A First-in-Human, Open-label, Dose-escalation Trial With Expansion Cohorts to Evaluate Safety and Anti-tumor Activity of GEN1042 in Subjects With Malignant Solid Tumors

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-508526-10-00

Acronym

GCT1042-01

Enrollment

270

Registered

2024-06-19

Start date

2019-10-01

Completion date

Unknown

Last updated

2026-01-27

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

Conditions

advanced and/or metastatic melanoma, Head and neck squamous cell carcinoma (HNSCC), Malignant solid tumors: Patients with relapsed or refractory, Non-Small Cell Lung Cancer (NSCLC), Panctreatic ductal adenocarcinoma (PDAC) or Colorectal Cancer (CRC).

Brief summary

For dose escalation and safety run-in: • Dose-limiting toxicity (DLT) For dose expansion as monotherapy and in combination: • Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by investigator assessment

Detailed description

- Adverse events (AEs) and safety laboratory parameters - ORR per RECIST 1.1 by investigator assessment (for dose escalation only) • Duration of response (DOR) per RECIST 1.1 by investigator assessment • Disease Control Rate (DCR) per RECIST 1.1 by investigator assessment • Progression-free survival (PFS) per RECIST 1.1 by investigator assessment • OS - PK parameters and anti-drug antibodies (ADAs)

Interventions

DRUGAbraxane 5 mg/ml powder for dispersion for infusion.

DRUGCISPLATIN

DRUGPEMBROLIZUMAB

DRUGFLUOROURACIL

DRUGCARBOPLATIN

DRUGGEMCITABINE

DRUGPACLITAXEL

DRUGPEMETREXED

DRUGGEN1042 DP

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
For dose escalation and safety run-in: • Dose-limiting toxicity (DLT) For dose expansion as monotherapy and in combination: • Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by investigator assessment	—

Secondary

Measure	Time frame
- Adverse events (AEs) and safety laboratory parameters - ORR per RECIST 1.1 by investigator assessment (for dose escalation only) • Duration of response (DOR) per RECIST 1.1 by investigator assessment • Disease Control Rate (DCR) per RECIST 1.1 by investigator assessment • Progression-free survival (PFS) per RECIST 1.1 by investigator assessment • OS - PK parameters and anti-drug antibodies (ADAs)	—

Measure

Time frame

—

Countries

Denmark, France, Germany, Italy, Spain

Outcome results

None listed

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