	Oxford University Hospitals NHS Foundation Trust	Oxford

Sponsors (2)

Lead Sponsor	Collaborator
Exscientia AI Limited	GT Apeiron LLC

Countries where clinical trial is conducted

Belgium,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Module 1 Part A: To characterize the safety profile of GTAEXS617 as monotherapy	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.	Through patient study completion, an average of 6 months
Primary	Module 1 Part A: To characterize the Dose Limiting Toxicities (DLTs) of GTAEXS617 as monotherapy	Incidence of dose limiting toxicities (DLTs) during Cycle 1 of treatment.	Through patient study completion, an average of 6 months
Primary	Module 1 Part A: To establish the Recommended Phase 2 Dose (RP2D) of GTAEXS617 as monotherapy	The RP2D will not exceed the maximum tolerated dose (MTD) if established.	Through study completion for all patients in Module 1 Part A. Estimated 18 months.
Primary	Module 1 Part B: To characterize the safety profile of GTAEXS617 in combination with selected Standard of Care (SoC) regimens	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.	Through patient study completion, an average of 6 months
Primary	Module 1 Part B: To characterize the Dose Limiting Toxicities (DLTs) of GTAEXS617 in combination with selected Standard of Care (SoC) regimens	Incidence of dose limiting toxicities (DLTs) during Cycle 1 of treatment	Through patient study completion, an average of 6 months
Secondary	Module 1 Part A: GTAEXS617 Maximum Plasma Concentration (Cmax)	Maximum Plasma Concentration (Cmax) when GTAEXS617 administered as monotherapy	Through patient study completion, an average of 6 months
Secondary	Module 1 Part A: GTAEXS617 Time Maximum Plasma Concentration (Tmax)	Time Maximum Plasma Concentration (Tmax) when GTAEXS617 administered as monotherapy	Through patient study completion, an average of 6 months
Secondary	Module 1 Part A: GTAEXS617 Area under Plasma Concentration Curve during 24 hour dosing interval (AUC 0-tau)	Area under Plasma Concentration Curve during 24 hour dosing interval (AUC 0-tau) when GTAEXS617 administered as monotherapy	Through patient study completion, an average of 6 months