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Uno studio di GSK5733584 in combinazione con terapie anticancro per tumori solidi avanzati

30 ottobre 2026 aggiornato da: GlaxoSmithKline

Uno studio multi-coro randomizzato di fase I/II per valutare la sicurezza, la tollerabilità, la farmacocinetica e l'attività clinica di GSK5733584 in combinazione con agenti anti-cancro nei partecipanti con tumori solidi avanzati

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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

305

Fase

  • Fase 2
  • Fase 1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Module 1 (Mo-Rez +Dostarlimab) Endometrial Cancer
Droga: Mo-Rez

Mo-Rez will be administered intravenously (IV).

Droga: Dostarlimab

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

Mo-Rez will be administered intravenously (IV).

Droga: Bevacizumab

Bevacizumab will be administered IV.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Parte A: Percentuale di partecipanti con tossicità per limitazione della dose (DLT)
Lasso di tempo: Circa 7 mesi
Circa 7 mesi
Parte A: Numero di partecipanti con eventi avversi (eventi avversi), eventi avversi immuno-mediati (IMAES), eventi avversi di interesse speciale (AESI), eventi avversi gravi (SAE) per gravità
Lasso di tempo: Fino a circa 22 mesi
Fino a circa 22 mesi
Parte A: Numero di partecipanti con eventi avversi (eventi avversi), eventi avversi immuno-mediati (IMAES), eventi avversi di interesse speciale (AESI), eventi avversi gravi (SAE) per frequenza
Lasso di tempo: Fino a circa 22 mesi
Fino a circa 22 mesi
Part B: Confirmed Objective Response Rate (ORR)
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Parte B: numero di partecipanti con eventi avversi (eventi avversi), eventi avversi immuno-mediati (IMAES), eventi avversi di interesse speciale (AESI), eventi avversi gravi (SAE) per frequenza
Lasso di tempo: Fino a circa 37 mesi
Fino a circa 37 mesi
Parte B: numero di partecipanti con eventi avversi (eventi avversi), eventi avversi immuno-mediati (IMAES), eventi avversi di interesse speciale (AESI), eventi avversi gravi (SAE) per gravità
Lasso di tempo: Fino a circa 37 mesi
Fino a circa 37 mesi
Parti A e B: numero di partecipanti con anticorpi anti-farmaco (ADA)
Lasso di tempo: Fino a circa 37 mesi
Fino a circa 37 mesi
Parti A e B: numero di partecipanti con anticorpo neutralizzante (NAB)
Lasso di tempo: Fino a circa 37 mesi
Fino a circa 37 mesi
Parti A e B: numero di partecipanti con cambiamenti clinicamente significativi nei segni vitali, nei parametri di laboratorio ed elettrocardiogramma (ECG)
Lasso di tempo: Fino a circa 37 mesi
Fino a circa 37 mesi
Part B: Proportion of participants with CA-125 response
Lasso di tempo: Up to approximately 37 months
Up to approximately 37 months
Parts A and B: Maximum observed concentration (Cmax) of Mo-Rez
Lasso di tempo: Up to approximately 37 months
Up to approximately 37 months
Parts A and B: Time to reach Cmax (tmax) of Mo-Rez
Lasso di tempo: Up to approximately 37 months
Up to approximately 37 months
Parts A and B: Trough concentration (Ctrough) of Mo-Rez
Lasso di tempo: Up to approximately 37 months
Up to approximately 37 months
Parts A and B: Area under the concentration-time curve (AUC) of Mo-Rez
Lasso di tempo: Up to approximately 37 months
Up to approximately 37 months
Parts A and B: Titers of ADA to Mo-Rez
Lasso di tempo: Up to approximately 37 months
Up to approximately 37 months
Part A: Confirmed Objective Response Rate (ORR)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

GlaxoSmithKline

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

4 marzo 2025

Completamento primario (Stimato)

21 giugno 2027

Completamento dello studio (Stimato)

10 ottobre 2028

Date di iscrizione allo studio

Primo inviato

22 gennaio 2025

Primo inviato che soddisfa i criteri di controllo qualità

22 gennaio 2025

Primo Inserito (Effettivo)

28 gennaio 2025

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

2 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

30 ottobre 2026

Ultimo verificato

1 ottobre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

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

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano 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

Periodo di condivisione 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.

Criteri di accesso alla condivisione 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 di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA
  • ICF
  • RSI

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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