A Clinical Trial Assessing BT-001 Alone and in Combination With Pembrolizumab in Metastatic or Advanced Solid Tumors
← catalyst calendarSponsored by Transgene (industry) · TNG.PA — their whole pipeline →. With BioInvent International AB, Merck Sharp & Dohme LLC.
Phase
Phase 1/2
Status
Terminated
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
31actual
Sites
5
Countries
Belgium, France
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Why the sponsor stopped it
Sponsor decision following completion of Phase I part not driven by safety reason
As filed on the registry record, in the sponsor's own words.
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2021-02-25 | actual | When the study began enrolling |
| Primary completion | 2025-10-22 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-10-22 | actual | The whole study's end, after follow-up |
| First posted | 2021-01-26 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-11-21 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Metastatic Cancer
- Soft Tissue Sarcoma
- Merkel Cell Carcinoma
- Melanoma
- Triple Negative Breast Cancer
- Non Small Cell Lung Cancer
Interventions
- Biological: BT-001
- Drug: Pembrolizumab [KEYTRUDA®] — also filed as KEYTRUDA®
Primary outcomes
what the primary-completion date above is the date OFPhase I: Safety and tolerability (Adverse Event reported per NCI-CTCAE v5.0)
measured Up to 5 years
Phase I, Part A: Recommended dose for Part B (RDPB) definition
measured Week 10-12
Phase IIa (except Soft Tissue Sarcoma cohort): Immune Overall Response Rate (iORR) by iRECIST
measured Up to 2 years
Phase IIa (Soft Tissue Sarcoma cohort): Immune Disease Control Rate (iDCR) at 6 months by iRECIST
measured Up to 6 months
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