Study to Assess GTAEXS617 in Participants With Advanced Solid Tumors
Recruiting
Phase 1Phase 2Interventional Study
Head and Neck Squamous Cell Carcinoma (HNSCC)Pancreatic AdenocarcinomaNon-small Cell Lung Cancer (NSCLC)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 CarcinomaTriple Negative Breast Cancer (TNBC)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
230 (estimated)
Sponsor
Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc. · Industry
Who this trial is looking for
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
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…
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.
Contacts
Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc.
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.