Head and Neck Squamous Cell Carcinoma (HNSCC), Pancreatic Adenocarcinoma, Non-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 Carcinoma, Triple Negative Breast Cancer (TNBC)
Conditions
Keywords
Advanced Solid Tumor
Brief summary
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.
Interventions
DRUGGTAEXS617
Administered as specified in the treatment arm.
DRUGSoC
Participants will receive selected SoC regimen (fulvestrant, paclitaxel + bevacizumab, pegylated liposomal doxorubicin, or capecitabine) administered as specified in the treatment arm.
Sponsors
Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc.
Study design
Allocation
NON_RANDOMIZED
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 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/
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | 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 |
| 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 |
Countries
Belgium, United Kingdom, United States
Contacts
CONTACTExscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc.
STUDY_DIRECTORMedical Director
Exscientia AI Ltd.
Outcome results
None listed