A Study to Evaluate the Safety and Antitumor Activity of GS-1206 in Adults With Solid Tumors

Официальное название

A Phase 1 Study to Evaluate the Safety, Tolerability, and Antitumor Activity of GS-1206 in Adults With Solid Tumors

Обзор

The goal of this clinical study is to learn more about the study drug GS-1206, including its safety, tolerability, and antitumor activity in adult participants with solid tumors.

Вмешательства

• Препарат GS-1206
  Administered Orally

Первичные конечные точки

• Percentage of Participants Experiencing any Dose-limiting Toxicities (DLTs) [Срок оценки: First dose up to 21 days post first dose]
• Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAE) Based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v6.0. [Срок оценки: First dose date up to 30 days post last dose (Up to 3 years)]
• Percentage of Participants Experiencing Clinical Laboratory Abnormalities Based National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v6.0. [Срок оценки: First dose date up to 30 days post last dose (Up to 3 years)]

Вторичные конечные точки (9)

• Plasma Concentrations of GS-1206 and its Metabolites After Single Dose and Repeated Dose Administration [Срок оценки: Predose and postdose up to end of treatment (up to 2 years)]
• Pharmacokinetic (PK) Parameter: Cmax of GS-1206 and its Metabolites [Срок оценки: Up to 2 years]
• PK Parameter: Tmax of GS-1206 and its Metabolites [Срок оценки: Up to 2 years]
• PK Parameter: AUC0-24h of GS-1206 and its Metabolites [Срок оценки: Up to 2 years]
• Objective Response Rate (ORR) [Срок оценки: Up to 3 years]
• Duration of Response (DOR) [Срок оценки: Up to 3 years]
• Best Overall Response (BOR) [Срок оценки: Up to 3 years]
• Progression-Free Survival (PFS) [Срок оценки: Up to 3 years]
• Disease Control Rate (DCR) [Срок оценки: Up to 3 years]

Критерии участия

Критерии включения

• All individuals must have a tumor with protocol-specified mutation as determined by local health-authority approved test.
• For Part A (including backfill cohorts): Individuals with histologically confirmed advanced or metastatic solid tumors who have progressed following treatment in the advanced or metastatic setting known to confer clinical benefit, unless the individual refused, is intolerant to, or is not eligible for standard-of-care (SOC) treatment.
• For Part B dose expansion, individuals with protocol-specified tumor types will be enrolled.

Критерии исключения

• Use of any of the therapies listed below within the specified time frames:

• Investigational drugs (drugs not marketed for any indication) within 28 days prior to Cycle 1 Day 1.
• Anticancer biologic agent or immunotherapy within 28 days prior to Cycle 1 Day 1.
• Anticancer chemotherapy or targeted approved small molecule therapy within 21 days prior to Cycle 1 Day 1, or 42 days for nitrosoureas or mitomycin.
• Hormonal or other adjunctive therapy for cancers other than the cancer under evaluation in this study that started within 14 days prior to planned Cycle 1 Day 1 are not permitted. Exceptions: hormonal therapy, bisphosphonates, somatostatin analogues, and leuprolide are permitted if started at least 14 days prior to Cycle 1 Day 1.
• Major surgery (excluding minor procedures, eg, placement of vascular access, gastrointestinal/biliary stent, biopsy) within 28 days prior to Cycle 1 Day 1, and any toxicity or complications have recovered to Grade 1 or less.
• Radiation therapy within 21 days prior to Cycle 1 Day 1. Exception: limited (eg, pain palliation) radiation therapy is allowed if any radiation associated toxicity is resolved to Grade 1 or less, and the radiation is not administered to a target lesion.

Note: Other protocol defined 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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07703878 · GS-US-723-7652

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