Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Temporarily halted
Participants planned
710
Countries
4
Sites
12
Advanced or metastatic solid tumors
Key facts
- Sponsor
- Incyte Corp.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 10 Feb 2025 → ongoing
- Decision date (initial)
- 2024-10-15
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-507091-47-00
- ClinicalTrials.gov
- NCT06179160
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced or metastatic solid tumors
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10048683 | Advanced cancer | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Incyte Corp.
- Sponsor organisation
- Incyte Corp.
- Address
- 1801 Augustine Cut Off
- City
- Wilmington
- Postcode
- 19803-4404
- Country
- United States
Scientific contact point
- Organisation
- Incyte Corp.
- Contact name
- Clinical Trials Information
Public contact point
- Organisation
- Incyte Corp.
- Contact name
- Clinical Trials Information
Locations
4 EU/EEA countries · 12 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Temporarily halted | 65 | 3 |
| France | Temporarily halted | 65 | 3 |
| Italy | Temporarily halted | 65 | 3 |
| Spain | Temporarily halted | 65 | 3 |
| Rest of world
United States, Australia, Canada
|
— | 450 | — |
Investigational sites
UZ Leuven
Digestive Oncology, Herestraat 49, 3000, Leuven
Cliniques Universitaires Saint-Luc
Medical Oncology, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Antwerp University Hospital
Oncology, Drie Eikenstraat 655, 2650, Edegem
Institut Gustave Roussy
Medical Oncology, 114 Rue Edouard Vaillant, 94800, Villejuif
Centre Leon Berard
Medical Oncology, 28 Rue Laennec, 69008, Lyon
Institut Universitaire Du Cancer Toulouse-Oncopole
Medical Oncology, 1 Avenue Irene Joliot Curie, 31100, Toulouse
Centro Ricerche Cliniche Di Verona S.r.l.
Oncology Unit_ Centro Ricerche Cliniche located in the G.B. Rossi Hopital, Piazzale Ludovico Antonio Scuro 10, 37134, Verona
Humanitas Mirasole S.p.A.
Operating unit of Oncology and Hematology- Phase I Unit, Via Alessandro Manzoni 56, 20089, Rozzano
Fondazione IRCCS Istituto Nazionale Dei Tumori
Medical Oncology and Hematology, Via Giacomo Venezian 1, 20133, Milan
Hospital Universitario Fundacion Jimenez Diaz
Oncology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Universitario Quironsalud Madrid
Oncology, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
Hospital Universitari Vall D Hebron
Oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
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 |
|---|---|---|---|---|---|
| Belgium | 2025-02-10 | 2025-03-13 | 2026-02-17 | ||
| France | 2025-02-27 | 2025-03-18 | 2026-02-17 | ||
| Italy | 2025-02-26 | 2025-03-13 | 2026-02-17 | ||
| Spain | 2025-02-25 | 2025-03-17 | 2026-02-17 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 4 · Art. 38 CTR
Temporary halt TH-121518
- Halt date
- 2026-02-17
- Member states concerned
- Belgium
- Publication date
- 2026-03-02
- Reason
- Safety related (clinical or pre-clinical results)
- Explanation
- While there are confounding factors in these cases, in keeping with the highest level of commitment to patient safety, Incyte is conducting an expedited comprehensive review of safety of INCB161734 to assess the overall risk of pneumonitis/interstitial lung disease. Enrollment into the INCB161734-101 study is paused (including those participants in screening) until further notice pending completion of formal safety review.
- Follow-up measures
- Currently enrolled participants may continue study treatment at their current dose of INCB161734 after discussion with the treating physician. Ongoing participants should be notified of these events, appropriately counseled on symptoms of pneumonitis such as cough and shortness of breath, and instructed to report development of any such symptoms immediately. Protocol required safety monitoring of ongoing participants should continue as currently specified. If an ongoing participant develops symptoms concerning for pneumonitis or radiologic evidence of potential pneumonitis of any grade, INCB161734 should be immediately held as per current protocol guidance (Section 6.6.3, Table 13), and the Sponsor should be immediately notified. The Sponsor will communicate findings of the comprehensive safety review and update the ICF and IB as soon as the review is complete.
