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Taking people in SpainPhase 1/2

Tests BI-1808 alone and with pembrolizumab in advanced cancers

Tests BI-1808, an antibody, alone and with pembrolizumab in advanced cancers.

Key facts

Who runs it
BioInvent International AB
Where
Barcelona and Madrid, SpainSee the 4 sitesAlso in 6 other countries, 21 sites
Registry title
BI-1808 as a Single Agent and With Pembrolizumab (KEYTRUDA® ) in Treatment of Advanced Malignancies(Keynote-D20)
Status
Recruiting
Phase
Phase 1/2
People taking part
250 people, planned
Started
25 Jan 2021
Expected to end
31 Dec 2028
Type of study
Interventional, 5 groups
Treatments tested
  • BI-1808
  • Pembrolizumab (KEYTRUDA® ) 25 Mg/mL Solution for Injection
  • Paclitaxel 80 mg/m2 weekly
Record updated
18 September 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with advanced or metastatic cancer (solid tumors or T-cell lymphoma) whose disease got worse after standard treatment. It tests BI-1808 alone and with pembrolizumab.

Age
18 years or older
Sex
All sexes can join.
Disease stage
Advanced or metastatic cancer confirmed by tissue examination. Disease got worse after standard treatment, or standard treatment was not tolerated, not possible, or refused. For Part C: platinum-resistant high-grade serous or clear-cell ovarian cancer.
Earlier treatment
Standard treatment must have been tried, or not tolerated, not possible, or refused. Part C needs earlier platinum-based treatment as set out in the protocol. Recent cancer treatment, vaccines or trial drugs within the protocol's waiting period are not allowed.

Main reasons for not taking part

  • Active cancer spread to the brain or its covering
  • Active autoimmune disease, weak immune system, or immune-suppressing treatment
  • Earlier serious immune side effects from checkpoint inhibitor treatment, including lung inflammation
  • Earlier organ or tissue transplant, or active graft-versus-host disease
  • Pregnancy or breastfeeding

The registry criteria, word for word

Show all 25 criteriaShow less

Who can take part

  • Able and willing to provide written informed consent
  • Aged 18 years or older
  • Histologically confirmed advanced or metastatic malignancy eligible for an enrolling study cohort
  • Disease progression following, intolerance of, ineligibility for, or refusal of applicable standard therapy
  • At least one measurable lesion according to the response criteria specified in the protocol
  • Eastern Cooperative Oncology Group performance status of 0 or 1
  • Life expectancy of at least 12 weeks
  • Adequate organ function
  • Willing and medically suitable to provide required tumor or skin biopsies
  • Meets the disease-specific and treatment-history requirements of the applicable Phase 2a cohort
  • For Phase 2a Part C: Histologically confirmed platinum-resistant high-grade serous or clear-cell ovarian carcinoma, prior platinum-based treatment as specified in the protocol, and suitability for paclitaxel treatment

Who cannot take part

  • Prior treatment-related toxicity not recovered to the level specified in the protocol
  • Prior anticancer therapy, radiotherapy, immunotherapy, investigational treatment, or live vaccine within the protocol-defined washout period
  • History of clinically significant immune-mediated toxicity, including pneumonitis, associated with previous immune-checkpoint inhibitor treatment
  • Major surgery without adequate recovery
  • Prior allogeneic tissue or solid-organ transplantation or active graft-versus-host disease
  • Active or clinically significant autoimmune disease, immunodeficiency, or use of prohibited immunosuppressive treatment
  • Uncontrolled or clinically significant cardiovascular disease, serious infection, or another condition that could compromise safety or study participation
  • Known hypersensitivity to a study treatment or its components
  • Another active malignancy, except for protocol-defined permitted malignancies
  • Active central nervous system metastases or carcinomatous meningitis
  • Pregnancy or breastfeeding, or unwillingness to comply with protocol-defined contraceptive requirements
  • Participation in another interventional clinical trial that conflicts with this study
  • Unable or unlikely to comply with study procedures and requirements
  • For Phase 2a Part C: Receipt of prohibited colony-stimulating factors within the protocol-defined period before treatment

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Have you ever been told you have ovarian, fallopian tube or peritoneal cancer?
  • Have your doctors told you that your cancer is advanced (stage 3 or 4)? This means it has spread beyond the ovaries to other parts of the belly or the body, even if it was later removed by surgery.
  • Has your cancer spread to the brain or the spinal cord?

Where in Spain

Also in 6 other countries, 21 sites

  • Institut Catala d Oncologia Hospital Duran i ReynalsBarcelona, SpainContact: Susanne GertssonNot yet recruiting
  • Hospital Universitario 12 de OctubreMadrid, SpainContact: Susanne GertssonTaking people
  • Hospital Universitario Puerta de Hierro-Majadahonda, Madrid,Madrid, SpainContact: Susanne GertssonNot yet recruiting
  • START Madrid / Hospital Universitario Fundacion Jimenez DiazMadrid, SpainContact: Susanne GertssonTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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 with BI-1808 as a single agent, BI-1808 in combination with pembrolizumab and BI-1808 in combination with pembrolizumab and paclitaxel 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),

The 5 groups in the trial

  • Phase I, Part A - Dose escalation and safety of BI-1808 as single agentTreatment being tested

    Dose escalation of BI-1808 administrated a single agent

    Treatment: BI-1808

  • Phase I, Part B - Dose escalation and Safety of BI-1808 in combination with pembrolizumabTreatment being tested

    Dose escalation of BI-1808 in combination with pembrolizumab.

    Treatment: BI-1808 and Pembrolizumab (KEYTRUDA® ) 25 Mg/mL Solution for Injection

  • Phase 2a - Part A dose expansion of BI-1808 as a single agentTreatment being tested

    BI-1808 administered as a single agent at the hypothesized recommended phase 2 dose determined in Phase 1

    Treatment: BI-1808

  • Phase 2a, Part B - Dose expansion of BI-1808 in combination with pembrolizumabTreatment being tested

    BI-1808 administered in combination with pembrolizumab at the respective hypothesized recommended phase 2 doses determined in Phase 1

    Treatment: BI-1808 and Pembrolizumab (KEYTRUDA® ) 25 Mg/mL Solution for Injection

  • Phase 2a, Part C - Dose expansion of BI-1808 in combination with pembrolizumab and paclitaxelTreatment being tested

    BI-1808 administered in combination with pembrolizumab and paclitaxel at the respective hypothesized recommended phase 2 doses determined in Phase 1.

    Treatment: BI-1808, Pembrolizumab (KEYTRUDA® ) 25 Mg/mL Solution for Injection, and Paclitaxel 80 mg/m2 weekly

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
Phase 1/2a Open-Label, Dose-Escalation, Multicenter, FIH, Consecutive-Cohort, Clinical Trial of BI-1808, a Monoclonal Antibody to TNFR 2 as a Single Agent and in Combination With Pembrolizumab (MK-3475-D20) in Subjects With Advanced Malignancies
Plain-language title
Tests BI-1808 alone and with pembrolizumab in advanced cancersGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT04752826, who can take part
Record updated
18 September 2026