Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
59
Countries
1
Sites
2
Advanced solid tumors and colorectal cancer
Key facts
- Sponsor
- Merck Healthcare KGaA
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 8 Jan 2025 → 3 Dec 2025
- Decision date (initial)
- 2024-10-21
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-514155-15-00
- ClinicalTrials.gov
- NCT06509906
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced solid tumors and colorectal cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10065252 | Solid tumor | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Merck Healthcare KGaA
- Sponsor organisation
- Merck Healthcare KGaA
- Address
- Frankfurter Strasse 250
- City
- Darmstadt
- Postcode
- 64293
- Country
- Germany
Scientific contact point
- Organisation
- Merck Healthcare KGaA
- Contact name
- Global Regulatory Affairs
Public contact point
- Organisation
- Merck Healthcare KGaA
- Contact name
- Global Regulatory Affairs
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ended | 14 | 2 |
| Rest of world
Korea, Republic of, United States, Japan, Australia
|
— | 45 | — |
Investigational sites
Hospital Quironsalud Barcelona
Oncology - Phase I Unit, Placa D'alfonso Comin 5-7, 08023, Barcelona
Hospital Universitario Quironsalud Madrid
Unidad de Ensayos Clínicos Fases I, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
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 |
|---|---|---|---|---|---|
| Spain | 2025-01-08 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 1 · Art. 38 CTR
Temporary halt TH-71270
- Halt date
- 2025-02-06
- Member states concerned
- Spain
- Publication date
- 2025-02-18
- Reason
- Sponsor decision
- Explanation
- Sponsor’s decision is based on the recommendations of the Safety Monitoring Committee (SMC) and aligned with the safety measures specified in the study protocol. The SMC’s conclusion is based on an evaluation of the initial two sentinel dosing participants who received M9466 in combination with irinotecan, both of whom experienced poor tolerance to the study treatment and a febrile neutropenia Grade 3 as a dose-limiting toxicities (DLT).
In light of these findings, the Sponsor has decided to pause the study to reassess the dosage of the M9466 and irinotecan combination and amend the study protocol accordingly.
SMC Recommendation Form and Meeting minutes are appended to this notification. - Follow-up measures
- Sponsor will reassess the dosage of the M9466 and irinotecan combination and amend the study protocol accordingly, which would include a review of the grid for dose/schedule with the support of pre-clinical work and pharmacokinetic (PK)/pharmacodynamic (PD) modelling.
The study will only be re-initiated upon Agency approval of the amended study protocol which will be submitted as substantial modification once available. - Benefit-risk balance changed
- Yes
- Treatment stopped
- Yes
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-05 | Spain | Acceptable 2024-10-21
|
2024-10-21 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-08-20 | Spain | Acceptable 2025-11-07
|
2025-11-11 |