RECRUITING

Study to Assess GTAEXS617 in Participants With Advanced Solid Tumors

Talk to us

Conditions

Advanced Solid TumorHead and Neck Squamous Cell Carcinoma (HNSCC)Pancreatic AdenocarcinomaNon-small Cell Lung Cancer (NSCLC)Breast CarcinomaHigh-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

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2023-07-06
Study Completion:2028-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05985655

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:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
  2. * Life expectancy \> 3 months.
  3. * 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).
  4. * Must have disease that is advanced (ie, surgery or radiotherapy are not considered to be potentially curative), recurrent, or metastatic following SoC treatments.
  5. * Adequate hematological, liver, and renal function.
  6. * Must have tumor lesion(s) or metastases amenable to biopsy, excluding bone metastases.
  1. * Active and clinically significant (CS) infection.
  2. * Refractory nausea and/or vomiting, chronic gastrointestinal disease, or previous significant bowel resection, with CS sequelae that would preclude adequate absorption of GTAEXS617.
  3. * Symptomatic central nervous system (CNS) malignancy or metastases.
  4. * Concurrent active or previous malignancy.
  5. * Prior organ or allogeneic stem-cell transplantation.
  6. * Moderate or severe cardiovascular disease.
  7. * Received anticancer therapy within 28 days or 5 half-lives (whichever is shorter) before the first dose of the study treatment.
  8. * 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.
  9. * 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.
  10. * 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.
  11. * Unresolved or unstable serious toxic side-effects of prior chemotherapy or radiotherapy
  12. * Has had or is scheduled to have major surgery \<28 days prior to the first dose of study treatment.

Contacts and Locations

Study Contact

Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc.
CONTACT
385-374-1724
clinicaltrials@recursionpharma.com

Principal Investigator

Medical Director
STUDY_DIRECTOR
Exscientia AI Ltd.

Study Locations (Sites)

START Midwest
Grand Rapids, Michigan, 49546
United States
START San Antonio
San Antonio, Texas, 78229
United States
START Mountain Region
West Valley City, Utah, 84119
United States

Collaborators and Investigators

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

  • Medical Director, STUDY_DIRECTOR, Exscientia AI Ltd.

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

Study Start Date2023-07-06
Study Completion Date2028-05

Study Record Updates

Study Start Date2023-07-06
Study Completion Date2028-05

Terms related to this study

Additional Relevant MeSH Terms

  • 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