Study to Assess GTAEXS617 in Participants With Advanced Solid Tumors

NCT05985655 | Recruiting Phase 1 FDA Drug

• 1 other identifier: GTAEXS617-001
• Study Type: interventional
• Target: 230
• Locations: 3 countries
• Sites: 13

Brief Summary

The primary purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and anti-tumor activity of GTAEXS617 (REC-617) in participants with advanced solid tumors.

Conditions

Pancreatic Adenocarcinoma; Non-small Cell Lung Cancer (NSCLC); Head and Neck Squamous Cell Carcinoma (HNSCC); Platinum-resistant 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; Triple Negative Breast Cancer (TNBC)

Keywords

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• Phase 1: ORR as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

  Up to 2 years

• 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

• Duration of Response (DOR)

  Up to 2 years

Study Arms (4)

Phase 1: Dose Escalation Monotherapy

EXPERIMENTAL

Participants will receive GTAEXS617 oral tablets in increasing doses.

Drug: GTAEXS617

Phase 1: Dose Escalation Combination Therapy

EXPERIMENTAL

Participants will receive GTAEXS617 oral tablets in increasing doses in combination with standard of care (SoC) treatment.

Drug: GTAEXS617; Drug: SoC

Phase 2: Dose Expansion Monotherapy

EXPERIMENTAL

Participants will receive GTAEXS617 oral tablets at Recommended Phase 2 Dose (RP2D).

Drug: GTAEXS617

Phase 2: Dose Expansion Combination Therapy

EXPERIMENTAL

Participants will receive GTAEXS617 oral tablets at RP2D in combination with SoC treatment.

Drug: GTAEXS617; Drug: SoC

Interventions

SoC DRUG

Participants will receive selected SoC regimen (fulvestrant, paclitaxel + bevacizumab, pegylated liposomal doxorubicin, or capecitabine) administered as specified in the treatment arm.

Phase 1: Dose Escalation Combination Therapy; Phase 2: Dose Expansion Combination Therapy

GTAEXS617 DRUG

Administered as specified in the treatment arm.

Also known as: REC-617

Phase 1: Dose Escalation Combination Therapy; Phase 1: Dose Escalation Monotherapy; Phase 2: Dose Expansion Combination Therapy; Phase 2: Dose Expansion Monotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 Cyclin-Dependent Kinase 4 (CDK4)/ Cyclin-Dependent Kinase 6 \[CDK6\] inhibitor), or platinum-resistant high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancers (HGSOC), or triple negative breast cancer (TNBC).
• 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.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

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

Study Sites (13)

USC Norris Comprehensive Cancer Center

Los Angeles, California, 90089, United States

RECRUITING

START Midwest

Grand Rapids, Michigan, 49546, United States

RECRUITING

START San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

START Mountain Region

West Valley City, Utah, 84119, United States

RECRUITING

GZA Ziekenhuizen - Campus Sint-Augustinus

Antwerp, Belgium

RECRUITING

Clinique Universitaires Saint-Luc

Brussels, Belgium

RECRUITING

Institute Jules Bordet

Brussels, Belgium

RECRUITING

CHU Sart Tilman

Liège, Belgium

RECRUITING

The Beatson West of Scotland Cancer Centre

Glasgow, United Kingdom

RECRUITING

UCL Hospitals NHS Foundation Trust

London, United Kingdom

RECRUITING

The Christie NHS Foundation Trust

Manchester, United Kingdom

RECRUITING

Newcastle Upon Tyne NHS Foundation Trust

Newcastle upon Tyne, United Kingdom

RECRUITING

Oxford University Hospitals NHS Foundation Trust

Oxford, United Kingdom

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Carcinoma, Non-Small-Cell Lung; Fallopian Tube Neoplasms; Triple Negative Breast Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Fallopian Tube Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Breast Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Medical Director

  Exscientia AI Ltd.

  STUDY DIRECTOR

Central Study Contacts

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

CONTACT

385-374-1724; clinicaltrials@recursionpharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2023
• First Posted: August 14, 2023
• Study Start: July 6, 2023
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (4); GB (5); BE (4)