288
Participants
Start Date
May 21, 2023
Primary Completion Date
April 30, 2027
Study Completion Date
April 30, 2028
Module 1 (GRWD5769 on its own as monotherapy)
"Module 1 will initially be conducted in 4 study parts:~Part A: Monotherapy dose escalation (where the safety of increasing doses of GRWD5769 will initially be assessed in a small group of patients, overseen by a safety review committee)~Part B: (Optional) Monotherapy dose expansion part (to look at the effect of GRWD5769 on the body, and of the body on GRWD5769, at particular dose levels to include evaluation of biopsies of tumour tissue)~Part C: (Optional) Intra-patient dose escalation (where a patient may receive three different GRWD5769 doses so that blood levels at each dose can be measured in an individual)~Part D: Monotherapy dose expansion group(s) (where a dose of GRWD5769 may be chosen to be evaluated in specific types of cancer)"
Module 2 (GRWD5769 in combination with cemiplimab, administered IV)
"Module 2 will initially be conducted as 3 study parts, similar to those above, but looking at GRWD5769 when given in combination with cemiplimab:~Part A: Combination therapy dose escalation (like Module 1 Part A)~Part B: (Optional) Combination therapy dose expansion part (like Module 1 Part B)~Part C: Combination therapy dose expansion group(s) (where a dose of GRWD5769 given with cemiplimab will be evaluated in specific types of cancer)"
RECRUITING
GenesisCare Research, Adelaide
RECRUITING
Southern Oncology Clinical Research Unit (SOCRU), Bedford Park
RECRUITING
Blacktown Hospital, Blacktown
RECRUITING
Kinghorn Cancer Centre (KCC), Darlinghurst
RECRUITING
Austin Health, Heidelberg
RECRUITING
Alfred Health, Melbourne
RECRUITING
Mater Research, South Brisbane
RECRUITING
Cancer Care Wollongong, Wollongong
RECRUITING
Centre Léon Bérard, Lyon
RECRUITING
Institut Paoli-Calmettes, Marseille
RECRUITING
Centre Eugène Marquis, Rennes
RECRUITING
Institut de Cancérologie de l'Ouest (ICO), Saint-Herblain
NOT_YET_RECRUITING
ICANS - Institut de Cancérologie Strasbourg, Strasbourg
RECRUITING
IUCT Oncopole - Institut Claudius Regaud, Toulouse
RECRUITING
Institut Gustave Roussy, Villejuif
RECRUITING
Hospital Universitario Vall d'Hebrón (VHIO), Barcelona
RECRUITING
START Barcelona - Hospital HM Nou Delfos, Barcelona
RECRUITING
Clinica Universitaria de Navarra Madrid, Madrid
RECRUITING
START Madrid - Centro Integral Oncológico Clara Campal (HM CIOCC), Madrid
RECRUITING
START Madrid - Hospital Universitario Fundacion Jimenez Diaz, Madrid
RECRUITING
Hospital Universitario Virgen de la Victoria, Málaga
RECRUITING
Clinica Universitaria de Navarra Pamplona, Pamplona
RECRUITING
INCLIVA-Hospital Clínico Universitario de Valencia, Valencia
RECRUITING
Western General Hospital, Edinburgh
RECRUITING
Clatterbridge Cancer Centre, Liverpool
RECRUITING
Hammersmith Hospitals NHS Trust, London
RECRUITING
Royal Free Hospital, London
RECRUITING
Christie NHS Foundation Trust, Manchester
RECRUITING
Newcastle Upon Tyne Hospital, Newcastle
Lead Sponsor
Grey Wolf Therapeutics
OTHER