- Benefit-risk balance changed
- Yes
- Treatment stopped
- No
Temporary halt TH-121516
- Halt date
- 2026-02-17
- Member states concerned
- France
- Publication date
- 2026-03-02
- Reason
- Safety related (clinical or pre-clinical results)
- Explanation
- While there are confounding factors in these cases, in keeping with the highest level of commitment to patient safety, Incyte is conducting an expedited comprehensive review of safety of INCB161734 to assess the overall risk of pneumonitis/interstitial lung disease. Enrollment into the INCB161734-101 study is paused (including those participants in screening) until further notice pending completion of formal safety review.
- Follow-up measures
- Currently enrolled participants may continue study treatment at their current dose of INCB161734 after discussion with the treating physician. Ongoing participants should be notified of these events, appropriately counseled on symptoms of pneumonitis such as cough and shortness of breath, and instructed to report development of any such symptoms immediately. Protocol required safety monitoring of ongoing participants should continue as currently specified. If an ongoing participant develops symptoms concerning for pneumonitis or radiologic evidence of potential pneumonitis of any grade, INCB161734 should be immediately held as per current protocol guidance (Section 6.6.3, Table 13), and the Sponsor should be immediately notified. The Sponsor will communicate findings of the comprehensive safety review and update the ICF and IB as soon as the review is complete.
- Benefit-risk balance changed
- Yes
- Treatment stopped
- No
Temporary halt TH-121514
- Halt date
- 2026-02-17
- Member states concerned
- Italy
- Publication date
- 2026-03-02
- Reason
- Safety related (clinical or pre-clinical results)
- Explanation
- While there are confounding factors in these cases, in keeping with the highest level of commitment to patient safety, Incyte is conducting an expedited comprehensive review of safety of INCB161734 to assess the overall risk of pneumonitis/interstitial lung disease. Enrollment into the INCB161734-101 study is paused (including those participants in screening) until further notice pending completion of formal safety review.
- Follow-up measures
- Currently enrolled participants may continue study treatment at their current dose of INCB161734 after discussion with the treating physician. Ongoing participants should be notified of these events, appropriately counseled on symptoms of pneumonitis such as cough and shortness of breath, and instructed to report development of any such symptoms immediately. Protocol required safety monitoring of ongoing participants should continue as currently specified. If an ongoing participant develops symptoms concerning for pneumonitis or radiologic evidence of potential pneumonitis of any grade, INCB161734 should be immediately held as per current protocol guidance (Section 6.6.3, Table 13), and the Sponsor should be immediately notified. The Sponsor will communicate findings of the comprehensive safety review and update the ICF and IB as soon as the review is complete.
- Benefit-risk balance changed
- Yes
- Treatment stopped
- No
Temporary halt TH-121512
- Halt date
- 2026-02-17
- Member states concerned
- Spain
- Publication date
- 2026-03-02
- Reason
- Safety related (clinical or pre-clinical results)
- Explanation
- While there are confounding factors in these cases, in keeping with the highest level of commitment to patient safety, Incyte is conducting an expedited comprehensive review of safety of INCB161734 to assess the overall risk of pneumonitis/interstitial lung disease. Enrollment into the INCB161734-101 study is paused (including those participants in screening) until further notice pending completion of formal safety review.
- Follow-up measures
- Currently enrolled participants may continue study treatment at their current dose of INCB161734 after discussion with the treating physician. Ongoing participants should be notified of these events, appropriately counseled on symptoms of pneumonitis such as cough and shortness of breath, and instructed to report development of any such symptoms immediately. Protocol required safety monitoring of ongoing participants should continue as currently specified. If an ongoing participant develops symptoms concerning for pneumonitis or radiologic evidence of potential pneumonitis of any grade, INCB161734 should be immediately held as per current protocol guidance (Section 6.6.3, Table 13), and the Sponsor should be immediately notified. The Sponsor will communicate findings of the comprehensive safety review and update the ICF and IB as soon as the review is complete.
- Benefit-risk balance changed
- Yes
- Treatment stopped
- No
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-28 | Italy | Acceptable 2024-10-14
|
2024-10-14 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-12-17 | Acceptable | 2025-01-10 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-03-28 | Italy | Acceptable 2025-07-07
|
2025-07-07 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-08-20 | Italy | Acceptable with conditions 2025-12-09
|
2025-12-09 |