Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GTAEXS617 | Drug | Administered as specified in the treatment arm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol Inclusion/Exclusion criteria may apply.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc. | Contact | 385-374-1724 | clinicaltrials@recursionpharma.com |
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Exscientia AI Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USC Norris Comprehensive Cancer Center | Recruiting | Los Angeles | California | 90089 | United States | |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| SoC | Drug | Participants will receive selected SoC regimen (fulvestrant, paclitaxel + bevacizumab, pegylated liposomal doxorubicin, or capecitabine) administered as specified in the treatment arm. |
|
| 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 |
| Progression-Free Survival (PFS) | Up to 2 years |
| Disease Control Rate (DCR) | Up to 2 years |
| START Midwest |
| Recruiting |
| Grand Rapids |
| Michigan |
| 49546 |
| United States |
| START San Antonio | Recruiting | San Antonio | Texas | 78229 | United States |
| START Mountain Region | Recruiting | West Valley City | Utah | 84119 | United States |
| GZA Ziekenhuizen - Campus Sint-Augustinus | Recruiting | Antwerp | Belgium |
| Clinique Universitaires Saint-Luc | Recruiting | Brussels | Belgium |
|
| Institute Jules Bordet | Recruiting | Brussels | Belgium |
| CHU Sart Tilman | Recruiting | Liège | Belgium |
|
| The Beatson West of Scotland Cancer Centre | Recruiting | Glasgow | United Kingdom |
|
| UCL Hospitals NHS Foundation Trust | Recruiting | London | United Kingdom |
|
| The Christie NHS Foundation Trust | Recruiting | Manchester | United Kingdom |
|
| Newcastle Upon Tyne NHS Foundation Trust | Recruiting | Newcastle upon Tyne | United Kingdom |
|
| Oxford University Hospitals NHS Foundation Trust | Recruiting | Oxford | United Kingdom |
|
| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D005185 | Fallopian Tube Neoplasms |
| D064726 | Triple Negative Breast Neoplasms |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D005184 | Fallopian Tube Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D001943 | Breast Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided