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The primary purpose of this study is to determine the safety, tolerability, and maximum tolerated dose (MTD) of EXS74539 (REC-4539) in participants with select solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EXS74539 | Experimental | EXS74539 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EXS74539 | Drug | Oral administration |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Up to 3 years | |
| Number of Participants with Dose-limiting Toxicity (DLT) | Up to 28 days | |
| Number of Participants with Dose Interruptions and Dose Modifications | Up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Concentration (Cmax) of EXS74539 | Cycle 1 Day 25 and at end of treatment (up to approximately 3 years) | |
| Time to Cmax (tmax) of EXS74539 | Cycle 1 Day 25 and at end of treatment (up to approximately 3 years) |
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Key Inclusion Criteria:
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
Histologically confirmed diagnosis of the following solid tumors:
Participant disease should have progressed, relapsed or the participants should have been intolerant to at least one prior standard systemic therapy for their respective underlying malignancy.
Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Key Exclusion Criteria:
Note: Other protocol-defined inclusion and exclusion criteria may apply.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Exscientia AI Ltd. | Contact | 385-374-1724 | clinicaltrials@recursion.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Start Lacn | Recruiting | Los Angeles | California | 90025 | United States | |
| START Dallas |
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| Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC[0-last]) of EXS74539 | Cycle 1 Day 1 through end of treatment (up to approximately 3 years) |
| Objective Response Rate (ORR) | Up to 3 years |
| Duration of Response (DoR) | Up to 3 years |
| Progression-free Survival (PFS) | Up to 3 years |
| Overall Survival (OS) | Up to 3 years |
| Recruiting |
| Fort Worth |
| Texas |
| 76104 |
| United States |
| START Mountain Region | Recruiting | West Valley City | Utah | 84119 | United States |
| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D011471 | Prostatic Neoplasms |
| D010051 | Ovarian Neoplasms |
| D002292 | Carcinoma, Renal Cell |
| D000072662 | Margins of Excision |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D008113 | Liver Neoplasms |
| D013274 | Stomach Neoplasms |
| D064726 | Triple Negative Breast Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D005833 | Genital Neoplasms, Female |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D065308 | Morphological and Microscopic Findings |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002294 | Carcinoma, Squamous Cell |
| D006258 | Head and Neck Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D005770 | Gastrointestinal Neoplasms |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D001943 | Breast Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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