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RECRUITING Phase 1

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

NCT04752826 · View on ClinicalTrials.gov ↗

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),

Interventions

  • DRUG BI-1808
  • DRUG Pembrolizumab (KEYTRUDA® ) 25 Mg/mL Solution for Injection

Study Locations (20)

Other

  • Rigshospitalet — Copenhagen
  • Herlev Hospital — Herlev
  • PRA Health Sciences - Hungary — Budapest
  • Magyar Honvédség-Egészségügyi Központ — Budapest
  • Debreceni Egyetem Klinikai Központ — Debrecen
  • Byudzhetnoye Uchrezhdeniye Zdravookhraneniya Omskoy Oblasti - Klinicheskiy Onkologicheskiy Dispanser — Omsk
  • National Medical Research Center VA Almazov — Saint Petersburg
  • N.N. Petrov National Medical Research Center of Oncology — Saint Petersburg
  • Institut Catala d'oncologia. Hospital Duran I Reynals — Barcelona
  • Hospital General Universitario Gregorio Marañon — Madrid
  • START Madrid - Hospital Universitario Fundación Jiménez Díaz — Madrid
  • Hospital Universitario 12 de Octubre — Madrid
  • Sahlgrenska University Hospital — Gothenburg
  • Skanes University Hospital — Lund
  • Karolinska University Hospital, Solna — Stockholm
  • University Hospital Birmingham — Birmingham
  • University Hospitals of Leicester NHS Trust — Leicester

California

  • City of Hope National Medical Center — Duarte

New York

  • Memorial Sloan Kettering Cancer Center — New York

Pennsylvania

  • University of Pennsylvania — Philadelphia

Trial Details

FieldValue
Enrollment Target 176 participants
Start Date 2021-01-25
Est. Completion 2028-01-15
Phase Phase 1

Sponsor

BioInvent International AB

3 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04752826

The ClinicalTrials.gov registry entry for NCT04752826 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 176 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is BioInvent International AB, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 4 conditions, with Ovarian Cancer appearing as the primary indexed condition, and to 2 interventions — of which BI-1808 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04752826 reports 20 study locations spanning 4 distinct geographic areas — top geographies include Other, California, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04752826 about?

NCT04752826 is a clinical study titled "BI-1808 as a Single Agent and With Pembrolizumab (KEYTRUDA® ) in Treatment of Advanced Malignancies(Keynote-D20)". 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-...

What is the current status of trial NCT04752826?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 176 participants. The study started on 2021-01-25. Estimated completion is 2028-01-15.

What conditions does trial NCT04752826 study?

This clinical trial studies the following conditions: Ovarian Cancer, Melanoma, T-cell Lymphoma, Advanced Malignancies. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04752826?

The interventions under investigation include: BI-1808 (DRUG), Pembrolizumab (KEYTRUDA® ) 25 Mg/mL Solution for Injection (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04752826?

This trial is sponsored by BioInvent International AB, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04752826 being conducted?

This trial has 20 study locations across California, New York, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial