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First-In-Human, Open-Label, Dose Escalation Trial with Expansion Cohorts to Evaluate the Safety and Preliminary Efficacy of GEN1055 as Monotherapy and as Combination Therapy in Subjects with Malignant Solid Tumors.

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-507049-28-00
Acronym
GCT1055-01
Enrollment
45
Registered
2024-03-15
Start date
2024-04-16
Completion date
2025-11-20
Last updated
2025-04-09

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 Escalation Phase 1a and 1b: Incidence and severity of AEs, Dose Escalation Phase 1a and 1b: Incidence of DLTs, Expansion: According to RECIST v1.1 as assessed by investigator: ORR

Detailed description

Dose Escalation Phase 1a and 1b: PK parameters for GEN1055: • Cmax • tmax • Ctrough • AUC0-tlast • AUC0-inf • t½ • CL, Dose Escalation Phase 1a and 1b: ADA response to GEN1055 as monotherapy and as combination therapy with pembrolizumab, Dose Escalation Phase 1a and 1b: According to RECIST v1.1 as assessed by investigator: • ORR • DoR • TTR • DCR, Expansion: According to RECIST v1.1 as assessed by investigator: • DoR • TTR • DCR, Expansion: • PFS according to RECIST v1.1 as assessed by investigator • OS, Expansion: Incidence and severity of AEs, Expansion: ADA response to GEN1055 as monotherapy and as combination therapy, Expansion: PK parameters for GEN1055: • Cmax • tmax • Ctrough • AUC0-tlast • AUC0-inf • t½ • CL

Interventions

DRUGPEMETREXED DISODIUM
DRUGPEMBROLIZUMAB
DRUGPACLITAXEL
DRUGGEN1055 DP
DRUGCISPLATIN
DRUGGEMCITABINE
DRUGPACLITAXEL ALBUMIN-BOUND
DRUGCARBOPLATIN

Sponsors

Genmab A/S
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Dose Escalation Phase 1a and 1b: Incidence and severity of AEs, Dose Escalation Phase 1a and 1b: Incidence of DLTs, Expansion: According to RECIST v1.1 as assessed by investigator: ORR—

Secondary

MeasureTime frame
Dose Escalation Phase 1a and 1b: PK parameters for GEN1055: • Cmax • tmax • Ctrough • AUC0-tlast • AUC0-inf • t½ • CL, Dose Escalation Phase 1a and 1b: ADA response to GEN1055 as monotherapy and as combination therapy with pembrolizumab, Dose Escalation Phase 1a and 1b: According to RECIST v1.1 as assessed by investigator: • ORR • DoR • TTR • DCR, Expansion: According to RECIST v1.1 as assessed by investigator: • DoR • TTR • DCR, Expansion: • PFS according to RECIST v1.1 as assessed by investigator • OS, Expansion: Incidence and severity of AEs, Expansion: ADA response to GEN1055 as monotherapy and as combination therapy, Expansion: PK parameters for GEN1055: • Cmax • tmax • Ctrough • AUC0-tlast • AUC0-inf • t½ • CL—

Countries

Spain

Outcome results

None listed

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