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BI-1808 as a Single Agent and With Pembrolizumab (KEYTRUDA® ) in Treatment of Advanced Malignancies(Keynote-D20)

NCT04752826 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 176

Last updated 2026-02-18

No results posted yet for this study

Summary

The goal of this first in human clinical trial is to test BI-1808 administered as single agent and in combination with pembrolizumab in subjects with advanced malignancies whose disease has progressed after standard therapy.

The main questions it aims to answer are:

* how safe and tolerable is BI-1808
* what is maximum tolerated or administrated dose
* to determine recommended dose for further clinical trials. Participants will receive infusions of BI-1808 alone or combination with pembrolizumab every 3 weeks.

For the purpose of this study, subjects with advanced malignancies includes subjects with advanced solid tumors and subjects with T-cell lymphoma (TCL),

Conditions

Interventions

DRUG

BI-1808

BI-1808 administered as a flat-dose IV infusion once every 3 weeks

DRUG

Pembrolizumab (KEYTRUDA® ) 25 Mg/mL Solution for Injection

Pembrolizumab administered as a flat-dose IV infusion once every 3 weeks.

Sponsors & Collaborators

Principal Investigators

  • Andres McAllister, PhD · BioInvent International AB

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-25
Primary Completion
2026-12-31
Completion
2028-01-15
FDA Drug
Yes

Countries

  • United States
  • Denmark
  • Hungary
  • Russia
  • Spain
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

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 NCT04752826 on ClinicalTrials.gov