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Um estudo de GSK5733584 em combinação com terapias anticâncer para tumores sólidos avançados

30 de outubro de 2026 atualizado por: GlaxoSmithKline

Um estudo randomizado de fase I/II de Multi-Coorte para avaliar a segurança, tolerabilidade, farmacocinética e atividade clínica de GSK5733584 em combinação com agentes anticâncer em participantes com tumores sólidos avançados

Advanced solid tumors are cancers that have spread to other parts of the body. While many treatments exist, most people become resistant to them, and the cancer returns. Researchers are developing new treatments that combine different medicines for those who do not respond to single medicine. This study is looking at how safe and tolerable Mocertatug Rezetecan (Mo-Rez) is, how the body handles it, and how well it works when used with other cancer medicines. The study will include participants with advanced solid tumors who have either not responded to standard treatments or cannot tolerate them or have no available effective treatment.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

305

Estágio

  • Fase 2
  • Fase 1

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Locais de estudo

  • Alemanha
      • Cologne, Alemanha, 50931
        • Recrutamento
        • GSK Investigational Site
        • Contato:
        • Contato:
        • Investigador principal:
          • Christian Maurer
      • Leipzig, Alemanha, 04103
        • Recrutamento
        • GSK Investigational Site
        • Contato:
        • Contato:
        • Investigador principal:
          • Gertraud Stocker
    • Bavaria
      • München, Bavaria, Alemanha, 81377
        • Recrutamento
        • GSK Investigational Site
        • Contato:
        • Contato:
        • Investigador principal:
          • Lena Weiss
    • Rhineland-Palatinate
      • Mainz, Rhineland-Palatinate, Alemanha, 55131
        • Recrutamento
        • GSK Investigational Site
        • Contato:
        • Contato:
        • Investigador principal:
          • Alexander Desuki
  • Argentina
      • Buenos Aires, Argentina, C1181ACH
        • Recrutamento
        • GSK Investigational Site
        • Contato:
        • Contato:
        • Investigador principal:
          • Ventura Simonovich
      • Buenos Aires, Argentina, C1280AEB
        • Recrutamento
        • GSK Investigational Site
        • Contato:
        • Contato:
        • Investigador principal:
          • Karina Vera
      • CABA, Argentina, C1187
        • Recrutamento
        • GSK Investigational Site
        • Contato:
        • Contato:
        • Investigador principal:
          • Gabriela Cinat
      • Viedma, Argentina, R8500ACE
        • Recrutamento
        • GSK Investigational Site
        • Contato:
        • Contato:
        • Investigador principal:
          • Rubén Kowalyszyn
  • Austrália
    • New South Wales
      • Liverpool, New South Wales, Austrália, 2170
        • Recrutamento
        • GSK Investigational Site
        • Contato:
        • Contato:
        • Investigador principal:
          • Kate Wilkinson
      • Wollongong, New South Wales, Austrália, 2500
        • Recrutamento
        • GSK Investigational Site
        • Contato:
        • Contato:
        • Investigador principal:
          • Udit Nindra
  • Brasil
      • Barretos, Brasil, 14784-400
        • Recrutamento
        • GSK Investigational Site
        • Contato:
        • Contato:
        • Investigador principal:
          • Ana Suellen Barroso Carneiro
      • Goiânia, Brasil, 74605-070
        • Recrutamento
        • GSK Investigational Site
        • Contato:
        • Contato:
        • Investigador principal:
          • Ruffo de Freitas Junior
      • Natal, Brasil, 59075-740
        • Recrutamento
        • GSK Investigational Site
        • Contato:
        • Contato:
        • Investigador principal:
          • Andrea Juliana Pereira Santana Gomes
      • Porto Alegre, Brasil, 90020-090
        • Recrutamento
        • GSK Investigational Site
        • Investigador principal:
          • Katsuki Tiscoski
        • Contato:
        • Contato:
      • São Paulo, Brasil, 01246-000
        • Recrutamento
        • GSK Investigational Site
        • Contato:
        • Contato:
        • Investigador principal:
          • Maria Del Pilar Diz
      • Vitória, Brasil, 29043-260
        • Recrutamento
