Clinical trial NCT05985655: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Advanced Solid Tumor
Lead sponsor: Exscientia AI Limited
Sponsor class: INDUSTRY
Collaborators: name: GT Apeiron LLC
First posted: 2023-08-14
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Module 1 Part A: To characterize the safety profile of GTAEXS617 as monotherapy
timeFrame: Through patient study completion, an average of 6 months
measure: Module 1 Part A: To characterize the Dose Limiting Toxicities (DLTs) of GTAEXS617 as monotherapy
timeFrame: Through patient study completion, an average of 6 months
measure: Module 1 Part A: To establish the Recommended Phase 2 Dose (RP2D) of GTAEXS617 as monotherapy
timeFrame: Through study completion for all patients in Module 1 Part A. Estimated 18 months.
measure: Module 1 Part B: To characterize the safety profile of GTAEXS617 in combination with selected Standard of Care (SoC) regimens
timeFrame: Through patient study completion, an average of 6 months
measure: Module 1 Part B: To characterize the Dose Limiting Toxicities (DLTs) of GTAEXS617 in combination with selected Standard of Care (SoC) regimens
timeFrame: Through patient study completion, an average of 6 months
Secondary outcomes:
measure: Module 1 Part A: GTAEXS617 Maximum Plasma Concentration (Cmax)
timeFrame: Through patient study completion, an average of 6 months
measure: Module 1 Part A: GTAEXS617 Time Maximum Plasma Concentration (Tmax)
timeFrame: Through patient study completion, an average of 6 months
measure: Module 1 Part A: GTAEXS617 Area under Plasma Concentration Curve during 24 hour dosing interval (AUC 0-tau)
timeFrame: Through patient study completion, an average of 6 months
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Clinique Universitaires Saint-Luc
city: Liège
country: Belgium
facility: CHU Sart Tilman
city: Glasgow
country: United Kingdom
facility: The Beatson West of Scotland Cancer Centre
city: London
country: United Kingdom
facility: UCL Hospitals NHS Foundation Trust
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust
city: Newcastle Upon Tyne
country: United Kingdom
facility: Newcastle Upon Tyne NHS Foundation Trust
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS Foundation Trust
Study officials:
References: