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GEN1046 Safety and PK in Subjects With Advanced Solid Malignancies

NCT04937153 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2025-07-16

No results posted yet for this study

Summary

The primary objective of the study is to evaluate the safety, tolerability, dose-limiting toxicity (DLT) and pharmacokinetics (PK) of acasunlimab (also known as GEN1046) administered as monotherapy or in combination with pembrolizumab in Japanese study participants with malignant solid tumors.

Conditions

Interventions

BIOLOGICAL

Acasunlimab

Acasunlimab will be administered intravenously (IV) once every 21 days.

BIOLOGICAL

Pembrolizumab

Pembrolizumab will be administered IV once every 21 days.

Sponsors & Collaborators

  • Genmab

    lead INDUSTRY

Principal Investigators

  • Study Official · Genmab

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-15
Primary Completion
2024-10-01
Completion
2024-10-01
FDA Drug
Yes

Countries

  • Japan

Study Locations

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Entities

Drugs
Diseases

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 NCT04937153 on ClinicalTrials.gov