Study to Assess GTAEXS617 in Patients With Advanced Solid Tumors
- Registration Number
- NCT05985655
- Lead Sponsor
- Exscientia AI Limited
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 170
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description GTAEXS617 GTAEXS617 GTAEXS617 tablet for oral administration
- Primary Outcome Measures
Name Time Method Module 1 Part A: To characterize the safety profile of GTAEXS617 as monotherapy 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 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 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 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 Through patient study completion, an average of 6 months Incidence of dose limiting toxicities (DLTs) during Cycle 1 of treatment
- Secondary Outcome Measures
Name Time Method Module 1 Part A: GTAEXS617 Maximum Plasma Concentration (Cmax) 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) 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) 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
Trial Locations
- Locations (7)
Clinique Universitaires Saint-Luc
🇧🇪Brussels, Belgium
The Christie NHS Foundation Trust
🇬🇧Manchester, United Kingdom
Oxford University Hospitals NHS Foundation Trust
🇬🇧Oxford, United Kingdom
CHU Sart Tilman
🇧🇪Liège, Belgium
The Beatson West of Scotland Cancer Centre
🇬🇧Glasgow, United Kingdom
UCL Hospitals NHS Foundation Trust
🇬🇧London, United Kingdom
Newcastle Upon Tyne NHS Foundation Trust
🇬🇧Newcastle Upon Tyne, United Kingdom