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-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 subje

Trial Details

NCT ID
NCT04752826
Phase
PHASE1 / PHASE2
Sponsor
BioInvent International AB
Status
RECRUITING
Cancer Type
Melanoma
Interventions
  • BI-1808
  • Pembrolizumab (KEYTRUDA® ) 25 Mg/mL Solution for Injection
Locations (sample)
  • Duarte, California, United States|34.13945,-117.97729
  • New York, New York, United States|40.71427,-74.00597
  • Philadelphia, Pennsylvania, United States|39.95238,-75.16362
  • Copenhagen, Denmark|55.67594,12.56553
  • Herlev, Denmark|55.72366,12.43998

Key Eligibility Criteria

  • Is willing and able to provide written informed consent for the trial.
  • Is ≥18 years of age on the day of signing informed consent.
  • Has a histologically confirmed advanced malignancy. Subjects with CTCL \[MF or SS\] who satisfy the Phase 2a, Cohort 3-specific eligibility criteri…
  • Is intolerant of, refuses, or is not eligible for standard antineoplastic therapy.

For full eligibility, visit ClinicalTrials.gov.

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