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Phase 2 Study of Zelenectide Pevedotin in Participants with Previously-Treated NECTIN4 Amplified Advanced or Metastatic Non-small Cell Lung Cancer

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-521115-40-00
Acronym
BT8009-202
Enrollment
28
Registered
2025-09-09
Start date
2025-09-30
Completion date
Unknown
Last updated
2026-01-27

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

Conditions

Advanced or Metastatic Non-small Cell Lung Cancer

Brief summary

ORR measured by the percentage of participants who have achieved either a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 as assessed by the Investigator

Detailed description

1. Incidence of treatment-emergent adverse event(AEs) and abnormalities in laboratory, electrocardiogram (ECG) and vital signs, 2. DoR measured by the time from first documentation of objective response (that is subsequently confirmed) per RECIST v1.1 assessed by the Investigator to the first documentation of disease progression (per RECIST v1.1), or to death (due to any cause), whichever occurs first, 3. DCR measured by the percentage of participants who experience a confirmed CR, PR, or stable disease (SD) per RECIST v1.1 assessed by the Investigator, 4. CBR, defined as the proportion of participants with CR, PR or SD ≥16 weeks per RECIST v1.1 assessed by the Investigator, 5. PFS measured by the time from the first day of study drug administration (Day 1) to the first documentation of disease progression (per RECIST v1.1), or to death (due to any cause), whichever occurs first, 6. OS measured by length of time from the first day of study drug administration (Day 1) to death (due to any cause), 7. TTP defined as the time from first dose of zelenectide pevedotin until first documentation of disease progression per RECIST v.1.1 assessed by the Investigator

Interventions

Sponsors

Bicycletx Limited
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
ORR measured by the percentage of participants who have achieved either a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 as assessed by the Investigator

Secondary

MeasureTime frame
1. Incidence of treatment-emergent adverse event(AEs) and abnormalities in laboratory, electrocardiogram (ECG) and vital signs, 2. DoR measured by the time from first documentation of objective response (that is subsequently confirmed) per RECIST v1.1 assessed by the Investigator to the first documentation of disease progression (per RECIST v1.1), or to death (due to any cause), whichever occurs first, 3. DCR measured by the percentage of participants who experience a confirmed CR, PR, or stable disease (SD) per RECIST v1.1 assessed by the Investigator, 4. CBR, defined as the proportion of participants with CR, PR or SD ≥16 weeks per RECIST v1.1 assessed by the Investigator, 5. PFS measured by the time from the first day of study drug administration (Day 1) to the first documentation of disease progression (per RECIST v1.1), or to death (due to any cause), whichever occurs first, 6. OS measured by length of time from the first day of study drug administration (Day 1) to death (due to a

Countries

France, Germany, Italy, Spain

Outcome results

None listed

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