A Study to Test the Safety and Effectiveness of GSK5764227, Alone or With Other Treatments, in Participants With Advanced Gastrointestinal Cancers That Cannot be Surgically Removed (EMBOLD PanGI-201)

Официальное название

A Phase1 b/2, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of GSK5764227 Alone and in Combination in Participants With Previously Treated Advanced Unresectable or Metastatic Gastrointestinal Solid Tumors

Обзор

This study will check how well a new medicine, Risvutatug rezetecan, (Ris-Rez, also known as GSK5764227) works, how safe it is and how the body handles it in participants all around the world with advanced inoperable or metastatic gastrointestinal cancer who have previously received treatment.

Вмешательства

• Биопрепарат Risvutatug Rezetecan
  Risvutatug Rezetecan will be administered
• Препарат Drug 1
  Drug 1 will be administered
• Препарат Drug 2
  Drug 2 will be administered
• Препарат Drug 3
  Drug 3 will be administered
• Препарат Drug 4
  Drug 4 will be administered

Первичные конечные точки

• Confirmed Objective Response Rate (ORR) [Срок оценки: Up to approximately 22 months]

Вторичные конечные точки (12)

• Unconfirmed ORR [Срок оценки: Up to approximately 37 months]
• Duration of Response (DoR) [Срок оценки: Up to approximately 37 months]
• Progression Free Survival (PFS) [Срок оценки: Up to approximately 37 months]
• Number of participants with AEs, serious adverse events (SAEs) and adverse events of special interest (AESIs) by severity [Срок оценки: Up to approximately 37 months]
• Number of participants with AEs leading to dose modifications, discontinuation of study interventions or death [Срок оценки: Up to approximately 37 months]
• Changes from baseline in vital signs: Temperature (degree Celsius) [Срок оценки: Baseline (Day 1) and up to approximately 37 months]
• Changes from baseline vital signs: Respiratory rate (breaths per minute) [Срок оценки: Baseline (Day 1) and up to approximately 37 months]
• Changes from baseline vital signs: Pulse rate (beats per minute) [Срок оценки: Baseline (Day 1) and up to approximately 37 months]
• Changes from baseline vital signs: Blood pressure [millimetres of mercury (mmHg) [Срок оценки: Baseline (Day 1) and up to approximately 37 months]
• Changes from baseline in hematology parameters: [White blood cell count (WBCs per microliter) [Срок оценки: Baseline (Day 1) and up to approximately 37 months]
• Changes from baseline in hematology parameters: [Haemoglobin (Hgb) (grams per deciliter) [Срок оценки: Baseline (Day 1) and up to approximately 37 months]
• Changes from baseline in hematology parameters:[Haematocrit (Proportion of red blood cells in blood) [Срок оценки: Baseline (Day 1) and up to approximately 37 months]

Критерии участия

Критерии включения

Participants are eligible to be included in the study only if all of the following criteria apply:

• Is at least 18 or the legal age of consent in the jurisdiction in which the study is taking place years of age at the time of signing the informed consent form (ICF).

CRC Cohort

• Has histologically confirmed unresectable, locally advanced or unresectable metastatic adenocarcinoma of the colon or rectum (histology defined by World Health Organization (WHO) classification).

PDAC Cohort

• Has histologically or cytologically confirmed unresectable, locally advanced or metastatic adenocarcinoma of the pancreas (histology defined by WHO classification).

All Cohorts

• Is willing to use adequate contraception.
• Is capable of giving signed informed consent, including compliance with the requirements and restrictions listed in the ICF and in the protocol.
• Has an ECOG performance status of 0 or 1.
• Has adequate organ function.

Критерии исключения

Participants are excluded from the study if any of the following criteria apply:

• Has a malignancy (except disease under study) that has progressed or required active treatment within the past 24 months except for basal cell or squamous cell carcinomas of the skin or in-situ carcinomas \[e.g., breast, cervix, bladder\] that have been resected with no evidence of disease.
• Has had any major surgery within 28 days prior to randomization or first dose of study intervention, depending on sub-cohort/cohort assignment
• Has any history of prior allogenic or autologous bone marrow transplant or other solid organ transplant.
• Has severe, uncontrolled or active cardiovascular disorders.
• Has serious or poorly controlled hypertension.
• Has clinically significant bleeding symptoms or significant bleeding tendency within 1 month prior to the first dose.
• Has untreated brain or Central nervous system (CNS) metastases or brain/CNS metastases that have progressed.
• Has evidence of current ILD/non-infectious pneumonitis or a prior history of ILD/non-infectious pneumonitis requiring high-dose glucocorticoids Or suspected ILD/non-infectious pneumonitis that cannot be ruled out by imaging.
• Has ongoing adverse reaction(s) from prior therapy that has(have) not recovered to Grade 1 or to the baseline status preceding prior therapy.
• Has received any prior therapy with an Antibody-drug conjugate (ADC) with a Topoisomerase-1 (TOPO1)-inhibitor payload.
• Is pregnant or breastfeeding.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 12 центров

