Trials / Terminated
TerminatedNCT04725331
A Clinical Trial Assessing BT-001 Alone and in Combination With Pembrolizumab in Metastatic or Advanced Solid Tumors
A Phase I/IIa Study of Intra-tumoral BT-001 (TG6030) Administered Alone and in Combination With Pembrolizumab in Patients With Cutaneous or, Subcutaneous Lesions or Easily Injectable Lymph Nodes of Metastatic/Advanced Solid Tumors.
- Status
- Terminated
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 31 (actual)
- Sponsor
- Transgene · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a Phase I/IIa, multicenter, open-label, consecutive cohorts, dose-escalation study of BT-001 with repeated IT administrations alone and in combination with IV infusions of pembrolizumab.
Detailed description
This study will include 3 parts: * Phase I, Part A: Repeated intra-tumoral (IT) administrations of BT-001 as a single agent, in patients with metastatic/advanced solid tumors; dose-escalation will be employed. * Phase I, Part B: Repeated IT administrations of BT-001 in combination with intravenous (IV) infusions of pembrolizumab in patients with metastatic/advanced soft tissue sarcoma (STS), Merkel cell carcinoma (MCC), melanoma, triple negative breast cancer (TNBC) or non-small cell lung cancer (NSCLC).. * Phase IIa: Repeated IT administrations of BT-001 in combination with IV infusions of pembrolizumab in several cohorts of patients with defined metastatic or advanced solid tumor conditions.
Conditions
- Metastatic Cancer
- Soft Tissue Sarcoma
- Merkel Cell Carcinoma
- Melanoma
- Triple Negative Breast Cancer
- Non Small Cell Lung Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | BT-001 | Oncolytic Vaccinia virus containing genes encoding the 4-E03 human recombinant anti-hCTLA4 antibody and human GM-CSF administered at different dose \[Phase I, Part A\]; one dose lower and at Recommended Dose for Part B \[Phase I, Part B\] by intra-tumoral (IT) route. |
| DRUG | Pembrolizumab [KEYTRUDA®] | Programmed death receptor (PD-1) blocking antibody administered at 200mg by intravenous (IV) infusions every 3 weeks. |
Timeline
- Start date
- 2021-02-25
- Primary completion
- 2025-10-22
- Completion
- 2025-10-22
- First posted
- 2021-01-26
- Last updated
- 2025-11-21
Locations
5 sites across 2 countries: Belgium, France
Source: ClinicalTrials.gov record NCT04725331. Inclusion in this directory is not an endorsement.