Recruiting

Phase 1

Phase 2

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

Sponsor:

BioInvent International AB

Code:

NCT04752826

Conditions

Advanced Malignancies

Ovarian Cancer

T-cell Lymphoma

Melanoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

BI-1808

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

Paclitaxel 80 mg/m2 weekly

Study Details

Brief 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 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

Advanced Malignancies

Ovarian Cancer

T-cell Lymphoma

Melanoma

Study ID

NCT04752826

Start date

Jan 25, 2021

Status verified date

Sep, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Jan 31, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

250 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

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

experimental: Phase 2a, Part C - Dose expansion of BI-1808 in combination with pembrolizumab and paclitaxel

BI-1808 administered in combination with pembrolizumab and paclitaxel at the respective hypothesized recommended phase 2 doses determined in Phase 1.

Interventions

BI-1808

BI-1808 administered as a flat-dose IV infusion once every 3 weeks

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

Pembrolizumab administered as a flat-dose IV infusion once every 3 weeks.

Paclitaxel 80 mg/m2 weekly

Paclitaxel administered as a flat-dose IV infusion weekly.

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. ]
Identify DLTs, determine the maximum tolerated dose and select a recommended Phase 2 dose (RP2D) of BI-1808, given via intravenous (IV) infusion, as a single agent (Phase 1, Part A), and in combination with pembrolizumab (Phase 1, Part B) [ Time Frame: Up to 104 weeks (2 years) ]
Occurrence of serious adverse events (SAEs) [ Time Frame: Up to 104 weeks (2 years) ]
To identify the recommended Phase 2 dose (RP2D) of BI-1808, [ Time Frame: up to 104 weeks (2 years) ]

Central Contacts and Locations

Central contacts

Susanne Gertsson

+46462868550 susanne.gertsson@bioinvent.com

Mona Welschof, PhD

+47 97088721 mona.welschof@bioinvent.com

Locations

City of Hope National Medical Center

Recruiting

Duarte, California, United States, 91010

Principal Investigator:

Christiane Querfeld

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10021

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Principal Investigator:

Stefan Barta

More Information

Sponsor

BioInvent International AB

Last update posted

Sep 18, 2026

Last verified

Sep, 2026

Keywords

Advanced Malignancies
T-cell Lymphoma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by BioInvent International AB on 2026-09-18. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.