Clinical trial • Phase I • Oncology
OMTX705 for Advanced solid tumors | Carcinoma | Leiomyosarcoma | Sarcoma
Phase I trial of OMTX705 for Advanced solid tumors | Carcinoma | Leiomyosarcoma | Sarcoma. adaptive. 113 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Advanced solid tumors | Carcinoma | Leiomyosarcoma | Sarcoma
- Trial Stage
- Phase I
- Drug Modality
- ADC | Monoclonal antibody | Small molecule
Key dates
- Initial CTIS Submission Date
- 19-06-2024
- First CTIS Authorization Date
- 01-07-2024
Trial design
adaptive Phase I trial across 11 sites in Spain.
- Adaptive
- Yes
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 113
Recruitment
- Planned Sample Size
- 113
- Recruitment Window Months
- 68
Geography
- Total Number Of Sites
- 11
- Total Number Of Participants
- 113
Spain
- Earliest CTIS Part Ii Submission Date
- 28-06-2024
- Latest Decision Or Authorization Date
- 22-04-2026
- Processing Time Days
- 663
- Number Of Sites
- 11
- Number Of Participants
- 113
Sites
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Oncology
- Principal Investigator Name
- Luis Paz-Ares Rodríguez
- Principal Investigator Email
- lpazares@hotmail.com
- Contact Person Name
- Luis Paz-Ares Rodríguez
- Contact Person Email
- lpazares@hotmail.com
- Site Name
- Hospital General Universitario Gregorio Maranon
- Department Name
- Oncology
- Principal Investigator Name
- Rosa Álvarez Álvarez
- Principal Investigator Email
- rosa.alvarez@gmail.com
- Contact Person Name
- Rosa Álvarez Álvarez
- Contact Person Email
- rosa.alvarez@gmail.com
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Oncology
- Principal Investigator Name
- Justo Ortega Anselmi
- Principal Investigator Email
- justo.ortega@salud.madrid.org
- Contact Person Name
- Justo Ortega Anselmi
- Contact Person Email
- justo.ortega@salud.madrid.org
- Site Name
- MD Anderson Cancer Center
- Department Name
- Oncology
- Principal Investigator Name
- Ricardo Cubedo Cervera
- Principal Investigator Email
- rcubedo@mdanderson.es
- Contact Person Name
- Ricardo Cubedo Cervera
- Contact Person Email
- rcubedo@mdanderson.es
- Site Name
- Fundacion Onkologikoa Fundazioa
- Department Name
- Oncology
- Principal Investigator Name
- Ander Urruticoechea
- Principal Investigator Email
- anderu@onkologikoa.org
- Contact Person Name
- Ander Urruticoechea
- Contact Person Email
- anderu@onkologikoa.org
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Department Name
- Oncology
- Principal Investigator Name
- Irene Carrasco García
- Principal Investigator Email
- irenecg1990@gmail.com
- Contact Person Name
- Irene Carrasco García
- Contact Person Email
- irenecg1990@gmail.com
- Site Name
- Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca
- Department Name
- Oncology
- Principal Investigator Name
- Claudia Valverde Morales
- Principal Investigator Email
- cvalverde@vhio.net
- Contact Person Name
- Claudia Valverde Morales
- Contact Person Email
- cvalverde@vhio.net
- Site Name
- Clinica Universidad De Navarra
- Department Name
- Oncology
- Principal Investigator Name
- Mariano Ponz Sarvisé
- Principal Investigator Email
- mponz@unav.es
- Contact Person Name
- Mariano Ponz Sarvisé
- Contact Person Email
- mponz@unav.es
- Site Name
- Institut Catala D'oncologia
- Department Name
- Medical Oncology
- Principal Investigator Name
- Marta Gil Martín
- Principal Investigator Email
- mgilmartin@iconcologia.net
- Contact Person Name
- Marta Gil Martín
- Contact Person Email
- mgilmartin@iconcologia.net
- Site Name
- Hospital Universitario Donostia
- Department Name
- Medical Oncology
- Principal Investigator Name
- Ana Paisán Ruiz
- Principal Investigator Email
- ana.paisanruiz@osakidetza.eus
- Contact Person Name
- Ana Paisán Ruiz
- Contact Person Email
- ana.paisanruiz@osakidetza.eus
- Site Name
- Complexo Hospitalario Universitario De Santiago
- Department Name
- Oncology
- Principal Investigator Name
- Rafael López López
- Principal Investigator Email
- rafael.lopez.lopez@sergas.es
- Contact Person Name
- Rafael López López
- Contact Person Email
- rafael.lopez.lopez@sergas.es
Sponsor
Primary sponsor
- Full Name
- Oncomatryx Biopharma S.L.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Spain
Investigational products
- Investigational Product Name
- OMTX705
- Active Substance
- OMTX705
- Modality
- ADC
- Investigational Product Name
- Pembrolizumab
- Active Substance
- Pembrolizumab
- Modality
- Monoclonal antibody
- Investigational Product Name
- Pazopanib
- Active Substance
- Pazopanib
- Modality
- Small molecule
- Combination Treatment
- Yes
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