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GEN1042 Safety Trial and Anti-tumor Activity in Participants With Malignant Solid Tumors

NCT04083599 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2026-05-06

No results posted yet for this study

Summary

The goal of this trial is to learn about the antibody GEN1042 when it is used alone and when it is used together with another antibody cancer drug, pembrolizumab (with or without chemotherapy), for treatment of participants with certain types of cancer.

Conditions

  • Malignant Solid Tumor
  • Non-Small Cell Lung Cancer (NSCLC)
  • Colorectal Cancer (CRC)
  • Melanoma
  • Head and Neck Squamous Cell Carcinoma (HNSCC)
  • Pancreatic Ductal Adenocarcinoma (PDAC)

Interventions

BIOLOGICAL

GEN1042

Intravenous

DRUG

Pembrolizumab

Intravenous

DRUG

Cisplatin

Intravenous

DRUG

Carboplatin

Intravenous

DRUG

5-FU

Intravenous

DRUG

Gemcitabine

Intravenous

DRUG

Nab paclitaxel

Intravenous

DRUG

Pemetrexed

Intravenous

DRUG

Paclitaxel

Intravenous

Sponsors & Collaborators

  • BioNTech SE

    collaborator INDUSTRY

  • Genmab

    lead INDUSTRY

Principal Investigators

  • Study Official · Genmab

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-17
Primary Completion
2025-12-30
Completion
2026-11-30
FDA Drug
Yes

Countries

  • United States
  • Denmark
  • France
  • Georgia
  • Germany
  • Israel
  • Italy
  • Moldova
  • South Korea
  • Spain
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04083599 on ClinicalTrials.gov