        • GSK Investigational Site
        • Contato:
        • Contato:
        • Investigador principal:
          • GLAUCIO BERTOLLO
  • Bélgica
      • Brussels, Bélgica, 1200
        • Recrutamento
        • GSK Investigational Site
        • Contato:
        • Contato:
        • Investigador principal:
          • Jean Francois Baurain
      • Ghent, Bélgica, 9000
        • Recrutamento
        • GSK Investigational Site
        • Investigador principal:
          • Sylvie Rottey
        • Contato:
        • Contato:
      • Leuven, Bélgica, 3000
        • Recrutamento
        • GSK Investigational Site
        • Investigador principal:
          • Toon van Gorp
        • Contato:
        • Contato:
      • Liège, Bélgica, 4000
        • Recrutamento
        • GSK Investigational Site
        • Contato:
        • Contato:
        • Investigador principal:
          • Christine Gennigens
  • Canadá
    • British Columbia
      • Vancouver, British Columbia, Canadá, V5Z 4E6
        • Recrutamento
        • GSK Investigational Site
        • Contato:
        • Contato:
        • Investigador principal:
          • Yvette Drew
    • Ontario
      • Toronto, Ontario, Canadá, M5G 2M9
        • Recrutamento
        • GSK Investigational Site
        • Contato:
        • Contato:
        • Investigador principal:
          • Stephanie Lheureux
    • Quebec
      • Montreal, Quebec, Canadá, H4A 3J1
        • Recrutamento
        • GSK Investigational Site
        • Contato:
        • Contato:
        • Investigador principal:
          • Xing Zeng
      • Montreal, Quebec, Canadá, H2X 0A9
        • Recrutamento
        • GSK Investigational Site
        • Contato:
        • Investigador principal:
          • Diane Provencher
        • Contato:
  • Coréia do Sul
      • Seoul, Coréia do Sul, 05505
        • Recrutamento
        • GSK Investigational Site
        • Contato:
        • Contato:
        • Investigador principal:
          • jeong yeol park
      • Seoul, Coréia do Sul, 135-710
        • Recrutamento
        • GSK Investigational Site
        • Contato:
        • Contato:
        • Investigador principal:
          • Yooyoung Lee
      • Seoul, Coréia do Sul, 120-752
        • Recrutamento
        • GSK Investigational Site
        • Contato:
        • Contato:
        • Investigador principal:
          • Jung-Yun Lee
  • Dinamarca
      • Herlev, Dinamarca
        • Recrutamento
        • GSK Investigational Site
        • Contato:
        • Contato:
        • Investigador principal:
          • Rikke Eefsen
    • Capital Region
      • København Ø, Capital Region, Dinamarca, 2100
        • Recrutamento
        • GSK Investigational Site
        • Investigador principal:
          • Kristoffer Rohrberg
        • Contato:
        • Contato:
  • Espanha
      • A Coruña, Espanha, 15009
        • Recrutamento
        • GSK Investigational Site
        • Contato:
        • Contato:
        • Investigador principal:
          • María Quindos Varela
      • Barcelona, Espanha, 08035
        • Recrutamento
        • GSK Investigational Site
        • Contato:
        • Contato:
        • Investigador principal:
          • Roberta Mazzeo
      • Barcelona, Espanha, 08036
        • Recrutamento
        • GSK Investigational Site
        • Investigador principal:
          • Lydia Gaba
        • Contato:
        • Contato:
      • Barcelona, Espanha, 08023
        • Recrutamento
        • GSK Investigational Site
        • Investigador principal:
          • Tatiana Hernandez
        • Contato:
        • Contato:
      • Madrid, Espanha, 28041
        • Recrutamento
        • GSK Investigational Site
        • Contato:
        • Contato:
        • Investigador principal:
          • Luis Manso Sánchez
      • Madrid, Espanha, 28050
        • Recrutamento
        • GSK Investigational Site
        • Contato:
        • Contato:
        • Investigador principal:
          • Ramón Yarza
      • Madrid, Espanha, 28033
        • Recrutamento
        • GSK Investigational Site
        • Contato:
        • Contato:
        • Investigador principal:
          • Raúl Márquez Vázquez
      • Málaga, Espanha, 29010
        • Recrutamento
        • GSK Investigational Site
        • Contato:
        • Contato:
        • Investigador principal:
          • Javier García Corbacho
      • Valencia, Espanha, 46009
        • Recrutamento
        • GSK Investigational Site
