Clinical trial · Interventional
BI-1808 as a Single Agent and With Pembrolizumab (KEYTRUDA® ) in Treatment of Advanced Malignancies(Keynote-D20)
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 19, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260919-000001
Summary
Brief summary (as posted)
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 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),
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Malignancies | Ovarian Neoplasm | PROBABILISTIC | 0.70 |
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| T-cell Lymphoma | T-Cell Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BI-1808 | Drug | — | UNRESOLVED |
| Paclitaxel 80 mg/m2 weekly | Drug | Paclitaxel | ALIAS |
| Pembrolizumab (KEYTRUDA® ) 25 Mg/mL Solution for Injection | Drug | Pembrolizumab | ALIAS |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- Phase I, Part A - Dose escalation and safety of BI-1808 as single agent
- description
- Dose escalation of BI-1808 administrated a single agent
- interventionNames
- Drug: BI-1808
- type
- EXPERIMENTAL
- label
- Phase I, Part B - Dose escalation and Safety of BI-1808 in combination with pembrolizumab
- description
- Dose escalation of BI-1808 in combination with pembrolizumab.
- interventionNames
- Drug: BI-1808
- Drug: Pembrolizumab (KEYTRUDA® ) 25 Mg/mL Solution for Injection
- type
- EXPERIMENTAL
- label
- Phase 2a - Part A dose expansion of BI-1808 as a single agent
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: 1\. Active central nervous system metastases or carcinomatous meningitis. * Active or clinically significant autoimmune disease, immunodeficiency, or use of prohibited immunosuppressive treatment. * 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. * Uncontrolled or clinically significant cardiovascular disease, serious infection, or another condition that could compromise safety or study participation. * Major surgery without adequate recovery. * Prior allogeneic tissue or solid-organ transplantation or active graft-versus-host disease. * Pregnancy or breastfeeding, or unwillingness to comply with protocol-defined contraceptive requirements. * Known hypersensitivity to a study treatment or its components. * Another active malignancy, except for protocol-defined permitted malignancies. * 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.
References
Publications (0)
Data not yet available