Study to Assess GTAEXS617 in Participants With Advanced Solid Tumors

Официальное название

A Phase 1/2 Open-label Multicenter Study to Assess the Safety, Pharmacokinetics, and Anti-tumor Activity of GTAEXS617 in Patients With Advanced Solid Tumors

Обзор

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.

Вмешательства

• Препарат GTAEXS617
  Administered as specified in the treatment arm.
• Препарат SoC
  Participants will receive selected SoC regimen (fulvestrant, paclitaxel + bevacizumab, pegylated liposomal doxorubicin, or capecitabine) administered as specified in the treatment arm.

Первичные конечные точки

• Number of Participants With Treatment Emergent Adverse Events (TEAEs) [Срок оценки: Up to 2 years]
• Phase 1: Number of Participants With Dose Limiting Toxicities (DLTs) [Срок оценки: Up to 28 days]
• Phase 2 : Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 [Срок оценки: Up to 2 years]

Вторичные конечные точки (7)

• Phase 1: ORR as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 [Срок оценки: Up to 2 years]
• Maximum Plasma Concentration (Cmax) of GTAEXS617 [Срок оценки: Predose up to 24 hours postdose]
• Time Maximum Plasma Concentration (Tmax) of GTAEXS617 [Срок оценки: Predose up to 24 hours postdose]
• Area under Plasma Concentration Curve From Time Zero to the Last Quantifiable Concentration (AUC0-inf) of GTAEXS617 [Срок оценки: Predose up to 24 hours postdose]
• Duration of Response (DOR) [Срок оценки: Up to 2 years]
• Progression-Free Survival (PFS) [Срок оценки: Up to 2 years]
• Disease Control Rate (DCR) [Срок оценки: Up to 2 years]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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/Exclusion criteria may apply.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Великобритания · 5 центров

• The Beatson West of Scotland Cancer Centre — Glasgow
• UCL Hospitals NHS Foundation Trust — London
• The Christie NHS Foundation Trust — Manchester
• Newcastle Upon Tyne NHS Foundation Trust — Newcastle upon Tyne
• Oxford University Hospitals NHS Foundation Trust — Oxford

США · 4 центра

• USC Norris Comprehensive Cancer Center — Los Angeles
• START Midwest — Grand Rapids
• START San Antonio — San Antonio
• START Mountain Region — West Valley City

Бельгия · 4 центра

• GZA Ziekenhuizen - Campus Sint-Augustinus — Antwerp
• Clinique Universitaires Saint-Luc — Brussels
• Institute Jules Bordet — Brussels
• CHU Sart Tilman — Liège

Идентификаторы

NCT: NCT05985655 · GTAEXS617-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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