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A Phase 1 Dose Finding and Phase 2 Randomized, Open-Label Trial to Evaluate the Safety and Clinical Activity of Immunoradiotherapy Combinations as a Treatment Option for Subjects With Metastatic Solid Tumors

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-508529-29-00
Acronym
GCT1042-02
Enrollment
88
Registered
2024-08-07
Start date
2023-03-08
Completion date
2025-08-11
Last updated
2025-03-24

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

Conditions

Metastatic Solid Malignant tumors

Brief summary

Part 1: Dose Limiting Toxicities (DLTs), Part 2: Number of Participants with Abscopal Response in Non-irradiated Target Lesions

Detailed description

Parts 1 and 2: Objective Response Rate (ORR) per RECIST v1.1 as assessed by investigator., Parts 1 and 2: Duration of Response (DOR) per RECIST v1.1 as assessed by investigator., Parts 1 and 2: Disease Control Rate (DCR) per RECIST v1.1 as assessed by investigator., Parts 1 and 2: Progression Free Survival (PFS) per RECIST v1.1 as assessed by investigator., Parts 1 and 2: Overall Survival (OS), Part 1: Number of Participants With Abscopal Response in Non-irradiated Target Lesions, Parts 1 and 2: Incidence and severity Adverse Events (AEs) and safety laboratory parameters., Parts 1 and 2: Pharmacokinetics (PK) parameter, Parts 1 and 2: Number of Participants with Anti-drug Antibodies (ADAs)

Interventions

DRUGGEN1042 DP
DRUGPEMBROLIZUMAB

Sponsors

Genmab A/S
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Part 1: Dose Limiting Toxicities (DLTs), Part 2: Number of Participants with Abscopal Response in Non-irradiated Target Lesions—

Secondary

MeasureTime frame
Parts 1 and 2: Objective Response Rate (ORR) per RECIST v1.1 as assessed by investigator., Parts 1 and 2: Duration of Response (DOR) per RECIST v1.1 as assessed by investigator., Parts 1 and 2: Disease Control Rate (DCR) per RECIST v1.1 as assessed by investigator., Parts 1 and 2: Progression Free Survival (PFS) per RECIST v1.1 as assessed by investigator., Parts 1 and 2: Overall Survival (OS), Part 1: Number of Participants With Abscopal Response in Non-irradiated Target Lesions, Parts 1 and 2: Incidence and severity Adverse Events (AEs) and safety laboratory parameters., Parts 1 and 2: Pharmacokinetics (PK) parameter, Parts 1 and 2: Number of Participants with Anti-drug Antibodies (ADAs)—

Countries

France

Outcome results

None listed

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