Actively Recruiting
Phase 1/2a Open-Label Study of BI-1808 Alone and With Pembrolizumab in Advanced Malignancies
Led by BioInvent International AB · Updated on 2026-02-18
176
Participants Needed
25
Research Sites
54 weeks
Total Duration
On this page
Sponsors
B
BioInvent International AB
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying BI-1808, given alone or with pembrolizumab, in people with advanced cancers that have worsened after standard treatments. This early-phase trial aims to find out how safe and tolerable BI-1808 is, determine the highest dose that can be given, and select doses for future studies. The trial includes subjects with advanced solid tumors and T-cell lymphoma. Participants receive BI-1808 as an intravenous infusion every 3 weeks, either by itself or combined with pembrolizumab. The study has two main parts: Phase 1 includes dose escalation to assess safety and find recommended doses, and Phase 2a expands treatment at those doses to further evaluate safety, drug behavior in the body, and preliminary effects on tumors. During the trial, participants undergo regular assessments including monitoring for side effects, blood tests to study the drug's behavior and immune effects, and imaging to measure tumor response. Safety is followed for up to two years, with evaluations of adverse events, serious adverse events, and dosing limits. The study also examines tumor response rates and progression-free survival to understand treatment impact over time.
CONDITIONS
Brief Title
BI-1808 as a Single Agent and With Pembrolizumab (KEYTRUDA® ) in Treatment of Advanced Malignancies(Keynote-D20)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide written informed consent
- 18 years of age or older at time of consent
- Histologically confirmed advanced malignancy
- Intolerant of, refuses, or not eligible for standard antineoplastic therapy
- At least 1 measurable disease lesion per RECIST criteria
- Able to safely undergo a baseline tumor biopsy
- Life expectancy of at least 12 weeks
- ECOG performance status of 0-1
- Adequate organ function confirmed by lab tests
- Specific criteria for ovarian cancer, T-cell lymphoma, and melanoma cohorts as detailed in protocol
You will not qualify if you...
- Requires prednisolone doses over 10 mg daily (except premedication)
- Known active CNS metastases or carcinomatous meningitis
- Known or suspected hypersensitivity to BI-1808 or pembrolizumab
- Cardiac or renal amyloid light-chain amyloidosis
- Recent chemotherapy, radiotherapy, or immunotherapy within specified timeframes
- Not recovered from prior adverse events to grade 1 or better
- History of severe autoimmune reactions or current pneumonitis
- Active or suspected autoimmune disease
- Pregnant, breastfeeding, or able to become pregnant without effective contraception
- Major surgery not fully recovered from
- High medical risk from nonmalignant systemic disease or severe infections
- Chronic graft versus host disease or allogenic transplant history
- Known HIV or hepatitis infections
- Active tuberculosis history
- Recent live vaccinations
- Uncontrolled cardiovascular disease
- Psychiatric or substance abuse disorders interfering with trial participation
- Concurrent participation in another investigational trial
- Known additional malignancies except certain treated cancers
- Immunodeficiency or recent immunosuppressive therapy
- Symptomatic ascites or pleural effusion requiring intervention
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years
Participants receive BI-1808 as a single agent or in combination with pembrolizumab administered as intravenous infusions once every 3 weeks to evaluate safety, tolerability, and preliminary antitumor activity.
Infusions every 3 weeks during treatment
Duration - Up to 90 days
Participants are monitored for adverse events and safety outcomes after completion or discontinuation of treatment for up to 90 days.
Visits as needed for safety monitoring
Trial Site Locations
Total: 25 locations
1
City of Hope National Medical Center
Duarte, California, United States, 91010
Actively Recruiting
2
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10021
Actively Recruiting
3
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
4
Rigshospitalet
Copenhagen, Denmark
Actively Recruiting
5
Herlev Hospital
Herlev, Denmark, 2730
Actively Recruiting
6
PRA Health Sciences - Hungary
Budapest, Hungary, 1077
Active, Not Recruiting
7
Magyar Honvédség-Egészségügyi Központ
Budapest, Hungary, 1134
Actively Recruiting
8
Debreceni Egyetem Klinikai Központ
Debrecen, Hungary, 4032
Withdrawn
9
Byudzhetnoye Uchrezhdeniye Zdravookhraneniya Omskoy Oblasti - Klinicheskiy Onkologicheskiy Dispanser
Omsk, Russia, 644013
Terminated
10
National Medical Research Center VA Almazov
Saint Petersburg, Russia, 197022
Withdrawn
11
N.N. Petrov National Medical Research Center of Oncology
Saint Petersburg, Russia, 197758
Withdrawn
12
Institut Catala d'oncologia. Hospital Duran I Reynals
Barcelona, Spain, 08907
Not Yet Recruiting
13
Hospital General Universitario Gregorio Marañon
Madrid, Spain, 28007
Actively Recruiting
14
START Madrid - Hospital Universitario Fundación Jiménez Díaz
Madrid, Spain, 28040
Actively Recruiting
15
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Not Yet Recruiting
16
Sahlgrenska University Hospital
Gothenburg, Sweden, 41345
Actively Recruiting
17
Skanes University Hospital
Lund, Sweden, 223 70
Actively Recruiting
18
Karolinska University Hospital, Solna
Stockholm, Sweden, 17176
Actively Recruiting
19
University Hospital Birmingham
Birmingham, United Kingdom
Actively Recruiting
20
University Hospitals of Leicester NHS Trust
Leicester, United Kingdom, LE1 5WW
Actively Recruiting
21
Guy's and Saint Thomas' NHS Foundation Trust
London, United Kingdom, SE1 9RT
Actively Recruiting
22
Sarah Cannon Research Institute UK
London, United Kingdom, W1G 6AD
Actively Recruiting
23
The Royal Marsden Hospital NHS Foundation Trust
London, United Kingdom
Actively Recruiting
24
The Christie NHS Foundation Trust
Manchester, United Kingdom, M20 4BX
Actively Recruiting
25
Southampton General Hospital
Southampton, United Kingdom, SO16 6YD
Actively Recruiting
Research Team
S
Susanne Gertsson
M
Mona Welschof, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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