        • Contato:
        • Contato:
        • Investigador principal:
          • Ignacio Romero Noguera
      • Zaragoza, Espanha, 50009
        • Recrutamento
        • GSK Investigational Site
        • Contato:
        • Contato:
        • Investigador principal:
          • EUGENIA ORTEGA
  • Estados Unidos
    • California
      • La Jolla, California, Estados Unidos, 92093
        • Recrutamento
        • GSK Investigational Site
        • Contato:
        • Contato:
        • Investigador principal:
          • Ramez Eskander
    • Colorado
      • Aurora, Colorado, Estados Unidos, 80045-2517
        • Recrutamento
        • GSK Investigational Site
        • Investigador principal:
          • Bradley Corr
        • Contato:
        • Contato:
    • New York
      • Rochester, New York, Estados Unidos, 55905-0001
        • Recrutamento
        • GSK Investigational Site
        • Contato:
        • Contato:
        • Investigador principal:
          • Grace Choong
    • North Carolina
      • Durham, North Carolina, Estados Unidos, 27710
        • Recrutamento
        • GSK Investigational Site
        • Investigador principal:
          • Angeles Secord
        • Contato:
        • Contato:
    • Ohio
      • Columbus, Ohio, Estados Unidos, 43210-1240
        • Recrutamento
        • GSK Investigational Site
        • Investigador principal:
          • John Hays
        • Contato:
        • Contato:
  • Finlândia
      • Helsinki, Finlândia, 00029
        • Recrutamento
        • GSK Investigational Site
        • Contato:
        • Contato:
        • Investigador principal:
          • Katriina Jalkanen
      • Tampere, Finlândia, 33520
        • Recrutamento
        • GSK Investigational Site
        • Contato:
        • Contato:
        • Investigador principal:
          • Annika Auranen
  • França
      • Lyon, França, 69373
        • Recrutamento
        • GSK Investigational Site
        • Contato:
        • Contato:
        • Investigador principal:
          • Isabelle Ray Coquard
      • Marseille, França, 13273
        • Recrutamento
        • GSK Investigational Site
        • Contato:
        • Contato:
        • Investigador principal:
          • Renaud Sabatier
      • Montpellier, França, 34298
        • Recrutamento
        • GSK Investigational Site
        • Investigador principal:
          • Diego Tosi
        • Contato:
        • Contato:
      • Pierre-Bénite, França, 69495
        • Recrutamento
        • GSK Investigational Site
        • Contato:
        • Contato:
        • Investigador principal:
          • Benoit YOU
      • Villejuif, França, 94805
        • Recrutamento
        • GSK Investigational Site
        • Investigador principal:
          • Yohann Loriot
        • Contato:
        • Contato:
  • Grécia
      • Athens, Grécia, 11528
        • Recrutamento
        • GSK Investigational Site
        • Investigador principal:
          • Michalis Liontos
        • Contato:
        • Contato:
      • Athens, Grécia, 12462
        • Recrutamento
        • GSK Investigational Site
        • Contato:
        • Contato:
        • Investigador principal:
          • Amanda Psyrri
      • Pylaia Thessaloniki, Grécia, 570 01
        • Recrutamento
        • GSK Investigational Site
        • Contato:
        • Contato:
        • Investigador principal:
          • Sofia Baka
    • Central Macedonia
      • Panórama, Central Macedonia, Grécia, 552 36
        • Recrutamento
        • GSK Investigational Site
        • Contato:
        • Contato:
        • Investigador principal:
          • Eleni Fountzila
  • Holanda
      • Amsterdam, Holanda, 1066 CX
        • Recrutamento
        • GSK Investigational Site
        • Contato:
        • Contato:
        • Investigador principal:
          • Tim Schutte
      • Amsterdam, Holanda, 1081 HV
        • Recrutamento
        • GSK Investigational Site
        • Investigador principal:
          • Catharina W. Menke - van der Houven van Oordt
        • Contato:
        • Contato:
      • Rotterdam, Holanda, 3015 GD
        • Recrutamento
        • GSK Investigational Site
        • Contato:
        • Contato:
        • Investigador principal:
          • Sander Bins
  • Itália
      • Milan, Itália, 20141
        • Recrutamento
        • GSK Investigational Site
        • Contato:
        • Contato:
        • Investigador principal:
