A Phase 2 Open-Label Study of Sacituzumab Govitecan (IMMU-132) in Subjects with Metastatic Solid Tumors

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-513611-28-00

Acronym

IMMU-132-11

Enrollment

Registered

2024-07-12

Start date

2022-07-29

Completion date

Unknown

Last updated

2025-10-23

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

Conditions

Metastatic Solid Tumors

Brief summary

Objective response rate (ORR) according to RECIST 1.1 by Investigator's assessment.

Detailed description

ORR, DOR, CBR, and PFS according to RECIST 1.1 by BICR., DOR, CBR, and PFS, according to RECIST 1.1 by Investigator's assessment., Overall survival (OS)., Incidence of treatment-emergent adverse events (AEs) and clinical laboratory abnormalities., Serum concentrations of sacituzumab govitecan over time and incidence of anti-drug antibody (ADA) to sacituzumab govitecan.

Interventions

DRUGTrodelvy 200 mg powder for concentrate for solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Objective response rate (ORR) according to RECIST 1.1 by Investigator's assessment.	—

Secondary

Measure	Time frame
ORR, DOR, CBR, and PFS according to RECIST 1.1 by BICR., DOR, CBR, and PFS, according to RECIST 1.1 by Investigator's assessment., Overall survival (OS)., Incidence of treatment-emergent adverse events (AEs) and clinical laboratory abnormalities., Serum concentrations of sacituzumab govitecan over time and incidence of anti-drug antibody (ADA) to sacituzumab govitecan.	—

Countries

Belgium, France, Spain

Outcome results

None listed

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