Advanced MalignanciesPhase 1/2NCT04752826
BI-1808 as a Single Agent and With Pembrolizumab (KEYTRUDA® ) in Treatment of Advanced Malignancies(Keynote-D20)
A Phase 1/2 study testing BI-1808, Pembrolizumab (KEYTRUDA® ) 25 Mg/mL Solution for Injection and Paclitaxel 80 mg/m2 weekly in people with Advanced Malignancies and Ovarian Cancer, run by BioInvent International AB at 25 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Malignancies, Ovarian Cancer, T-cell Lymphoma
- What is being tested?
- BI-1808, Pembrolizumab (KEYTRUDA® ) 25 Mg/mL Solution for Injection and Paclitaxel 80 mg/m2 weekly
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 25 sitesin 7 countries
- Study dates
- 25 Jan 2021to 31 Dec 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
25 sites in 7 countries. Contact the study team or a site near you to ask about taking part.
25 sites in 7 countries
United Kingdom7 sites, 7 recruiting
- Recruiting
University Hospital Birmingham
Birmingham
Julia Scarisbrick, Prof.
- Recruiting
University Hospitals of Leicester NHS Trust
Leicester, LE1 5WW
Harriet Walter
- Recruiting
Guy's and Saint Thomas' NHS Foundation Trust
London, SE1 9RT
Stephen Morris
- Recruiting
Sarah Cannon Research Institute UK
London, W1G 6AD
Anja Williams
- Recruiting
The Royal Marsden Hospital NHS Foundation Trust
London
Juanita Lopez
- Recruiting
The Christie NHS Foundation Trust
Manchester, M20 4BX
Richard Cowan
- Recruiting
Southampton General Hospital
Southampton, SO16 6YD
Sean Lim
Spain4 sites, 4 recruiting
- Not yet recruiting
Institut Catala d'oncologia. Hospital Duran I Reynals
Barcelona, 08907
- Not yet recruiting
Hospital Universitario Puerta de Hierro-Majadahonda, Madrid,
Madrid, 28007
- Recruiting
START Madrid - Hospital Universitario Fundación Jiménez Díaz
Madrid, 28040
- Recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
United States3 sites, 3 recruiting
- Recruiting
City of Hope National Medical Center
Duarte, California, 91010
Christiane Querfeld
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10021
Jasmine Zain
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Stefan Barta
Hungary3 sites, 1 recruiting
- Active, not recruiting
PRA Health Sciences - Hungary
Budapest, 1077
- Recruiting
Magyar Honvédség-Egészségügyi Központ
Budapest, 1134
Zsuzsanna Pápai
- Withdrawn
Debreceni Egyetem Klinikai Központ
Debrecen, 4032
Russia3 sites
- Terminated
Byudzhetnoye Uchrezhdeniye Zdravookhraneniya Omskoy Oblasti - Klinicheskiy Onkologicheskiy Dispanser
Omsk, 644013
- Withdrawn
National Medical Research Center VA Almazov
Saint Petersburg, 197022
- Withdrawn
N.N. Petrov National Medical Research Center of Oncology
Saint Petersburg, 197758
Sweden3 sites, 3 recruiting
- Recruiting
Sahlgrenska University Hospital
Gothenburg, 41345
Edvard Abel
- Recruiting
Skanes University Hospital
Lund, 223 70
Ana Carnerio
- Recruiting
Karolinska University Hospital, Solna
Stockholm, 17176
Jeffrey Yachnin
Denmark2 sites, 2 recruiting
- Recruiting
Rigshospitalet
Copenhagen
Kristoffer Staal Rohrberg
- Recruiting
Herlev Hospital
Herlev, 2730
Rikke Løvendahl Eefsen
About this study
Official title: 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
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:
Read more
- 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),
Read the 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, 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).