          • Giuseppe Curigliano
      • Naples, Itália, 80131
        • Recrutamento
        • GSK Investigational Site
        • Investigador principal:
          • Adriano Gravina
        • Contato:
        • Contato:
      • Padova, Itália, 35128
        • Recrutamento
        • GSK Investigational Site
        • Contato:
        • Contato:
        • Investigador principal:
          • Valentina Guarneri
    • MI
      • Milan, MI, Itália, 20159
        • Recrutamento
        • GSK Investigational Site
        • Contato:
        • Contato:
        • Investigador principal:
          • Domenica Lorusso
    • RM
      • Roma, RM, Itália, 00168
        • Recrutamento
        • GSK Investigational Site
        • Investigador principal:
          • Vanda Salutari
        • Contato:
        • Contato:
  • Japão
      • Chiba, Japão, 277-8577
        • Recrutamento
        • GSK Investigational Site
        • Contato:
        • Contato:
        • Investigador principal:
          • Shigehiro Koganemaru
      • Fukuoka, Japão, 811-1395
        • Recrutamento
        • GSK Investigational Site
        • Contato:
        • Contato:
        • Investigador principal:
          • Kazuya Ariyoshi
      • Tokyo, Japão, 104-0045
        • Recrutamento
        • GSK Investigational Site
        • Investigador principal:
          • Noboru Yamamoto
        • Contato:
        • Contato:
      • Tokyo, Japão, 135-8550
        • Recrutamento
        • GSK Investigational Site
        • Investigador principal:
          • Shigehisa Kitano
        • Contato:
        • Contato:
  • México
      • Mexico City, México, 14080
        • Recrutamento
        • GSK Investigational Site
        • Contato:
        • Contato:
        • Investigador principal:
          • Fidel David Huitzil-Melendez
    • Nuevo León
      • San Pedro Garza García, Nuevo León, México, 66260
        • Recrutamento
        • GSK Investigational Site
        • Contato:
        • Contato:
        • Investigador principal:
          • Raul Alejandro Andrade Moreno
  • Noruega
      • Oslo, Noruega, 0379
        • Recrutamento
        • GSK Investigational Site
        • Contato:
        • Contato:
        • Investigador principal:
          • Kristina Lindemann
  • Panamá
      • Panama City, Panamá
        • Recrutamento
        • GSK Investigational Site
        • Contato:
        • Contato:
        • Investigador principal:
          • Juan Pablo Bares
        • Investigador principal:
          • Omar Castillo-Fernandez
      • Punta Pacifica Panama City Panama, Panamá
        • Recrutamento
        • GSK Investigational Site
        • Contato:
        • Contato:
        • Investigador principal:
          • Ignacio Veliz
  • Polônia
      • Bialystok, Polônia, 15-027
        • Recrutamento
        • GSK Investigational Site
        • Contato:
        • Contato:
        • Investigador principal:
          • Beata Maćkowiak-Matejczyk
      • Gliwice, Polônia, 44-102
        • Recrutamento
        • GSK Investigational Site
        • Contato:
        • Contato:
        • Investigador principal:
          • Rafał Tarnawski
      • Józefów, Polônia, 05-410
        • Recrutamento
        • GSK Investigational Site
        • Contato:
        • Contato:
        • Investigador principal:
          • Rafal Stec
      • Warsaw, Polônia, 01-748
        • Concluído
        • GSK Investigational Site
  • Reino Unido
      • Glasgow, Reino Unido, G12 0YN
        • Retirado
        • GSK Investigational Site
      • London, Reino Unido, NW1 2BU
        • Concluído
        • GSK Investigational Site
  • Suécia
      • Stockholm, Suécia, 17164
        • Recrutamento
        • GSK Investigational Site
        • Contato:
        • Contato:
        • Investigador principal:
          • Lisa Liu Burstrom
  • Turquia (Türkiye)
      • Ankara, Turquia (Türkiye), 06590
        • Recrutamento
        • GSK Investigational Site
        • Contato:
        • Contato:
        • Investigador principal:
          • yuksel urun
      • Ankara, Turquia (Türkiye), 6170
        • Recrutamento
        • GSK Investigational Site
        • Contato:
        • Contato:
        • Investigador principal:
          • öztürk ateş
      • Istanbul, Turquia (Türkiye), 34010
        • Recrutamento
        • GSK Investigational Site
        • Contato:
        • Contato:
        • Investigador principal:
          • Fatih Selcukbiricik

