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Also known as REC-617
GTAEXS617 · 1 trial · 6 indications
| Arm | Type | Description |
|---|---|---|
| Phase 1: Dose Escalation Monotherapy | EXPERIMENTAL | Participants will receive GTAEXS617 oral tablets in increasing doses. |
| Phase 1: Dose Escalation Combination Therapy | EXPERIMENTAL | Participants will receive GTAEXS617 oral tablets in increasing doses in combination with standard of care (SoC) treatment. |
| Phase 2: Dose Expansion Monotherapy | EXPERIMENTAL | Participants will receive GTAEXS617 oral tablets at Recommended Phase 2 Dose (RP2D). |
| Phase 2: Dose Expansion Combination Therapy | EXPERIMENTAL | Participants will receive GTAEXS617 oral tablets at RP2D in combination with SoC treatment. |
| Name | Type | Description |
|---|---|---|
| GTAEXS617 | DRUG | Administered as specified in the treatment arm. |
| SoC | DRUG | Participants will receive selected SoC regimen (fulvestrant, paclitaxel + bevacizumab, pegylated liposomal doxorubicin, or capecitabine) administered as specified in the treatment arm. |
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...
GTAEXS617 is an investigational small molecule being studied in adults with advanced solid tumors, including head and neck squamous cell carcinoma (HNSCC). The Phase 1 trial also enrolls patients with pancreatic adenocarcinoma, non-small cell lung cancer, platinum-resistant high-grade epithelial ovarian cancer, HR+/HER2- breast carcinoma, and triple negative breast cancer.
GTAEXS617 targets CDK7, a cyclin-dependent kinase involved in cell cycle regulation and transcription. By inhibiting CDK7, the drug is designed to interfere with processes that cancer cells rely on to grow and divide. It is being developed as an oral small molecule for advanced solid tumors.
GTAEXS617 is being developed by Recursion Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker RXRX. Recursion is the sponsor of the clinical program evaluating the compound in advanced solid tumors, including head and neck squamous cell carcinoma.
GTAEXS617 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The ongoing Phase 1 study is enrolling adults with advanced solid tumors to evaluate the compound, and no trials of GTAEXS617 have been completed to date.
GTAEXS617 is being evaluated in one active clinical trial, NCT05985655, titled a study to assess GTAEXS617 in participants with advanced solid tumors. The Phase 1 trial is currently recruiting, has an estimated enrollment of 230 participants, and is running in the United States, Belgium, and the United Kingdom.
Yes. The Phase 1 trial of GTAEXS617, NCT05985655, is biomarker selected, meaning enrollment is guided by biomarker criteria. The study is a controlled trial in adults 18 years and older with advanced solid tumors, including head and neck squamous cell carcinoma, and it is currently recruiting participants.