- Conditions
- Advanced Malignancies, Ovarian Cancer, T-cell Lymphoma, Melanoma
- Being tested
- BI-1808, Pembrolizumab (KEYTRUDA® ) 25 Mg/mL Solution for Injection, Paclitaxel 80 mg/m2 weekly
- Keywords
- Advanced Malignancies, T-cell Lymphoma
- Medical subject headings
- Ovarian Neoplasms, Lymphoma, T-Cell, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI-1808Drug
BI-1808 administered as a flat-dose IV infusion once every 3 weeks
Pembrolizumab (KEYTRUDA® ) 25 Mg/mL Solution for InjectionDrug
Pembrolizumab administered as a flat-dose IV infusion once every 3 weeks.
Paclitaxel 80 mg/m2 weeklyDrug
Paclitaxel administered as a flat-dose IV infusion weekly.
| Study group | Role | What they receive |
|---|---|---|
| Phase I, Part A - Dose escalation and safety of BI-1808 as single agent | Experimental | Dose escalation of BI-1808 administrated a single agent Receives: Drug: BI-1808 |
| Phase I, Part B - Dose escalation and Safety of BI-1808 in combination with pembrolizumab | Experimental | Dose escalation of BI-1808 in combination with pembrolizumab. Receives: Drug: BI-1808; Drug: Pembrolizumab (KEYTRUDA® ) 25 Mg/mL Solution for Injection |
| Phase 2a - Part A dose expansion of BI-1808 as a single agent | Experimental | BI-1808 administered as a single agent at the hypothesized recommended phase 2 dose determined in Phase 1 Receives: Drug: BI-1808 |
| Phase 2a, Part B - Dose expansion of BI-1808 in combination with pembrolizumab | Experimental | BI-1808 administered in combination with pembrolizumab at the respective hypothesized recommended phase 2 doses determined in Phase 1 Receives: Drug: BI-1808; Drug: Pembrolizumab (KEYTRUDA® ) 25 Mg/mL Solution for Injection |
| Phase 2a, Part C - Dose expansion of BI-1808 in combination with pembrolizumab and paclitaxel | Experimental | BI-1808 administered in combination with pembrolizumab and paclitaxel at the respective hypothesized recommended phase 2 doses determined in Phase 1. Receives: Drug: BI-1808; Drug: Pembrolizumab (KEYTRUDA® ) 25 Mg/mL Solution for Injection; Drug: Paclitaxel 80 mg/m2 weekly |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of adverse events (AEs)
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.
Measured: 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)
Determine the hypothesized RP2D dose for BI-1808 Phase 2a according to mTPI-2 design
Measured: Up to 104 weeks (2 years)
Occurrence of serious adverse events (SAEs)
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
Measured: Up to 104 weeks (2 years)
To identify the recommended Phase 2 dose (RP2D) of BI-1808,
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.
Measured: up to 104 weeks (2 years)
Secondary outcomes (3)
Evaluation of PK parameters for BI-1808. Maximum observed plasma concentration (Cmax)
Study the PK profile of BI-1808 according to a non-compartmental analysis using a validated software
Measured: Up to 104 weeks (2 years)
Evaluation of ADA response to BI-1808 in serum with validated method
The detection and characterization of antibodies to BI-1808 will be performed using a validated method and will be evaluated for BI-1808 serum concentration to enable interpretation of the antibody data
Measured: Up to 104 weeks (2 years)
Measurement of TNFR2 receptor occupancy on CD14+ and/CD16+ cells in serum with validated method
evaluate the receptor occupancy of BI-1808 as a single agent and in combination with pembrolizumab or pembrolizumab and paclitaxel on T-cells expressing TNFR2 in absolute value
Measured: Up to 104 weeks (2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2021
- Study start25 Jan 2021
- Primary completion31 Jan 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced MalignanciesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Phase 1/2a, dose escalation, consecutive-cohort, open-label study trial of BI-1808 as a Single Agent in Combination with Pembrolizumab and in combination with Pembrolizumab and Paclitaxel in Subjects with advanced malignancies.
