Study to Assess GTAEXS617 in Participants With Advanced Solid Tumors

Phase 1

Recruiting

• Conditions: Advanced Solid Tumor; Head and Neck Squamous Cell Carcinoma (HNSCC); Pancreatic Adenocarcinoma; Non-small Cell Lung Cancer (NSCLC); Breast Carcinoma; High-grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers (HGSOC); Hormone Receptor Positive [HR+] and Human Epidermal Growth Factor Receptor 2 Negative [HER2-] Breast Carcinoma
• Interventions: Drug: GTAEXS617; Drug: SoC

• Registration Number: NCT05985655
• Lead Sponsor: Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc.

Brief Summary

The primary purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and anti-tumor activity of GTAEXS617-001 in participants 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 Timeline

• Study Start: 2023-07-06
• Study First Submitted: 2023-07-25
• Study First Submitted QC: 2023-08-08
• Study First Posted: 2023-08-14
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-28
• Last Update Posted: 2025-09-05
• Primary Completion: 2028-01
• Study Completion: 2028-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 165

Inclusion Criteria

• Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
• Life expectancy > 3 months.
• One of the following histologically or cytologically confirmed advanced solid tumors: head and neck squamous cell carcinoma (HNSCC), pancreatic adenocarcinoma, non-small cell lung cancer (NSCLC), breast carcinoma (hormone receptor-positive [HR+] and Human Epidermal Growth Receptor 2 negative [HER2-] that has progressed to a prior treatment with Cluster of Differentiation 4 [CD4] / Cyclin-Dependent Kinase 6 [CDK6] inhibitor), or platinum-resistant high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancers (HGSOC).
• 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.
• Must have tumor lesion(s) or metastases amenable to biopsy, excluding bone metastases.

Key

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/moderate inhibitors and/or strong 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 treatment.
• 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.

Note: Other protocol Inclusion/Exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Phase 1: Dose Escalation Monotherapy	GTAEXS617	Participants will receive GTAEXS617 oral tablets in increasing doses.
Phase 2: Dose Expansion Monotherapy	GTAEXS617	Participants will receive GTAEXS617 oral tablets at Recommended Phase 2 Dose (RP2D).
Phase 1: Dose Escalation Combination Therapy	GTAEXS617	Participants will receive GTAEXS617 oral tablets in increasing doses in combination with standard of care (SoC) treatment.
Phase 1: Dose Escalation Combination Therapy	SoC	Participants will receive GTAEXS617 oral tablets in increasing doses in combination with standard of care (SoC) treatment.
Phase 2: Dose Expansion Combination Therapy	SoC	Participants will receive GTAEXS617 oral tablets at RP2D in combination with SoC treatment.
Phase 2: Dose Expansion Combination Therapy	GTAEXS617	Participants will receive GTAEXS617 oral tablets at RP2D in combination with SoC treatment.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Treatment Emergent Adverse Events (TEAEs)	Up to 2 years
Phase 1: Number of Participants With Dose Limiting Toxicities (DLTs)	Up to 28 days
Phase 2 : Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1	Up to 2 years

Secondary Outcome Measures

Name	Time	Method
Time Maximum Plasma Concentration (Tmax) of GTAEXS617	Predose up to 24 hours postdose
Area under Plasma Concentration Curve From Time Zero to the Last Quantifiable Concentration (AUC0-inf) of GTAEXS617	Predose up to 24 hours postdose
Phase 2: Disease Control Rate (DCR)	Up to 2 years
Maximum Plasma Concentration (Cmax) of GTAEXS617	Predose up to 24 hours postdose
Phase 2: Duration of Response (DOR)	Up to 2 years
Phase 2: Progression-Free Survival (PFS)	Up to 2 years

Trial Locations

Locations (12)

START Midwest; 🇺🇸 Grand Rapids, Michigan, United States

START San Antonio; 🇺🇸 San Antonio, Texas, United States

START Mountain Region; 🇺🇸 West Valley City, Utah, United States

GZA Ziekenhuizen - Campus Sint-Augustinus; 🇧🇪 Antwerp, Belgium

Institute Jules Bordet; 🇧🇪 Brussels, Belgium

Clinique Universitaires Saint-Luc; 🇧🇪 Brussels, Belgium

CHU Sart Tilman; 🇧🇪 Liège, Belgium

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

Scroll for more (2 remaining)