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

Part of paid clinical trials in Duarte, California.

Sponsor
BioInvent International AB
Study ID
NCT04752826
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BI-1808 — DRUG
    BI-1808 administered as a flat-dose IV infusion once every 3 weeks
  • Pembrolizumab (KEYTRUDA® ) 25 Mg/mL Solution for Injection — DRUG
    Pembrolizumab administered as a flat-dose IV infusion once every 3 weeks.

Study Details

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),

Key Dates

Start date
Jan 25, 2021
Status verified
Feb 2026
Primary completion
Dec 31, 2026
Completion
Jan 15, 2028

Study Design

Enrollment
176 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase I, Part A - Dose escalation and safety of BI-1808 as single agent
    Dose escalation of BI-1808 administrated a single agent
  • Experimental: Phase I, Part B - Dose escalation and Safety of BI-1808 in combination with pembrolizumab
    Dose escalation of BI-1808 in combination with pembrolizumab.
  • Experimental: Phase 2a - Part A dose expansion of BI-1808 as a single agent
    BI-1808 administered as a single agent at the hypothesized recommended phase 2 dose determined in Phase 1
  • Experimental: Phase 2a, Part B - Dose expansion of BI-1808 in combination with pembrolizumab
    BI-1808 administered in combination with pembrolizumab at the respective hypothesized recommended phase 2 doses determined in Phase 1

Primary Outcome Measure

Occurrence of adverse events (AEs) [ Time Frame: From the start of the study treatment for up to 2 years and 90 days. ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
City of Hope National Medical CenterDuarteCalifornia91010
Christiane Querfeld (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering Cancer CenterNew YorkNew York10021
Jasmine Zain
University of PennsylvaniaPhiladelphiaPennsylvania19104
Stefan Barta (PRINCIPAL_INVESTIGATOR)

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