At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- BI-1808 (drug), Pembrolizumab (KEYTRUDA® ) 25 Mg/mL Solution for Injection (drug), Paclitaxel 80 mg/m2 weekly (drug)
- How long the study runs
- Study runs about 95 months (dates as stated)
- About the drug or intervention
- 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. · Paclitaxel 80 mg/m2 weekly — drug: Paclitaxel administered as a flat-dose IV infusion weekly.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 250
- Started
- 2021-01-25
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for advanced malignancies
- • Phase1/Phase2 - 250 participants
- • 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
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with advanced malignancies
Where?
- • Birmingham - University Hospital Birmingham
- • Leicester - University Hospitals of Leicester NHS Trust
- • London - Guy's and Saint Thomas' NHS Foundation Trust
- • London - Sarah Cannon Research Institute UK
- • +3 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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),
More detail
This is a Phase 1/2a, dose-escalation, multicenter, first-in-human, consecutive-cohort, open-label study of BI-1808, as a single agent, in combination with pembrolizumab, and in BI-1808 in combination with pembrolizumab and paclitaxel 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 , B and C. 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), in combination with pembrolizumab (Part B), and in combination with pembrolizumab and paclitaxel (Part C) at the respective hypothesized RP2D(s) determined in Phase 1. Phase 2a expansion will be conducted in indication specific signal seeking cohorts and indication specific Dose Optimization Cohorts) of subjects. The Phase 2a study aims to further evaluate the safety and tolerability of BI-1808 as monotherapy (Part A), in combination with pembrolizumab (Part B), and in combination with pembrolizumab and paclitaxel (Part C). Including characterization of the PK and PD profiles of BI-1808, evaluation of preliminary antitumor activity based on ORR, DoR, and progression-free survival (PFS) as assessed by RECIST v1.1 and iRECIST, and determination of the recommended Phase 2 dose (RP2D).
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Treatment history
Treatments you must have had:
- ✓ tumor or skin biopsies
What the study is looking for
- ✓Able and willing to provide written agreement to take part.
- ✓Aged 18 years or older.
- ✓confirmed by a biopsy advanced or that has spread cancer 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.
Who cannot take part
- ✗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, treatment that helps your immune system fight cancer, investigational treatment, or live vaccine within the...
- ✗History of clinically significant immune-mediated toxicity, including pneumonitis, associated with previous...
See the full criteria
Where Is This Study? (7 UK sites)
University Hospital Birmingham
Birmingham, United Kingdom
University Hospitals of Leicester NHS Trust
Leicester LE1 5WW, United Kingdom
Guy's and Saint Thomas' NHS Foundation Trust
London SE1 9RT, United Kingdom
Sarah Cannon Research Institute UK
London W1G 6AD, United Kingdom
The Royal Marsden Hospital NHS Foundation Trust
London, United Kingdom
The Christie NHS Foundation Trust
Manchester M20 4BX, United Kingdom
Southampton General Hospital
Southampton SO16 6YD, United Kingdom
How to Get in Touch
Susanne Gertsson
Sponsor contactCONTACT
Mona Welschof, PhD
Sponsor contactCONTACT