Gastric Cancer, Head and Neck Squamous Cell Carcinoma (HNSCC), Hepatic Cancer, High Grade Neuroendocrine Cancer, Non-small Cell Lung Cancer (NSCLC), Ovarian Cancer, Prostate Cancer, Renal Carcinoma (Clear and Non-clear Cell), Small Cell Carcinomas of Non-lung Origin, Small Cell Lung Cancer (SCLC), Solid Tumor, Triple-negative Breast Cancer (TNBC)
Conditions
Keywords
Solid Tumors, Small Cell Lung Cancer (SCLC), High grade neuroendocrine cancer, Small cell carcinomas of non-lung origin, Non-small cell lung cancer (NSCLC), Prostate cancer, Ovarian cancer, Renal carcinoma (clear and non-clear cell), Head and neck squamous cell carcinoma (HNSCC), Hepatic cancer, Gastric cancer, Triple-negative breast cancer (TNBC), LSD1 inhibitor, EXS74539, REC-4539
Brief summary
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.
Interventions
DRUGEXS74539
Oral administration
Sponsors
Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc.
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. * Histologically confirmed diagnosis of the following solid tumors: * SCLC * High grade neuroendocrine or small cell carcinomas of non-lung origin * Non-small cell lung cancer \[NSCLC\] * Prostate cancer * Ovarian cancer * Renal carcinoma \[clear and non-clear cell\] * Head and neck squamous cell carcinoma * Hepatic cancer * Gastric cancer * Triple-negative breast cancer \[TNBC\] * 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
* Any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the participant's safety or ability to participate in the study. * Symptomatic brain metastases, leptomeningeal metastases, or spinal cord compression due to disease. Participants with brain metastases must be clinically stable and off corticosteroids and anticonvulsants for ≥1 month prior to study treatment and not require any specific intervention for brain metastases. * Active and clinically significant infection requiring systemic antibacterial, antiviral, or antifungal therapy \<7 days of the first scheduled dose of the study treatment. * Significant cardiac abnormalities. * Major surgery within 28 days prior to the start of study treatment. Note: Other protocol-defined inclusion and
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | 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) |
| 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 |
Countries
United States
Contacts
CONTACTExscientia AI Ltd.
Outcome results
None listed