NCT05985655 Study to Assess GTAEXS617 in Participants With Advanced Solid Tumors
| NCT ID | NCT05985655 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc. |
| Condition | Head and Neck Squamous Cell Carcinoma (HNSCC) |
| Study Type | INTERVENTIONAL |
| Enrollment | 230 participants |
| Start Date | 2023-07-06 |
| Primary Completion | 2028-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 230 participants in total. It began in 2023-07-06 with a primary completion date of 2028-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Key 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 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. 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 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.
Contact & Investigator
Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc.
✉ clinicaltrials@recursionpharma.com📞 385-374-1724
Medical Director
STUDY DIRECTOR
Exscientia AI Ltd.
Frequently Asked Questions
Who can join the NCT05985655 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Head and Neck Squamous Cell Carcinoma (HNSCC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05985655 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05985655 currently recruiting?
Yes, NCT05985655 is actively recruiting participants. Contact the research team at clinicaltrials@recursionpharma.com for enrollment information.
Where is the NCT05985655 trial being conducted?
This trial is being conducted at Los Angeles, United States, Grand Rapids, United States, San Antonio, United States, West Valley City, United States and 9 additional locations.
Who is sponsoring the NCT05985655 clinical trial?
NCT05985655 is sponsored by Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc.. The principal investigator is Medical Director at Exscientia AI Ltd.. The trial plans to enroll 230 participants.