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Participants must be 18 years of age inclusive or older, at the time of signing the informed consent, or the legal age of consent in the jurisdiction in which the study is taking place.

  • Participant capable of giving signed informed consent including compliance with the requirements and restrictions listed in the Informed consent form (ICF) and in this protocol.

  • Participants with pathologically confirmed advanced solid tumor specific for study Module (key local diagnostic molecular and/or immunophenotyping testing results/tumor cell phenotype results for confirmed diagnosis should be provided) with no more than 4 lines of prior systemic therapies. Please note:

    1. Adjuvant +/- neoadjuvant considered one line of therapy
    2. Maintenance therapy will be considered as part of the preceding line of therapy (i.e., not counted independently)
    3. Unplanned addition or switching to a new drug in a different class is considered a separate line of therapy. If an agent in a regimen is switched to another agent in the same class due to toxicity or intolerance (e.g. hypersensitivity reaction) this is considered part of the same line (i.e. not counted independently).

  • Requirements for tumor tissue samples: Archival or fresh tumor tissue is required for retrospective central assessment of B7H4 expression by immunohistochemistry (IHC) and other biomarker analysis. The archival tumor tissue should be from the most recent procedure (ideally obtained after the last anti-cancer treatment). If an archival tissue is not available a new biopsy should be performed, and the newly obtained tissue provided.

  • Participants have at least one target lesion as assessed per RECIST 1.1. A target lesion is defined as a measurable lesion that has not undergone locoregional treatment such as irradiation or that has unequivocal progression following locoregional treatment, with the longest diameter of ≥ 10 millimeter (mm) at Baseline (for lymph node lesions, the short axis should be ≥ 15 mm).

  • Participants have a life expectancy of at least 12 weeks per investigator assessment based on disease burden and extent of supportive care needed.

Inclusion criteria of participants under arm Module 1 (Mo-Rez +Dostarlimab) Endometrial Cancer Part 1A:

a. Participants with histologically documented, advanced (metastatic and/or unresectable) or recurrent endometrial cancer who have failed in adequate standard treatments, do not have effective standard treatment or are intolerant to standard of care, and who are not candidates for further curative external radiotherapy or brachytherapy.

Inclusion criteria of participants under arm Module 1 (Mo-Rez +Dostarlimab) Endometrial Cancer Part 1B:

  1. Diagnosis of endometrial cancer with confirmed mismatch repair proficient (MMRp) or microsatellites stable (MSS) tumor status by local test.
  2. Participants who have progressed on or are intolerant to at least 1 line of standard prior systemic therapy (including neoadjuvant or adjuvant as prior line), and who are not candidates for curative external radiotherapy or brachytherapy. Maintenance therapy will be considered part of the preceding line of therapy (i.e, not counted independently).

Inclusion criteria of participants under arm Module 2 (Mo-Rez +/- Bevacizumab) Ovarian Cancer Part 2A:

a. Participants with histologically or cytologically confirmed advanced epithelial ovarian cancer/fallopian tube/peritoneal cancer (any epithelial histology - mucinous, clear cell, carcinosarcoma, high/low grade serous, endometrioid) who have failed in adequate standard treatments, do not have effective standard treatment or are intolerant to standard of care.

Inclusion criteria of participants under arm Module 2 (GSK5733584 +/- Bevacizumab) Ovarian Cancer Part 2B:

  1. Participants whose advanced ovarian cancer/fallopian tube/peritoneal cancer has relapsed more than 6 months from the last dose of platinum before enrollment, i.e., platinum sensitive.

  2. Participants who have progressed on or are intolerant to at least 1 line of standard prior lines of chemotherapy and are not candidates for second cytoreductive surgery.

    • Participants willing to use adequate contraception.

Female participants:

A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies:

  • Is a Woman of non-childbearing potential (WONCBP) OR

  • Is a Woman of childbearing potential (WOCBP) and using a contraceptive method that is highly effective.

  • A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) within 24 hours before the first dose of study intervention

    • Has an ECOG performance status of 0 to 1.
    • Participants with normal organ and bone marrow function.

Exclusion Criteria:

  • Has a second 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 metastatic disease.

  • Has had any major surgery within 28 days prior to enrolment.

  • Has any history of prior allogenic or autologous bone marrow transplant or other solid organ transplant.

  • Has known sensitivity to study intervention components, Mo-Rez (antibody-drug conjugate, antibody, free cytotoxin GSK5757810A) and combination partner, or its excipients or other allergy that, in the opinion of the investigator, contraindicates participation in the study.

  • Has any following cardiological examination abnormality:

    1. history in prior year of clinically significant or uncontrolled cardiac disease, acute myocardial infarction, NYHA Class III or IV congestive heart failure or clinically significant arrhythmia not controlled by standard of care therapy.
    2. Corrected QT Interval (QTcF) >450 millisecond (msec) or QTcF >480 msec for participants with bundle branch block

  • Has untreated brain or CNS metastases or brain/CNS metastases rapidly progressing requiring urgent medical intervention.

  • Any evidence of current interstitial lung disease (ILD) or pneumonitis or a prior history of ILD or non-infectious pneumonitis.

  • Has a history of autoimmune disease that has required systemic treatments in the 2 years prior to screening (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy is not considered a form of systemic therapy (e.g., thyroid hormone for autoimmune thyroiditis or insulin is not exclusionary).

  • Clinically significant bleeding symptoms, significant bleeding tendency, or bleeding tumors within 1 month prior to the first dose of study treatment.

  • Serious or poorly controlled hypertension, including history of hypertensive crisis, hypertensive encephalopathy; adjustment of antihypertensive medications due to poor blood pressure control within 2 weeks prior to the first dose of study treatment;

  • Has any active renal condition (e.g., infection, requirement for dialysis, or any other active significant renal condition or dehydrated condition that could affect the participant's safety). Note: renal obstruction successfully managed by stenting is permitted.

  • Has any serious and/or unstable medical condition (such as clinical symptoms of intestinal obstruction) or psychiatric disorder or other condition(s) (including laboratory assessment abnormalities) that could interfere with the participant's safety, obtainment of informed consent, or compliance to the study procedures.

  • Participants with known history of Human immunodeficiency virus (HIV).

Exclusion criteria of participants under arm Module 1 (Mo-Rez +Dostarlimab) Endometrial Cancer:

  1. Has mesenchymal tumor of the uterus (uterine sarcoma).
  2. Has experienced symptomatic pericarditis of any etiology within 6 months of study treatment or any of the following with prior immunotherapy: any imAE ≥ Grade 3, immune-mediated severe neurologic events of any-grade (e.g., myasthenic syndrome/myasthenia gravis, encephalitis Guillain-Barré Syndrome, or transverse myelitis), exfoliative dermatitis of any grade (SJS, TEN, or DRESS syndrome), or myocarditis of any grade.

Exclusion criteria of participants under arm Module 2 (Mo-Rez +/-Bevacizumab) Ovarian Cancer:

  1. Participants with wound healing complications or incompletely healed wounds.

  2. Participants with history or evidence of gastrointestinal perforation, tracheoesophageal fistula, or any grade 4 fistula; participants with gastrointestinal fistula, visceral fistula, or abdominal abscess within 6 months prior to the first dose, participants with history of osteonecrosis of the jaw.

