Clinical trial • Phase I/II • Oncology
VVD-159642 (RAS-PI3Kα inhibitor) for Advanced solid tumors
Phase I/II trial of VVD-159642 (RAS-PI3Kα inhibitor) for Advanced solid tumors. open-label, none/not specified-controlled, adaptive. 120 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Advanced solid tumors
- Trial Stage
- Phase I/II
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 30-06-2025
- First CTIS Authorization Date
- 26-09-2025
Trial design
open-label, none/not specified-controlled, adaptive Phase I/II trial across 4 sites in Spain.
- Open Label
- Yes
- Comparator
- None/Not specified
- Adaptive
- True - first-in-human dose escalation and dose expansion design as stated in the public title
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 120
Eligibility
Recruits 120 No vulnerable populations selected.
- Vulnerable Population
- No vulnerable populations selected
Recruitment
- Planned Sample Size
- 120
- Recruitment Window Months
- 18
Geography
- Total Number Of Sites
- 4
- Total Number Of Participants
- 120
Spain
- Earliest CTIS Part Ii Submission Date
- 08-08-2025
- Latest Decision Or Authorization Date
- 26-09-2025
- Processing Time Days
- 49
- Number Of Sites
- 4
- Number Of Participants
- 32
Sites
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Oncology
- Contact Person Name
- Victor Moreno
- Contact Person Email
- Victor.moreno@startmadrid.com
- Site Name
- Hospital Universitario Hm Sanchinarro
- Department Name
- Oncology
- Contact Person Name
- Emiliano Calvo
- Contact Person Email
- emiliano.calvo@startmadrid.com
- Site Name
- Hospital Hm Nou Delfos
- Department Name
- Oncology
- Contact Person Name
- Tatiana Hernandez
- Contact Person Email
- Tatiana.hernandez@start-barcelona.com
- Site Name
- Hospital Universitario Quironsalud Madrid
- Department Name
- Oncology
- Contact Person Name
- Valentina Boni
- Contact Person Email
- vboni@nextoncology.eu
Sponsor
Primary sponsor
- Full Name
- Vividion Therapeutics Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Investigational products
- Investigational Product Name
- VVD-159642
- Active Substance
- VVD-159642 (RAS-PI3Kα inhibitor)
- Modality
- Small molecule
- First In Human
- Yes
- Combination Treatment
- Yes
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