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New treatment option for Advanced Malignancies
Official title BI-1808 as a Single Agent and With Pembrolizumab (KEYTRUDA® ) in Treatment of Advanced Malignancies(Keynote-D20)
ClinicalTrials.gov ID: NCT04752826
What this study is testing
What is BI-1808?
BI-1808 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for advanced malignancies.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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. people with CTCL [MF or SS] who satisfy the Phase 2a, Cohort 3-specific eligibility criteria may...
- Is intolerant of, refuses, or is not eligible for standard antineoplastic therapy.
- Has at least 1 measurable disease lesion as defined by RECIST.
You likely can't join if
- Needs doses of prednisolone \>10 mg daily (or equipotent doses of other corticosteroids) while on the trial other than as premedication.
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Has known or suspected hypersensitivity to BI-1808 or pembrolizumab
- Has cardiac or renal amyloid light-chain amyloidosis.
- Has received the following:
- Chemotherapy or small molecule products within 4 weeks of first dose of BI-1808.
See the full eligibility criteria
Who can join
- 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. people 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.
- Is intolerant of, refuses, or is not eligible for standard antineoplastic therapy.
- Has at least 1 measurable disease lesion as defined by RECIST.
- 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...
- Has a life expectancy of ≥12 weeks.
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Has adequate organ function as confirmed by laboratory values. Phase 2a Expansion Cohort-Specific Ovarian Cancer: Histologically confirmed and documented recurrent ovarian, fallopian tube, and peritoneal cancer. TCL:
- histologically confirmed diagnosis
- Stable doses of systemic steroids (≤20 mg prednisone equivalent) and of low-to-medium potency topical steroids permitted (no change in preceding 4 weeks).
- Stage IB-IV with failure of at least 1 systemic therapy.
- No current large cell transformation for people with CTCL.
- Prior therapy - No prior allo hematopoietic stem cell transplantation (HSCT); \>90 days since auto HSCT; \>4 weeks since systemic therapy and \>2 weeks since skin-directed therapy.
- Stable doses of systemic steroids (≤20 mg prednisone equivalent) and of low-to-medium potency topical steroids permitted (no change in preceding 4 weeks).
- Previous systemic therapies include brentuximab vedotin, bexarotene, extracorporeal photopheresis (ECP), methotrexate, mogamulizumab, romidepsin, vorinostat, or systemic therapy with localized radiation treatment or...
- Histologically confirmed diagnosis of unresectable or metastatic melanoma. people in Part A:
- Required prior therapies will include anti-programmed death-ligand 1 (PD-1) therapy either as monotherapy or as part of a combination regimen.
- For people with a known BRAF V600-activating mutation combination targeted therapy will be required in addition to anti-PD-1/programmed death-ligand 1 (PD-L1) therapy. people in part B:
- people with prior lines of treatment are not eligible. All Tumor Types: Locally advanced unresectable, recurrent or metastatic immune checkpoint inhibitor-naïve solid tumors, likely to benefit from immune checkpoint...
What rules you out
- Needs doses of prednisolone \>10 mg daily (or equipotent doses of other corticosteroids) while on the trial other than as premedication.
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Has known or suspected hypersensitivity to BI-1808 or pembrolizumab
- Has cardiac or renal amyloid light-chain amyloidosis.
- Has received the following:
- Chemotherapy or small molecule products within 4 weeks of first dose of BI-1808.
- Radiotherapy within 2 weeks of first dose of BI-1808. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) for non-CNS disease. people who have previously had radiation pneumonitis are not...
- Immunotherapy within 4 weeks prior to the first dose of BI-1808.
- Has not recovered from AEs to at least Grade 1 by NCI CTCAE
- Has had Grade ≥3 autoimmune manifestations of previous immune checkpoint inhibitor treatments (eg, anti-PD-1, anti-PD-L1, or anti-CTLA-4).
- Has a history of (noninfectious) pneumonitis that required steroids or has current pneumonitis.
- Has an active, known, or suspected autoimmune disease.
- Is a female subject and has the ability to become pregnant (or already pregnant or lactating/breastfeeding). However, those female people who have a negative serum or urine pregnancy test before enrollment and agree to...
- Is a male subject with partner(s) of childbearing potential (unless he agrees to take measures not to father children by using 1 form of highly effective contraception [condom plus spermicide gel] during the trial and...
- Has had major surgery from which the subject has not yet recovered.
- Is at high medical risk because of nonmalignant systemic disease including severe active infections on treatment with antibiotics, antifungals, or antivirals.
- Has presence of chronic graft versus host disease.
- Has had an allogenic tissue/solid organ transplant.
- Has known human immunodeficiency (HIV) and/or history of hepatitis B or C infections, or has a positive test for HIV antibody, hepatitis B antigen/hepatitis B virus DNA or hepatitis C antibody or RNA.
- Has a history of active tuberculosis (Bacillus tuberculosis).
- Has received a live vaccine within 30 days before the first dose of study treatment.
- Has uncontrolled or significant cardiovascular disease.
- Has a known psychiatric or substance abuse disorder that would interfere with the subject's ability to cooperate with the requirements of the trial.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is...
- Is participating or planning to participate in another treatment clinical trial, or has participated in a trial of an investigational agent or has used an investigational device within 4 weeks prior to first dose of...
- Has a known additional malignancy of another type, with the exception of adequately treated cone biopsied carcinoma in situ (eg, breast carcinoma, cervical cancer in situ) and basal or squamous cell carcinoma of the...
- Has a diagnosis of primary or acquired immunodeficiency disorder or taking any other form of immunosuppressive therapy within 7 days prior the first dose of study drug.
- Has symptomatic ascites or pleural effusion, requires surgical intervention of additional medication
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- New York, New York, United States
- Philadelphia, Pennsylvania, United States
- Copenhagen, Denmark
- Herlev, Denmark
- Budapest, Hungary
- Debrecen, Hungary
- Omsk, Russia
- Saint Petersburg, Russia
- Barcelona, Spain
- Madrid, Spain
- Gothenburg, Sweden
- Lund, Sweden
- Stockholm, Sweden
- Birmingham, United Kingdom
- Leicester, United Kingdom
- London, United Kingdom
- Manchester, United Kingdom
- Southampton, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; New York, New York, United States; Philadelphia, Pennsylvania, United States; Copenhagen, Denmark; Herlev, Denmark; Budapest, Hungary and 13 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.