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A Safety Trial of GEN1042 in Japanese Subjects With Malignant Solid Tumors

NCT06057038 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2026-05-05

No results posted yet for this study

Summary

This study evaluating GEN1042 will include multiple parts. In this study, GEN1042 alone (phase 1a) or GEN1042 in combination with other anticancer drug(s) (phase 1b) will be evaluated in Japanese participants. The main purpose is to assess the safety and tolerability of GEN1042 monotherapy or GEN1042 in combination in Japanese study participants with cancer.

Conditions

  • Malignant Solid Tumor

Interventions

BIOLOGICAL

GEN1042

Intravenous

DRUG

Pembrolizumab

Intravenous

DRUG

Cisplatin

Intravenous

DRUG

Carboplatin

Intravenous

DRUG

5-Fluorouracil

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
2023-11-24
Primary Completion
2026-11-28
Completion
2026-11-28
FDA Drug
Yes

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs
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 NCT06057038 on ClinicalTrials.gov