  3. Participants who have evidence of recto-sigmoid involvement by pelvic examination or bowel involvement on CT scan or clinical symptoms of bowel obstruction.

  4. Participants with congenital bleeding diathesis, acquired coagulopathy, recent pulmonary haemorrhage/ haemoptysis (> 2.5 mL of red blood or ½ teaspoon) within the last 3 months. Participants receiving treatment for thromboembolism are permitted as long as they have been on a stable dose of anticoagulation for at least 1 month.

  5. Participant has history of congestive heart failure (CHF) or baseline LVEF <50% or institutional lower limits of normal.

  6. Participant with history of nephrotic syndrome or grade 3 proteinuria. Participants has proteinuria as demonstrated by urine dipstick for proteinuria ≥2 (participants discovered to have ≥2 proteinuria on dipstick at baseline should undergo 24-hour urine collection and must demonstrate ≤1 g of protein in 24 hours to be eligible).

    • Has an Alanine transaminase (ALT) value >2.5x Upper Limit of Normal (ULN) and for participants with documented liver metastases/tumor infiltration has an ALT value >5x ULN.
    • Has a total bilirubin value >1.5x ULN.
    • Has documented presence of HBsAg and/or HBcAb, or HBsAb (except for presence of HBsAb attributable to previous vaccination) at screening or within 3 months prior to the first dose of study intervention.
    • Has a positive HCV antibody test result at screening or within 3 months prior to the first dose of study intervention.
    • Has received prior therapy with topoisomerase-1 inhibitors or ADC with topoisomerase-1 inhibitor warhead, or B7H4 targeted therapy.
    • Has received treatment with any cytotoxic chemotherapy drugs or other anti-tumor drugs (including endocrine therapy, molecular targeted therapy, immunotherapy, biotherapy, and investigational drug) within 30 days or 5 half-lives, whichever is shorter of a medicinal product prior to the first dose of study drug; or need to continue these drugs during the study.
    • Use of inhibitors of P-gp, breast cancer resistance protein (BCRP) or OATP1B1/1B3 within 7 days prior to the first dose of study drug. P-gp inducers should be discontinued for at least 14 days before the start of the study.
    • Have received locoregional radiation therapy within 2 weeks prior to the first dose of study drug; more than 30% of bone marrow irradiation or wide-field radiation therapy within 4 weeks prior to the first dose of study treatment.
    • Has serious infections within 4 weeks prior to the first dose, including but not limited to infectious complications, bacteremia, severe pneumonia treated with intravenous antibiotics for ≥2 weeks.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Module 1 (Mo-Rez +Dostarlimab) Endometrial Cancer
Medicamento: Mo-Rez

Mo-Rez will be administered intravenously (IV).

Medicamento: Dostarlimab

Dostarlimab will be administered IV.
Experimental: Module 2 (Mo-Rez +/-Bevacizumab) Ovarian Cancer
Medicamento: Mo-Rez

Mo-Rez will be administered intravenously (IV).

Medicamento: Bevacizumab

Bevacizumab will be administered IV.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Parte A: Porcentagem de participantes com toxicidades limitantes da dose (DLTs)
Prazo: Aproximadamente 7 meses
Aproximadamente 7 meses
Parte A: Número de participantes com eventos adversos (EAs), eventos adversos imunes mediados (IMAES), eventos adversos de interesse especial (AESI), eventos adversos graves (SAEs) por gravidade
Prazo: Até aproximadamente 22 meses
Até aproximadamente 22 meses
Parte A: Número de participantes com eventos adversos (EAs), eventos adversos imunes mediados (IMAES), eventos adversos de interesse especial (AESI), eventos adversos graves (SAEs) por frequência
Prazo: Até aproximadamente 22 meses
Até aproximadamente 22 meses
Part B: Confirmed Objective Response Rate (ORR)
Prazo: Up to approximately 37 months

ORR is defined as the percentage of participants with a best overall confirmed (BOR) of Partial Response (PR) or better per Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Up to approximately 37 months

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Parte B: Número de participantes com eventos adversos (EAs), eventos adversos imunes mediados (IMAES), eventos adversos de interesse especial (AESI), eventos adversos graves (SAEs) por frequência
Prazo: Até aproximadamente 37 meses
Até aproximadamente 37 meses
Parte B: Número de participantes com eventos adversos (EAs), eventos adversos imunes mediados (IMAES), eventos adversos de interesse especial (AESI), eventos adversos graves (SAEs) por gravidade
Prazo: Até aproximadamente 37 meses
Até aproximadamente 37 meses
Peças A e B: Número de participantes com anticorpos antidrogas (ADA)
Prazo: Até aproximadamente 37 meses
Até aproximadamente 37 meses
Peças A e B: Número de participantes com anticorpo neutralizante (NAB)
Prazo: Até aproximadamente 37 meses
Até aproximadamente 37 meses
Peças A e B: Número de participantes com mudanças clinicamente significativas nos sinais vitais, parâmetros de laboratório e eletrocardiograma (ECG)
Prazo: Até aproximadamente 37 meses
Até aproximadamente 37 meses
Part B: Proportion of participants with CA-125 response
Prazo: Up to approximately 37 months
Up to approximately 37 months
Parts A and B: Maximum observed concentration (Cmax) of Mo-Rez
Prazo: Up to approximately 37 months
Up to approximately 37 months
Parts A and B: Time to reach Cmax (tmax) of Mo-Rez
Prazo: Up to approximately 37 months
Up to approximately 37 months
Parts A and B: Trough concentration (Ctrough) of Mo-Rez
Prazo: Up to approximately 37 months
Up to approximately 37 months
Parts A and B: Area under the concentration-time curve (AUC) of Mo-Rez
Prazo: Up to approximately 37 months
Up to approximately 37 months
Parts A and B: Titers of ADA to Mo-Rez
Prazo: Up to approximately 37 months
Up to approximately 37 months
Part A: Confirmed Objective Response Rate (ORR)
Prazo: Up to approximately 22 months

ORR is defined as the percentage of participants with a best overall confirmed (BOR) of Partial Response (PR) or better per Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Up to approximately 22 months
Parts A and B: Duration of response (DoR)
Prazo: Up to approximately 37 months

DoR is defined as the time from date of first documented evidence of PR or better to the date of disease progression or death due to any cause.
Up to approximately 37 months
Parts A and B: Progression-free survival (PFS)
Prazo: Up to approximately 37 months

PFS is defined as time from the date of randomization (Part B) / first dose of study intervention (Part A or B if single arm) to the date of disease progression according to investigator assessment or death due to any cause, whichever occurs first.
Up to approximately 37 months
Part B: Overall Survival (OS)
Prazo: Up to approximately 37 months

OS is defined as the time from randomization (or date of first dose if single arm) to the date of death due to any cause.
Up to approximately 37 months
Parts A and B: Change from Baseline in Eastern Cooperative Oncology Group Performance Scale (ECOG PS) score
Prazo: Baseline and up to approximately 37 months

ECOG PS is used for measuring how the disease impacts a participant's daily living abilities. The grades for the scale range from 0 (fully active) to 5 (dead), with increasing severity.
Baseline and up to approximately 37 months

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

GlaxoSmithKline

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

4 de março de 2025

Conclusão Primária (Estimado)

21 de junho de 2027

Conclusão do estudo (Estimado)

10 de outubro de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

22 de janeiro de 2025

Enviado pela primeira vez que atendeu aos critérios de CQ

22 de janeiro de 2025

Primeira postagem (Real)

28 de janeiro de 2025

Atualizações de registro de estudo

Última Atualização Postada (Real)

2 de novembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

30 de outubro de 2026

Última verificação

1 de outubro de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 223559
  • 2024-517147-31-00 (Ctis: CTIS (EU))

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.pdf

Prazo de Compartilhamento de IPD

Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.

Critérios de acesso de compartilhamento IPD

Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.

Tipo de informação de suporte de compartilhamento de IPD

  • PROTOCOLO DE ESTUDO
  • SEIVA
  • CIF
  • CSR

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Sim

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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