A Phase 2 Exploratory, Multicenter, Open-Label Trial to Determine the Safety and Preliminary Clinical Activity of GEN1046 in Combination With Anticancer Agents in Subjects With Advanced Endometrial Cancer

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-502453-33-00

Acronym

GCT1046-05

Enrollment

Registered

2023-07-27

Start date

2024-02-26

Completion date

2024-04-22

Last updated

2024-03-26

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

Conditions

Advanced Endometrial Cancer

Brief summary

Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 as assessed by the investigator

Detailed description

Per RECIST 1.1 as assessed by the investigator: • Duration of response (DOR) • Time to response (TTR) • Disease control rate (DCR), • Incidence and severity of adverse events (AEs) • Incidence and severity of laboratory abnormalities

Interventions

DRUGDuoBody®-PD-L1x4-1BB

DRUGKEYTRUDA 25 mg/mL 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) per Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 as assessed by the investigator	—

Secondary

Measure	Time frame
Per RECIST 1.1 as assessed by the investigator: • Duration of response (DOR) • Time to response (TTR) • Disease control rate (DCR), • Incidence and severity of adverse events (AEs) • Incidence and severity of laboratory abnormalities	—

Countries

Belgium, Denmark, Italy, Poland, Spain

Outcome results

None listed

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