Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruitment ended
Participants planned
120
Countries
1
Sites
3
Urothelial cancer Esophageal cancer Gastric cancer Non-small cell lung carcinoma (NSCLC) Head and neck cancer carcinoma Ovarian carcinoma Melanoma Endometrial carcinoma
Key facts
- Sponsor
- Uswm Ct Llc
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 27 May 2020 → ongoing
- Decision date (initial)
- 2024-05-23
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-512864-71-00
- EudraCT number
- 2019-001965-34
- ClinicalTrials.gov
- NCT04044859
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Urothelial cancer Esophageal cancer Gastric cancer Non-small cell lung carcinoma (NSCLC) Head and neck cancer carcinoma Ovarian carcinoma Melanoma Endometrial carcinoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10067821 | Head and neck cancer | 100000004864 |
| 21.1 | LLT | 10053571 | Melanoma | 10029104 |
| 21.0 | LLT | 10015362 | Esophageal cancer | 10029104 |
| 21.0 | LLT | 10017760 | Gastric cancer NOS | 10029104 |
| 21.1 | LLT | 10029514 | Non-small cell lung cancer NOS | 10029104 |
| 24.1 | LLT | 10014743 | Endometrial carcinoma | 10029104 |
| 21.1 | LLT | 10077840 | Urothelial cancer of renal pelvis | 10029104 |
| 20.0 | PT | 10033128 | Ovarian cancer | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Uswm Ct Llc
- Sponsor organisation
- USWM Ct LLC
- Address
- 4441 Springdale Road
- City
- Louisville
- Postcode
- 40241-1086
- Country
- United States
Scientific contact point
- Organisation
- Adaptimmune LLC
- Contact name
- Regulatory Affairs
Public contact point
- Organisation
- Adaptimmune LLC
- Contact name
- Regulatory Affairs
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruitment ended | 32 | 3 |
| Rest of world
United States, United Kingdom, Canada
|
— | 88 | — |
Investigational sites
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 | 2020-05-27 | 2020-06-05 | 2024-09-12 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-08 | Spain | Acceptable 2024-05-23
|
2024-05-23 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-02-26 | Spain | Acceptable 2024-05-23
|
2025-02-26 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-12-18 | Spain | Acceptable 2024-05-23
|
2025-12-18 |
| 4 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-01-21 | Spain | Acceptable 2026-01-22
|
2026-01-22 |
| 5 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-03-17 | Spain | Acceptable 2026-06-08
|
2026-06-12 |