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.
Study 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),
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Occurrence of adverse events (AEs) — From the start of the study treatment for up to 2 years and 90 days. AEs will be assessed by the investigators by severity and will be graded according to the NCI CTCAE v5.0 or higher and causality between AEs and the exposure to the study treatment.
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) — Up to 104 weeks (2 years) Determine the hypothesized RP2D dose for BI-1808 Phase 2a according to mTPI-2 design
Occurrence of serious adverse events (SAEs) — Up to 104 weeks (2 years) SAEs will be assessed by the investigators by severity and will be graded according to the NCI CTCAE v5.0 or higher and causality between SAEs and the exposure to the study treatment
To identify the recommended Phase 2 dose (RP2D) of BI-1808, — up to 104 weeks (2 years) Select the RP2D dose for BI-1808 derived from the totality of PK, PD, clinical response, safety,and tolerability observed in signal seeking and dose optimization cohorts.
Trial sites (25)
Facility
City
Region
Status
City of Hope National Medical Center
Duarte
California
Recruiting
Memorial Sloan Kettering Cancer Center
New York
New York
Recruiting
University of Pennsylvania
Philadelphia
Pennsylvania
Recruiting
Rigshospitalet
Copenhagen
Denmark
Recruiting
Herlev Hospital
Herlev
Denmark
Recruiting
PRA Health Sciences - Hungary
Budapest
Hungary
Active Not Recruiting
Magyar Honvédség-Egészségügyi Központ
Budapest
Hungary
Recruiting
Debreceni Egyetem Klinikai Központ
Debrecen
Hungary
Withdrawn
Byudzhetnoye Uchrezhdeniye Zdravookhraneniya Omskoy Oblasti - Klinicheskiy Onkologicheskiy Dispanser
Omsk
Russia
Terminated
National Medical Research Center VA Almazov
Saint Petersburg
Russia
Withdrawn
N.N. Petrov National Medical Research Center of Oncology
Saint Petersburg
Russia
Withdrawn
Institut Catala d'oncologia. Hospital Duran I Reynals
Barcelona
Spain
Not Yet Recruiting
Hospital Universitario Puerta de Hierro-Majadahonda, Madrid,
Madrid
Spain
Not Yet Recruiting
START Madrid - Hospital Universitario Fundación Jiménez Díaz
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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