Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
198
Countries
4
Sites
6
Advanced Solid Tumors
Key facts
- Sponsor
- Ikena Oncology Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- completed 27 Aug 2024
- Decision date (initial)
- 2024-05-14
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2022-502622-40-00
- ClinicalTrials.gov
- NCT05228015
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced Solid Tumors
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10027475 | Metastatic breast cancer | 10029104 |
| 21.0 | PT | 10041823 | Squamous cell carcinoma | 100000004864 |
| 21.1 | LLT | 10065252 | Solid tumor | 10029104 |
| 20.0 | PT | 10033128 | Ovarian cancer | 100000004864 |
| 21.0 | PT | 10014733 | Endometrial cancer | 100000004864 |
| 21.1 | LLT | 10008229 | Cervical cancer | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Ikena Oncology Inc.
- Sponsor organisation
- Ikena Oncology Inc.
- Address
- 645 Summer Street Suite 101
- City
- Boston
- Postcode
- 02210-2135
- Country
- United States
Scientific contact point
- Organisation
- Ikena Oncology Inc.
- Contact name
- Katherine Kim, MD
Public contact point
- Organisation
- Ikena Oncology Inc.
- Contact name
- Katherine Kim, MD
Locations
4 EU/EEA countries · 6 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 23 | 3 |
| Italy | Ended | 2 | 1 |
| Netherlands | Ended | 2 | 1 |
| Spain | Ended | 4 | 1 |
| Rest of world
United Kingdom, United States
|
— | 167 | — |
Investigational sites
Institut Bergonie
Service d’Oncologie Médicale, 229 Cours De L Argonne, 33000, Bordeaux
Centre Oscar Lambret
Service d’Oncologie Générale, 3 Rue Frederic Combemale, 59000, Lille
Centre Leon Berard
Service d’Oncologie Médicale, 28 Rue Laennec, 69008, Lyon
Fondazione IRCCS Istituto Nazionale Dei Tumori
Programma Studi di Fase I c/o S.C. Oncologia Medica 2 Tumori mesenchimali dell’adulto e tumori vari, Via Giacomo Venezian 1, 20133, Milan
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Lungcancer and thoraxoncology, Plesmanlaan 121, 1066 CX, Amsterdam
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-01-19 | France | Acceptable 2024-05-14
|
2024-05-14 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-05-23 | Acceptable 2024-05-14
|
2024-05-23 |