A Study to Evaluate Safety, Pharmacokinetics, and Activity of GDC-7035 as a Single Agent and in Combination in Patients With Advanced Solid Tumors

Официальное название

A Phase I/II Dose-Escalation and Expansion Study Evaluating the Safety, Pharmacokinetics, and Activity of GDC-7035 as a Single Agent and in Combination With Other Anti-Cancer Therapies in Patients With Advanced Solid Tumors With a KRAS G12D Mutation

Обзор

This is a first-in-human Phase I/II, open-label, multicenter, dose-escalation and expansion study designed to evaluate the safety, pharmacokinetics, and preliminary activity of GDC-7035 as a single agent and in combination with other anti-cancer therapies in participants with advanced or metastatic solid tumors that harbor the KRAS G12D mutation.

Вмешательства

• Препарат Phase I Arm A
  Dose escalation and expansion arm, with protocol-defined dose(s) of GDC-7035
• Препарат Phase I Arm B
  Dose escalation and expansion arm, with protocol-defined dose(s) of GDC-7035 in combination with other anti-cancer therapies

Первичные конечные точки

• Percentage of Participants with Adverse Events, with Severity Determined According to the CTCAE v5.0 Grading Scale [Срок оценки: 4 Years]
• Percentage of Participants with Dose Limiting Toxicity [Срок оценки: 4 Years]

Вторичные конечные точки (7)

• Plasma Concentrations of GDC-7035 at Specified Timepoints [Срок оценки: 4 Years]
• Blood Concentrations of GDC-7035 at Specified Timepoints [Срок оценки: 4 Years]
• Plasma Concentrations at Specified Timepoints of GDC-7035 Administered in the Fasted State or with a Standardized High-Fat Meal [Срок оценки: 4 Years]
• Blood Concentrations at Specified Timepoints of GDC-7035 Administered in the Fasted State or with a Standardized High-Fat Meal [Срок оценки: 4 Years]
• Objective Response Rate Among Participants [Срок оценки: 4 Years]
• Duration of Response Among Participants [Срок оценки: 4 Years]
• Median Progression Free Survival Time Among Participants [Срок оценки: 4 Years]

Критерии участия

Критерии включения

• Histologically documented advanced or metastatic solid tumor with KRAS G12D mutation
• Agreement to adhere to the contraception requirements described in the protocol for participants of childbearing potential and participants who produce sperm

Критерии исключения

• Malabsorption or other condition that would interfere with enteral absorption
• Active brain metastases
• Clinically significant cardiovascular dysfunction or liver disease

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

США · 12 центров

• UC San Diego Moores Cancer Center — La Jolla
• Sarah Cannon Research Institute at HealthONE — Denver
• Yale Cancer Center — New Haven
• Florida Cancer Specialist-Lake Mary — Lake Mary
• University of Illinois — Chicago
• Dana Farber Cancer Institute — Boston
• START - Midwest - EDOS — Grand Rapids
• Montefiore Einstein Cancer Center — The Bronx
• … и ещё 4 центра

Испания · 6 центров

• Instituto de Investigacion Oncologica Vall dHebron (VHIO) - EPON — Barcelona
• Hospital Universitario 12 de Octubre — Madrid
• START Madrid_Hospital Universitario HM Sanchinarro_CIOCC — Madrid
• Hospital Universitario Virgen de la Victoria — Málaga
• Hospital Universitario Virgen del Rocio - PPDS — Seville
• Hospital Clinico Universitario de Valencia — Valencia

Израиль · 4 центра

• Rambam Health Care Campus — Haifa
• Hadassah University Hospital - Ein Kerem — Jerusalem
• The Chaim Sheba Medical Center — Ramat Gan
• Tel Aviv Sourasky Medical Center PPDS — Tel Aviv

South Korea · 4 центра

• Seoul National University Bundang Hospital — Seongnam
• Asan Medical Center. — Seoul
• Seoul National University Hospital — Seoul
• Severance Hospital, Yonsei University Health System — Seoul

Великобритания · 4 центра

• Western General Hospital;Edinburgh Cancer Center — Edinburgh
• NIHR UCLH Clinical Research Facility — London
• The Christie — Manchester
• Royal Marsden Hospital - Surrey — Sutton

Австралия · 3 центра

• St Vincent's Hospital Sydney — Darlinghurst
• Slade Health Inward goods — Mount Kuring-Gai
• Peter Maccallum Cancer Centre — Parkville

Канада · 3 центра

• British Columbia Cancer Agency — Vancouver
• Princess Margaret Cancer Centre — Toronto
• Sir Mortimer B Davis Jewish General Hospital — Montreal

Франция · 3 центра

• Gustave Roussy — Villejuif
• Institut Bergonie — Bordeaux
• Centre Georges Francois Leclerc — Dijon

Сингапур · 2 центра

• National University Hospital — Singapore
• National Cancer Centre — Singapore

Идентификаторы

NCT: NCT06619587 · GO45416

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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