Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
233
Countries
5
Sites
19
Relapsed/refractory malignancy with documented diagnosis of human epidermal growth factor receptor 2 (HER2) alterations
Key facts
- Sponsor
- Iambic Therapeutics Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 7 Oct 2025 → ongoing
- Decision date (initial)
- 2025-09-11
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-519188-17-00
- ClinicalTrials.gov
- NCT06253871
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Relapsed/refractory malignancy with documented diagnosis of human epidermal growth factor receptor 2 (HER2) alterations
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 28.0 | PT | 10075653 | HER2 gene amplification | 100000004850 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Iambic Therapeutics Inc.
- Sponsor organisation
- Iambic Therapeutics Inc.
- Address
- 5627 Oberlin Drive Suite 120
- City
- San Diego
- Postcode
- 92121-3748
- Country
- United States
Scientific contact point
- Organisation
- Iambic Therapeutics Inc.
- Contact name
- Kelly Griffis
Public contact point
- Organisation
- Iambic Therapeutics Inc.
- Contact name
- Kelly Griffis
Locations
5 EU/EEA countries · 19 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 33 | 5 |
| Ireland | Ongoing, recruiting | 15 | 3 |
| Italy | Authorised, recruiting | 15 | 4 |
| Netherlands | Ongoing, recruiting | 15 | 1 |
| Spain | Ongoing, recruiting | 19 | 6 |
| Rest of world
Korea, Republic of, United Kingdom, United States
|
— | 136 | — |
Investigational sites
Institut De Cancerologie De L Ouest
Oncologie Medicale, Boulevard Jacques Monod, 44805, Saint-Herblain Cedex
Institut Paoli Calmettes
Oncologie, 232 Boulevard De Sainte Marguerite, Bp 156, Marseille
Centr Georges Francois Leclerc
Oncologie Medicale, 1 Rue Professeur Marion, 21000, Dijon
Oncopole Claudius Regaud
Oncologie Medicale, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
Institut Gustave Roussy
Departement d’Innovation Therapeutique et des Essais Precoces (DITEP, 114 Rue Edouard Vaillant, 94800, Villejuif
Mater Misericordiae University Hospital
Oncology, Eccles Street, D07 R2WY, Dublin 7
St Vincent's University Hospital
Medical Oncology, Elm Park Merrion Road, D04 T6F4, Dublin 4
Cork University Hospital
Cancer Research, Wilton, T12 DC4A, Cork
ASST Grande Ospedale Metropolitano Niguarda
Oncology, Piazza Dell'ospedale Maggiore 3, 20162, Milan
Azienda Ospedaliero Universitaria Careggi
Oncology, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
Istituto Europeo Di Oncologia S.r.l.
Oncology, Via Giuseppe Ripamonti 435, 20141, Milan
Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
Oncology, Via Sergio Pansini 5, 80131, Naples
NKI
Clinical Research Unit (CRU), Plesmanlaan 121, 1066 CX, Amesterdam
Hospital Universitario Hm Sanchinarro
Clinical Investigator Early Phase Trials Unit, Calle Ona 10, 28050, Madrid
Hospital Universitario Regional De Malaga
Medical Oncology, Avenida De Carlos De Haya S/N, 29010, Malaga
Hospital Universitari Vall D Hebron
Medical Oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario 12 De Octubre
Medical Oncology, Avenida De Cordoba Sn, 28041, Madrid
Hospital Clinico Universitario De Valencia
Medical Oncology, Avenida Blasco Ibanez 17, 46010, Valencia
University Hospital Virgen Del Rocio S.L.
Medical Oncology, Avenida De Manuel Siurot S/n, 41013, Sevilla
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2025-11-27 | 2026-01-06 | |||
| Ireland | 2025-10-07 | 2026-01-05 | |||
| Italy | 2026-01-16 | ||||
| Netherlands | 2025-11-18 | 2025-11-21 | |||
| Spain | 2025-10-13 | 2025-11-25 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-06-11 | Spain | Acceptable 2025-09-10
|
2025-09-11 |