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Study of Safety and Antitumor Activity of GEN1056 in Participants With Advanced Solid Tumors

NCT05586321 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2025-11-24

No results posted yet for this study

Summary

The main purpose of this first-in-human study of GEN1056, is to evaluate safety. In addition, the study will determine the recommended dose and frequency for subsequent clinical studies and will assess the preliminary anti-tumor activity of GEN1056. GEN1056 will be studied in patients with advanced or metastatic solid cancer, for whom standard of care (SOC) therapy is not an option. All participants will get GEN1056.

Conditions

  • Solid Tumor, Adult

Interventions

BIOLOGICAL

GEN1056

GEN1056 will be administered as an intravenous (IV) infusion. The dose levels will be determined by the starting dose and the escalation steps taken in the trial in Part 1. In Part 2, the dose and schedule will be decided based on data outcome from Part 1.

Sponsors & Collaborators

  • BioNTech SE

    collaborator INDUSTRY

  • Genmab

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-24
Primary Completion
2025-10-23
Completion
2025-10-23

Countries

  • Georgia
  • Moldova
  • Spain

Study Locations

More Related Trials

Entities

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 NCT05586321 on ClinicalTrials.gov