• GSK Investigational Site — Los Alamitos
• GSK Investigational Site — Los Angeles
• GSK Investigational Site — Santa Monica
• GSK Investigational Site — Whittier
• GSK Investigational Site — Aurora
• GSK Investigational Site — New York
• GSK Investigational Site — New York
• GSK Investigational Site — Durham
• … и ещё 4 центра

Франция · 8 центров

• GSK Investigational Site — Dijon
• GSK Investigational Site — Marseille
• GSK Investigational Site — Paris
• GSK Investigational Site — Paris
• GSK Investigational Site — Paris
• GSK Investigational Site — Poitiers
• GSK Investigational Site — Rennes
• GSK Investigational Site — Villejuif

Испания · 8 центров

• GSK Investigational Site — Barcelona
• GSK Investigational Site — HebrOn
• GSK Investigational Site — Madrid
• GSK Investigational Site — Madrid
• GSK Investigational Site — Madrid
• GSK Investigational Site — Pamplona
• GSK Investigational Site — Santander
• GSK Investigational Site — Zaragoza

Япония · 6 центров

• GSK Investigational Site — Aichi
• GSK Investigational Site — Chiba
• GSK Investigational Site — Hokkaido
• GSK Investigational Site — Osaka
• GSK Investigational Site — Tokyo
• GSK Investigational Site — Tokyo

Германия · 5 центров

• GSK Investigational Site — Bochum
• GSK Investigational Site — Düsseldorf
• GSK Investigational Site — Frankfurt
• GSK Investigational Site — Lübeck
• GSK Investigational Site — München

Мексика · 5 центров

• GSK Investigational Site — Tuxtla Gutiérrez
• GSK Investigational Site — Cuernavaca
• GSK Investigational Site — Mexico City
• GSK Investigational Site — Mexico City
• GSK Investigational Site — San Pedro Garza García

Бельгия · 4 центра

• GSK Investigational Site — Bonheiden
• GSK Investigational Site — Brussels
• GSK Investigational Site — Leuven
• GSK Investigational Site — Roeselare

Канада · 4 центра

• GSK Investigational Site — Calgary
• GSK Investigational Site — Toronto
• GSK Investigational Site — Montreal
• GSK Investigational Site — Sherbrooke

Финляндия · 4 центра

• GSK Investigational Site — Helsinki
• GSK Investigational Site — Helsinki
• GSK Investigational Site — Kuopio
• GSK Investigational Site — Tampere

Италия · 4 центра

• GSK Investigational Site — Milan
• GSK Investigational Site — Milan
• GSK Investigational Site — Pisa
• GSK Investigational Site — Roma

Нидерланды · 4 центра

• GSK Investigational Site — Amsterdam
• GSK Investigational Site — Maastricht
• GSK Investigational Site — Rotterdam
• GSK Investigational Site — Utrecht

Швеция · 4 центра

Список центров уточняется — проверьте первичный протокол.

Бразилия · 3 центра

• GSK Investigational Site — Porto Alegre
• GSK Investigational Site — São Paulo
• GSK Investigational Site — Teresina

Норвегия · 3 центра

• GSK Investigational Site — Lrenskog
• GSK Investigational Site — Oslo
• GSK Investigational Site — Stavanger

Польша · 3 центра

• GSK Investigational Site — Brzozów
• GSK Investigational Site — Koszalin
• GSK Investigational Site — Warsaw

South Korea · 3 центра

• GSK Investigational Site — Seoul
• GSK Investigational Site — Seoul
• GSK Investigational Site — Seoul

Австралия · 2 центра

• GSK Investigational Site — Heidelberg
• GSK Investigational Site — Melbourne

Panama · 2 центра

• GSK Investigational Site — La Villa de Los Santos
• GSK Investigational Site — Punta Pacifica Panama City Panama

Великобритания · 1 центр

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06885034 · 223675 · 2025-520672-26-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