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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
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-518529-14-00
Acronym
BT-001.01
Enrollment
30
Registered
2024-12-04
Start date
2021-02-26
Completion date
2025-10-22
Last updated
2025-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

melanoma, Merkel cell carcinoma (MCC), Metastatic/advanced soft tissue sarcoma (STS), triple negative breast cancer (TNBC) or non-small cell lung cancer (NSCLC).

Brief summary

Phase I part: Overall incidence of AEs and DLTs, SAEs, Phase IIa part - Soft Tissue Sarcoma cohort: Progression Free Rate at 6-months according to iRECIST, Phase IIa part - All cohorts except Soft Tissue Sarcoma : Immune Overall Response Rate according to iRECIST.

Detailed description

Overall incidence of AEs and DLTs, SAEs (Phase IIa part), Disease Control rate overall and at 4-month using RECIST 1.1 and iRECIST, Progression Free Survival using RECIST 1.1 and iRECIST, Overall Survival

Interventions

DRUGPEMBROLIZUMAB
DRUGBT-001
DRUGTG6030
DRUGVaccinia Immunoglobulin Intravenous (Human) [VIGIV]

Sponsors

Transgene
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Phase I part: Overall incidence of AEs and DLTs, SAEs, Phase IIa part - Soft Tissue Sarcoma cohort: Progression Free Rate at 6-months according to iRECIST, Phase IIa part - All cohorts except Soft Tissue Sarcoma : Immune Overall Response Rate according to iRECIST.

Secondary

MeasureTime frame
Overall incidence of AEs and DLTs, SAEs (Phase IIa part), Disease Control rate overall and at 4-month using RECIST 1.1 and iRECIST, Progression Free Survival using RECIST 1.1 and iRECIST, Overall Survival

Countries

Belgium, France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026