Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - First administration to humans
Status
Authorised, recruiting
Participants planned
105
Countries
4
Sites
4
Metastatic Clear Cell Renal Cell Carcinoma (ccRCC) or papillary renal cell carcinoma (pRCC) and with End-Stage Renal Disease (ESRD)
Key facts
- Sponsor
- Oncorena AB
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 24 Apr 2024 → ongoing
- Decision date (initial)
- 2026-02-20
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-505605-16-00
- EudraCT number
- 2020-005651-21
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Metastatic Clear Cell Renal Cell Carcinoma (ccRCC) or papillary renal cell carcinoma (pRCC) and with End-Stage Renal Disease (ESRD)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 22.0 | HLT | 10038443 | Renal failure and impairment | 10038359 |
| 21.1 | PT | 10050513 | Metastatic renal cell carcinoma | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Oncorena AB
- Sponsor organisation
- Oncorena AB
- Address
- Scheeletorget 1
- City
- Lund
- Postcode
- 223 63
- Country
- Sweden
Scientific contact point
- Organisation
- Oncorena AB
- Contact name
- Börje Haraldsson
Public contact point
- Organisation
- Oncorena AB
- Contact name
- Börje Haraldsson
Locations
4 EU/EEA countries · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Authorised, recruitment pending | 10 | 1 |
| Portugal | Authorised, recruiting | 10 | 1 |
| Spain | Authorised, recruitment pending | 10 | 1 |
| Sweden | Ongoing, recruiting | 75 | 1 |
| Rest of world | — | 0 | — |
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 |
|---|---|---|---|---|---|
| Portugal | 2026-03-20 | ||||
| Sweden | 2022-06-09 | 2023-06-22 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 1 · Art. 38 CTR
Temporary halt TH-19417
- Halt date
- 2024-03-19
- Planned restart
- 2024-06-19
- Member states concerned
- Sweden
- Publication date
- 2024-04-02
- Reason
- Safety related (clinical or pre-clinical results)
- Explanation
- The temporary pause in recruitment will allow us to gather information about the G5 gastrointestinal hemorrhage event in terms of causality and to consider whether additional patients should be recruited and if so, what additional safeguards should be put in place.
- Follow-up measures
- • An ad hoc dose review committee was convened to discuss the G5 gastrointestinal hemorrhage, which is being reported as a SUSAR. The dose review committee recommended a pause in recruitment of new patients to assess the events.
• Regarding the patient with G5 gastrointestinal hemorrhage, we have begun analysis of the events, including discussions with the site team and review of medical records. The patient’s family has consented to an autopsy, which has been performed.
• The dose review committee recommended that the one patient currently under treatment at the next higher dose level be given the option to continue treatment after being apprised of the status of the trial if that patient’s next scan shows benefit (i.e., lack of progression) and following implementation of an additional urgent safety measure to assure that patient’s well-being. The details of that safety measure will be specified in a subsequent document, but broadly it would include assessment of the upper gastrointestinal tract to establish a baseline for comparison, medical prophylaxis for upper GI ulceration, and additional monitoring with the goal of identifying toxicity as early as possible.
• We have communicated to the team caring for the patient currently under treatment the findings about the patient that died and asked them to be particularly vigilant for signs of upper gastrointestinal ulceration or hemorrhage or unexpected anemia. We have requested that the patient’s treatment team stay in close touch with us about the patient’s status.
• This is a temporary pause in patient recruitment. Recruitment would only resume after a substantial amendment that includes additional safeguards for patients. - Benefit-risk balance changed
- Yes
- Treatment stopped
- No
Application history
12 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-06-02 | Sweden | Acceptable 2023-06-20
|
2023-06-21 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-08-03 | Sweden | Acceptable 2023-10-04
|
2023-10-05 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-01-23 | Sweden | Acceptable 2024-04-02
|
2024-04-03 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-04-19 | Sweden | Acceptable 2024-04-23
|
2024-04-24 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-11-08 | Sweden | Acceptable 2024-12-05
|
2024-12-06 |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-03-11 | Sweden | Acceptable 2025-03-24
|
2025-03-24 |
| 7 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-05-06 | Sweden | Acceptable 2025-06-19
|
2025-06-30 |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-11-07 | Sweden | Acceptable 2025-06-19
|
2025-11-07 |
| 9 | SUBSEQUENT ADDITION OF MSC | APP-9 | 2025-11-20 | Acceptable 2025-06-19
|
2026-02-20 | |
| 10 | SUBSEQUENT ADDITION OF MSC | APP-10 | 2025-12-05 | Acceptable 2025-06-19
|
2026-01-27 | |
| 11 | SUBSEQUENT ADDITION OF MSC | APP-11 | 2026-01-30 | Acceptable 2025-06-19
|
2026-04-24 | |
| 12 | SUBSTANTIAL MODIFICATION | SM-7 | 2026-03-31 | Sweden | Acceptable | 2026-04-15 |