First-in-Human, Open-label, Dose-Escalation Trial with Expansion Cohorts to Evaluate the Safety of GEN1053 as Monotherapy and in Combination With an Immunomodulator in Subjects with Malignant Solid Tumors

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-502419-12-00

Acronym

GCT1053-01

Enrollment

Registered

2023-01-30

Start date

2022-11-02

Completion date

2024-05-23

Last updated

2024-07-02

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

Conditions

Malignant Solid Tumors

Brief summary

Dose-limiting toxicities (DLTs; Dose Escalation parts only), Adverse events (AEs) and safety laboratory parameters

Detailed description

PK parameters: clearance, volume of distribution, maximum concentration, time of Cmax, predose trough concentrations, half-life, area under the concentration-time curve, Antidrug antibody response of GEN1053 and in combination with IM, Antitumor activity according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1: objective response rate (ORR), disease control rate (DCR), duration of response (DoR)

Interventions

DRUGHexaBody-CD27

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Dose-limiting toxicities (DLTs; Dose Escalation parts only), Adverse events (AEs) and safety laboratory parameters	—

Secondary

Measure	Time frame
PK parameters: clearance, volume of distribution, maximum concentration, time of Cmax, predose trough concentrations, half-life, area under the concentration-time curve, Antidrug antibody response of GEN1053 and in combination with IM, Antitumor activity according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1: objective response rate (ORR), disease control rate (DCR), duration of response (DoR)	—

Measure

Time frame

—

Countries

Spain

Outcome results

None listed

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