Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
100
Countries
1
Sites
8
Advanced solid tumors
Key facts
- Sponsor
- Zai Lab (Shanghai) Co. Ltd.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 10 Mar 2025 → 28 Aug 2025
- Decision date (initial)
- 2023-08-28
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced solid tumors
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10065147 | Malignant solid tumor | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Zai Lab (Shanghai) Co. Ltd.
- Sponsor organisation
- Zai Lab (Shanghai) Co. Ltd.
- Address
- South Building Building 1 F 4, No. 4560 Jinke Road, Trade Zone No. 4560 Jinke Road Trade Zone
- City
- Pilot Free
- Postcode
- 201210
- Country
- China
Scientific contact point
- Organisation
- Zai Biopharmaceutical (Suzhou) Co. Ltd.
- Contact name
- Nehal Parikh
Public contact point
- Organisation
- Zai Biopharmaceutical (Suzhou) Co. Ltd.
- Contact name
- Guanying Wang
Locations
1 EU/EEA country · 8 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ended | 40 | 8 |
| Rest of world
China, United States
|
— | 60 | — |
Investigational sites
Fundacion Instituto Valenciano De Oncologia
Oncology Department, Calle Professor Beltran Baguena 8, 46009, Valencia
Hospital Universitario Hm Sanchinarro
Oncology Department, Calle Ona 10, 28050, Madrid
Hospital Quironsalud Barcelona
Oncology Department, Placa D'alfonso Comin 5-7, 08023, Barcelona
Hospital Clinico Universitario De Valencia
Oncology Department, Avenida Blasco Ibanez 17, 46010, Valencia
Hospital Universitario Quironsalud Madrid
Oncology Department, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
Hospital Universitario Virgen De La Macarena
Oncology Department, Avenida Del Doctor Fedriani 3, 41009, Sevilla
Hospital Universitario Fundacion Jimenez Diaz
Oncology Department, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Universitari Vall D Hebron
Oncology Department, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, 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 |
|---|---|---|---|---|---|
| Spain | 2023-09-12 | 2023-09-28 | 2025-08-18 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 2 · Art. 38 CTR
Temporary halt TH-46318
- Halt date
- 2024-09-10
- Member states concerned
- Spain
- Publication date
- 2024-09-16
- Reason
- Sponsor decision, Safety related (clinical or pre-clinical results), Medicinal Product related
- Explanation
- The Sponsor has temporarily halted new patient enrollments for ZL-1218 in monotherapy and in combination-therapy with pembrolizumab following pre-specified Study Stopping Rules in protocol version 4, section 6.4: “The clinical study will be halted for safety analysis if there are two Grade 4 toxicities or one Grade 5 toxicity that are at least possibly related to the investigational agent, and notification will be provided to the relevant health authorities as well as the respective IRB/IEC as required.”
- Follow-up measures
- For the patients who continue to receive the study treatment, ZL-1218 dosing must be switched from a schedule of every 21 days (every 3 weeks) to a schedule of every 63 days (every 9 weeks). For all patients currently in the Combination cohort, the pembrolizumab dosing will not change.
- Benefit-risk balance changed
- Yes
- Treatment stopped
- No
Temporary halt TH-46305
- Halt date
- 2024-09-10
- Member states concerned
- Spain
- Publication date
- 2024-09-16
- Reason
- Sponsor decision, Safety related (clinical or pre-clinical results), Medicinal Product related
- Explanation
- The Sponsor has temporarily halted new patient enrollments for ZL-1218 in monotherapy and in combination-therapy with pembrolizumab following pre-specified Study Stopping Rules in protocol version 4, section 6.4: “The clinical study will be halted for safety analysis if there are two Grade 4 toxicities or one Grade 5 toxicity that are at least possibly related to the investigational agent, and notification will be provided to the relevant health authorities as well as the respective IRB/IEC as required.”
- Follow-up measures
- For the patients who continue to receive the study treatment, ZL-1218 dosing must be switched from a schedule of every 21 days (every 3 weeks) to a schedule of every 63 days (every 9 weeks). For all patients currently in the Combination cohort, the pembrolizumab dosing will not change.
- Benefit-risk balance changed
- Yes
- Treatment stopped
- No
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-05-30 | Spain | Acceptable 2023-08-28
|
2023-08-28 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-03-22 | Spain | Acceptable 2024-05-10
|
2024-05-10 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-09-26 | Spain | Acceptable | 2024-11-04 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-12-20 | Spain | Acceptable 2025-01-15
|
2025-01-15 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-01-24 | Spain | Acceptable 2025-03-10
|
2025-03-10 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-04-01 | Spain | Acceptable 2025-03-10
|
2025-04-01 |