Study To Assess GTAEXS617 In Participants With Advanced Solid Tumors

Study Overview

Study to Assess GTAEXS617 in Participants With Advanced Solid Tumors

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.

N/A

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

DRUG: GTAEXS617
DRUG: SoC

GTAEXS617-001

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2023-07-25	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-08-28
First Submitted that Met QC Criteria 2023-08-08	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2025-09-05
First Posted (ESTIMATED) 2023-08-14	Results First Posted N/A	Last Verified 2025-08

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Sequential

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Phase 1: Dose Escalation Monotherapy Participants will receive GTAEXS617 oral tablets in increasing doses.	DRUG: GTAEXS617 Administered as specified in the treatment arm.
EXPERIMENTAL: Phase 1: Dose Escalation Combination Therapy Participants will receive GTAEXS617 oral tablets in increasing doses in combination with standard of care (SoC) treatment.	DRUG: GTAEXS617 Administered as specified in the treatment arm. DRUG: SoC Participants will receive either fulvestrant (breast cancers) or paclitaxel + bevacizumab (HGSOC) as specified in the treatment arm.
EXPERIMENTAL: Phase 2: Dose Expansion Monotherapy Participants will receive GTAEXS617 oral tablets at Recommended Phase 2 Dose (RP2D).	DRUG: GTAEXS617 Administered as specified in the treatment arm.
EXPERIMENTAL: Phase 2: Dose Expansion Combination Therapy Participants will receive GTAEXS617 oral tablets at RP2D in combination with SoC treatment.	DRUG: GTAEXS617 Administered as specified in the treatment arm. DRUG: SoC Participants will receive either fulvestrant (breast cancers) or paclitaxel + bevacizumab (HGSOC) as specified in the treatment arm.

Primary Outcome Measures	Measure Description	Time Frame
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	Measure Description	Time Frame
Maximum Plasma Concentration (Cmax) of GTAEXS617		Predose up to 24 hours postdose
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: Duration of Response (DOR)		Up to 2 years
Phase 2: Progression-Free Survival (PFS)		Up to 2 years
Phase 2: Disease Control Rate (DCR)		Up to 2 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc.

Phone Number: 385-374-1724

Email: clinicaltrials@recursionpharma.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_DIRECTOR: Medical Director, Exscientia AI Ltd.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record