Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruitment ended
Participants planned
160
Countries
3
Sites
7
Locally advanced or metastatic solid tumors
Key facts
- Sponsor
- Chugai Pharmaceutical Co. Ltd.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 31 Jul 2024 → ongoing
- Decision date (initial)
- 2024-03-04
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-508764-30-00
- EudraCT number
- 2019-003329-11
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Locally advanced or metastatic solid tumors
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10028997 | Neoplasm malignant | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Chugai Pharmaceutical Co. Ltd.
- Sponsor organisation
- Chugai Pharmaceutical Co. Ltd.
- Address
- 1-1 Nihonbashi-Muromachi 2-Chome, Chuo-ku Chuo-ku
- City
- Chuo
- Postcode
- 103-8324
- Country
- Japan
Scientific contact point
- Organisation
- Chugai Pharmaceutical Co. Ltd.
- Contact name
- Clinical trials information
Public contact point
- Organisation
- Chugai Pharmaceutical Co. Ltd.
- Contact name
- Clinical trials information
Locations
3 EU/EEA countries · 7 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Poland | Ended | 10 | 2 |
| Romania | Ongoing, recruitment ended | 10 | 2 |
| Spain | Ended | 10 | 3 |
| Rest of world
Japan, Taiwan, United Kingdom
|
— | 130 | — |
Investigational sites
Med Polonia Sp. z o.o.
N/A, Obornicka 262, 60-693, Poznan
Medicover Integrated Clinical Services Sp. z o.o.
MICS Centrum Medyczne Toruń, Ul. Stefana Batorego 18/22, 87-100, Torun
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti
Phase I Unit, Medical Oncology II, Radiotherapy I, Soseaua Fundeni 252, 022328, Bucharest
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Medical Oncology, Strada Republicii 34-36, 400015, Cluj-Napoca
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 |
|---|---|---|---|---|---|
| Poland | 2023-03-06 | 2024-01-23 | 2025-07-18 | ||
| Romania | 2025-01-29 | 2025-01-31 | 2025-07-25 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 1 · Art. 38 CTR
Temporary halt TH-16776
- Halt date
- 2024-02-27
- Member states concerned
- Poland
- Publication date
- 2024-03-12
- Reason
- Sponsor decision
- Explanation
- After careful review of the clinical data obtained so far, the Sponsor, Chugai Pharmaceuticals Co., has decided to amend the protocol and submit a substantial amendment. Until the protocol amendment is authorized by relevant health authorities, ECs and IRBs, Chugai will temporarily pause the enrolment in phase Ib expansion cohort stage part1.
- Follow-up measures
- All investigators in active countries/sites have been informed by email of the temporary pause of enrolment in phase Ib expansion cohort stage part1.
Ongoing patients in the STA101JG study will continue with the planned dosing. There is currently no ongoing patients in Poland.
The sponsor plans to update the protocol as soon as possible for submission - Benefit-risk balance changed
- No
- Treatment stopped
- No
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-11-10 | Spain | Acceptable 2023-12-18
|
2023-12-18 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-05-17 | Spain | Acceptable 2024-06-26
|
2024-07-02 |
| 3 | SUBSEQUENT ADDITION OF MSC | APP-3 | 2024-09-20 | Acceptable 2024-06-26
|
2024-12-16 | |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-09-20 | Spain | Acceptable 2024-06-26
|
2024-09-20 |
| 5 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-02-21 | Spain | Acceptable 2025-04-23
|
2025-04-27 |
| 6 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-09-10 | Acceptable 2025-10-24
|
2025-12-02 | |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-03-31 | Acceptable 2025-10-24
|
2026-03-31 |