Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ended
Participants planned
25
Countries
3
Sites
7
Metastatic solid tumors
Evaluate long-term safety in subjects with metastatic solid tumors that are benefiting from continuation of therapy with sacituzumab govitecan
Key facts
- Sponsor
- Gilead Sciences Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 8 Oct 2020 → 18 Oct 2024
- Decision date (initial)
- 2023-10-04
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Gilead Sciences, Inc.
External identifiers
- EU CT number
- 2023-505336-34-00
- EudraCT number
- 2019-004868-22
- ClinicalTrials.gov
- NCT04319198
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety
Evaluate long-term safety in subjects with metastatic solid tumors that are benefiting from continuation of therapy with sacituzumab govitecan
Conditions and MedDRA coding
Metastatic solid tumors
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10065147 | Malignant solid tumor | 10029104 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- Subjects meeting all the following inclusion criteria at Screening/Day -1 of treatment will be eligible for participation in the study.
- Female or male subjects, ≥18 years of age, able to understand and give written informed consent
- Receiving ongoing treatment with sacituzumab govitecan in a Gilead (previously Immunomedics)-sponsored parent study
- Continuing to receive clinical benefit from sacituzumab govitecan therapy
- Creatinine clearance ≥ 30 mL/min as assessed by the Cockcroft-Gault equation
- Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception as described in Appendix 5.
Exclusion criteria 6
- Subjects meeting any of the following exclusion criteria at Screening/Day -1 of treatment will not be enrolled in the study.
- Women who are pregnant or lactating (Appendix 5)
- Initiated therapy with another cancer therapeutic agent (investigational or standard of care) since receiving the last dose of the study drug on the parent study in which they participated
- Experienced a toxicity from sacituzumab govitecan that resulted in permanent discontinuation of therapy
- Have an active serious infection requiring IV antibiotics (Contact medical monitor for clarification)
- Have other concurrent medical or psychiatric conditions that, in the Investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 3
- The primary endpoints are as follows: Percentage of participants experiencing any AE.
- Percentage of participants experiencing any SAE.
- Percentage of participants experiencing any laboratory abnormality.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Trodelvy 200 mg powder for concentrate for solution for infusion
PRD9351384 · Product
- Active substance
- Sacituzumab Govitecan
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 10 mg/kg milligram(s)/kilogram
- Max total dose
- 20 mg/kg/h milligram(s)/kilogram/hour
- Max treatment duration
- 2 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01FX17 — -
- Marketing authorisation
- EU/1/21/1592/001
- MA holder
- GILEAD SCIENCES IRELAND UC
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Gilead Sciences Inc.
- Sponsor organisation
- Gilead Sciences Inc.
- Address
- 333 Lakeside Drive
- City
- Foster City
- Postcode
- 94404-1147
- Country
- United States
Scientific contact point
- Organisation
- Gilead Sciences Inc.
- Contact name
- EU CT Support
Public contact point
- Organisation
- Gilead Sciences Inc.
- Contact name
- EU CT Support
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | On site monitoring, Code 12, Code 5 |
Locations
3 EU/EEA countries · 7 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 2 | 3 |
| France | Ended | 2 | 3 |
| Spain | Ended | 1 | 1 |
| Rest of world
United States
|
— | 20 | — |
Investigational sites
UZ Leuven
-, Herestraat 49, 3000, Leuven
CHU UCL Namur
-, Place Louise Godin 15, 5000, Namur
Institut Jules Bordet
-, Mijlenmeersstraat 90, 1070, Brussels
Centre Leon Berard
-, 28 Rue Laennec, 69008, Lyon
Institut Universitaire Du Cancer Toulouse-Oncopole
-, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
Institut Bergonie
-, 229 Cours De L Argonne, 33000, Bordeaux
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 | 2020-10-23 | 2021-05-17 | 2020-11-23 | 2020-12-03 | |
| France | 2020-10-08 | 2021-11-23 | 2020-11-16 | 2020-11-16 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Summary of results Art. 37(4) CTR
| Title | Submission date | Status | Type |
|---|---|---|---|
| FINAL SUMMARY OF CLINICAL STUDY RESULTS SUM-101236
|
2025-10-08T12:17:11 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| IMIMMU-132-14_Plain Language Summary_FR | 2025-10-08T12:18:53 | Submitted | Laypersons Summary of Results |
| IMMU-132-14_Plain Language Summary_BE | 2025-10-08T12:20:11 | Submitted | Laypersons Summary of Results |
| IMMU-132-14_Plain Language Summary | 2025-10-08T12:46:53 | Submitted | Laypersons Summary of Results |
Documents 13 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Laypersons summary of results (for publication) | IMMU-132-14_Plain Language Summary | 1 |
| Laypersons summary of results (for publication) | IMMU-132-14_Plain Language Summary_BE | 1 |
| Laypersons summary of results (for publication) | IMMU-132-14_Plain Language Summary_FR | 1 |
| Protocol (for publication) | D1_Protocol_2023-505336-34_Redacted | 1.1 |
| Recruitment arrangements (for publication) | K_ES_Recruitment Arrangement_Placeholder document | 1 |
| Recruitment arrangements (for publication) | K1_FR_Recruitment Procedure_Bilingual | 1 |
| Subject information and informed consent form (for publication) | L1_ES_SIS-ICF_Main_Spanish | 4.1 |
| Subject information and informed consent form (for publication) | L1_FR_SIS-ICF_Main_French_redacted | 4.2 |
| Subject information and informed consent form (for publication) | L1_FR_SIS-ICF_Partner Pregnancy_French_redacted | 1.2 |
| Summary of results (for publication) | IMMU-132-14 CTIS Results Final_Sep 2025 | 1 |
| Synopsis of the protocol (for publication) | D1_Plain language Protocol synopsis_EN_2023-505336-34 | 1.1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ES_2023-505336-34 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_FR_2023-505336-34 | 1 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-08-10 | France | Acceptable 2023-09-29
|
2023-10-02 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-06-18 | France | Acceptable 2023-09-29
|
2024-06-18 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-07-05 | France | Acceptable 2024-09-05
|
2024-09-09 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-10-01 | 2024-10-01 |