Study to Assess GTAEXS617 in Patients With Advanced Solid Tumors

• Status: Recruiting
• Trial end date: 2028-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Exscientia AI Limited
• Collaborator: GT Apeiron LLC

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