GEN1042 Trial of Safety and Anti-tumor Activity in Subjects with Malignant Solid Tumors

Phase 1

• Conditions: Malignant solid tumors:Patients with relapsed or refractory, advanced and/or metastatic melanoma, Non-Small Cell Lung Cancer (NSCLC) or Colorectal Cancer (CRC) who are not anymore candidates for standard therapy, Head and Neck Squamous Cell Carcinoma (HNSCC) and pancreatic ductal adenocarcinoma (PDAC); MedDRA version: 21.1Level: LLTClassification code 10065143Term: Malignant solid tumourSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2018-003716-47-IT
• Lead Sponsor: GENMAB A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-02-08
• Last Update Posted: 28 August 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 647

Inclusion Criteria

- Monotherapy
- Combination Therapy

As defined in the protocol section Inclusion criteria
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 301
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 346

Exclusion Criteria

- Monotherapy
- Combination Therapy

As defined in the protocol section Exclusion criteria

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified