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

RECRUITINGPHASE1/PHASE2

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

NCT04752826•BioInvent International AB

View on ClinicalTrials.gov

Summary

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),

Detailed Description

This is a Phase 1/2a, dose-escalation, multicenter, first-in-human, consecutive-cohort, open-label study of BI-1808, as a single agent and in combination with pembrolizumab in subjects with advanced malignancies, whose disease has progressed after standard therapy. The study will consist of 2 phases: a Phase 1 with Parts A and B, and a Phase 2a with Parts A and B. Phase 1 Part A consists of a dose escalation of BI-1808 as a single agent to evaluate safety and tolerability and to determine the RP2D as a single agent (sRP2D) in subjects with advanced malignancies whose disease has progressed after standard therapy. Phase 1 Part B consists of a dose escalation of BI-1808 in combination with pembrolizumab to evaluate the safety and tolerability of the combination treatment and to allow selection of the RP2D for BI-1808 in combination with pembrolizumab (cRP2D) in subjects with advanced malignancies whose disease has progressed after standard therapy. Phase 2a will assess BI-1808 administered as a single agent (Part A) and in combination with pembrolizumab (Part B) at the respective hypothesized RP2D(s) determined in Phase 1. Phase 2a expansion will be conducted in indication specific cohorts of subjects. The aim of the Phase 2a is to further assess the safety and tolerability of BI-1808 as a single agent (Part A) and in combination with pembrolizumab (Part B), characterize its PK and pharmacodynamics, and assess preliminary antitumor activity by ORR, DoR, and progression-free survival (PFS), as measured by RECIST v1.1 and iRECIST.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Is willing and able to provide written informed consent for the trial.
•2. Is ≥18 years of age on the day of signing informed consent.
•3. Has a histologically confirmed advanced malignancy. Subjects with CTCL \[MF or SS\] who satisfy the Phase 2a, Cohort 3-specific eligibility criteria may be enrolled into the Phase 1 part of the study.
•Ovarian Cancer:
•Histologically confirmed and documented recurrent ovarian, fallopian tube, and peritoneal cancer.
•TCL:
•1. histologically confirmed diagnosis
•2. Stable doses of systemic steroids (≤20 mg prednisone equivalent) and of low-to-medium potency topical steroids permitted (no change in preceding 4 weeks).
•3. Stage IB-IV with failure of at least 1 systemic therapy.
•4. No current large cell transformation for subjects with CTCL.
+9 more criteria

Exclusion Criteria

•5. Has at least 1 measurable disease lesion as defined by RECIST.
•6. Is able to safely undergo a baseline tumor tissue biopsy prior to first dose of BI-1808 (on non previously irradiated lesions only). The biopsy must be performed at least 4 weeks following the last dose of tumor directed therapy.
•7. Has a life expectancy of ≥12 weeks.
•8. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
•9. Has adequate organ function as confirmed by laboratory values.
•All Tumor Types:
•Locally advanced unresectable, recurrent or metastatic immune checkpoint inhibitor-naïve solid tumors, likely to benefit from immune checkpoint inhibitor treatment, based on Investigator opinion.
•b. Subjects must have received prior standard therapy appropriate for their tumor type and stage of disease, or in the opinion of the Investigator, would be unlikely to tolerate or derive clinical benefit from appropriate standard of care therapy.
•c. Subjects with known activation mutations must have prior target therapy.
•1. Needs doses of prednisolone \>10 mg daily (or equipotent doses of other corticosteroids) while on the trial other than as premedication.
+27 more criteria

Locations (25)

City of Hope National Medical Center

Duarte, California, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Rigshospitalet

Copenhagen, Denmark

Herlev Hospital

Herlev, Denmark

PRA Health Sciences - Hungary

Budapest, Hungary

Magyar Honvédség-Egészségügyi Központ

Budapest, Hungary

Debreceni Egyetem Klinikai Központ

Debrecen, Hungary

Byudzhetnoye Uchrezhdeniye Zdravookhraneniya Omskoy Oblasti - Klinicheskiy Onkologicheskiy Dispanser

Omsk, Russia

National Medical Research Center VA Almazov

Saint Petersburg, Russia

Key Dates

Start Date

January 25, 2021

Primary Completion Date

December 31, 2026

Completion Date

January 15, 2028

Last Updated

February 18, 2026

Enrollment

176

ESTIMATED participants

Conditions

Advanced MalignanciesOvarian CancerT-cell LymphomaMelanoma

Interventions

BI-1808

DRUG

Pembrolizumab (KEYTRUDA® ) 25 Mg/mL Solution for Injection

DRUG

Contacts

Susanne Gertsson

CONTACT

+46462868550 susanne.gertsson@bioinvent.com

Mona Welschof, PhD

CONTACT

+47 97088721 mona.welschof@bioinvent.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 18, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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