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioInvent International AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Andres McAllister, PhD, Study director, BioInvent International AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04752826
- Sponsor's protocol ID
- 19-BI-1808-01
- Other IDs
- 2023-509847-29-00, MK3475-D20, 2023
- Status last verified
- Sep 2026
- First submitted
- 15 Dec 2020
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04752826
- Acronym / sponsor ID
- 19-BI-1808-01
- Conditions
- Advanced Malignancies, Ovarian Cancer, T-cell Lymphoma, Melanoma
- Keywords
- Advanced Malignancies, T-cell Lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- BioInvent International ABIndustry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 25 Jan 2021 (actual)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 12 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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),
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, 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- Phase 1/2a, dose escalation, consecutive-cohort, open-label study trial of BI-1808 as a Single Agent in Combination with Pembrolizumab and in combination with Pembrolizumab and Paclitaxel in Subjects with advanced malignancies.
| Arm | Type | Receives |
|---|---|---|
| Phase I, Part A - Dose escalation and safety of BI-1808 as single agent | Experimental | Drug: BI-1808Dose escalation of BI-1808 administrated a single agent |
| Phase I, Part B - Dose escalation and Safety of BI-1808 in combination with pembrolizumab | Experimental | Drug: BI-1808, Drug: Pembrolizumab (KEYTRUDA® ) 25 Mg/mL Solution for InjectionDose escalation of BI-1808 in combination with pembrolizumab. |
| Phase 2a - Part A dose expansion of BI-1808 as a single agent | Experimental | Drug: BI-1808BI-1808 administered as a single agent at the hypothesized recommended phase 2 dose determined in Phase 1 |
| Phase 2a, Part B - Dose expansion of BI-1808 in combination with pembrolizumab | Experimental | Drug: BI-1808, Drug: Pembrolizumab (KEYTRUDA® ) 25 Mg/mL Solution for InjectionBI-1808 administered in combination with pembrolizumab at the respective hypothesized recommended phase 2 doses determined in Phase 1 |
| Phase 2a, Part C - Dose expansion of BI-1808 in combination with pembrolizumab and paclitaxel | Experimental | Drug: BI-1808, Drug: Pembrolizumab (KEYTRUDA® ) 25 Mg/mL Solution for Injection, Drug: Paclitaxel 80 mg/m2 weeklyBI-1808 administered in combination with pembrolizumab and paclitaxel at the respective hypothesized recommended phase 2 doses determined in Phase 1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BI-1808BI-1808 administered as a flat-dose IV infusion once every 3 weeks | Drug | Phase 2a - Part A dose expansion of BI-1808 as a single agent, Phase 2a, Part B - Dose expansion of BI-1808 in combination with pembrolizumab, Phase 2a, Part C - Dose expansion of BI-1808 in combination with pembrolizumab and paclitaxel, Phase I, Part A - Dose escalation and safety of BI-1808 as single agent, Phase I, Part B - Dose escalation and Safety of BI-1808 in combination with pembrolizumab |
| Pembrolizumab (KEYTRUDA® ) 25 Mg/mL Solution for InjectionPembrolizumab administered as a flat-dose IV infusion once every 3 weeks. | Drug | Phase 2a, Part B - Dose expansion of BI-1808 in combination with pembrolizumab, Phase 2a, Part C - Dose expansion of BI-1808 in combination with pembrolizumab and paclitaxel, Phase I, Part B - Dose escalation and Safety of BI-1808 in combination with pembrolizumab |
| Paclitaxel 80 mg/m2 weeklyPaclitaxel administered as a flat-dose IV infusion weekly. | Drug | Phase 2a, Part C - Dose expansion of BI-1808 in combination with pembrolizumab and paclitaxel |
Primary outcome
Occurrence of adverse events (AEs)
Time frame: 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)
Time frame: 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)
Time frame: 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,
Time frame: 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.
3 secondary outcomes
Evaluation of PK parameters for BI-1808. Maximum observed plasma concentration (Cmax)
Time frame: Up to 104 weeks (2 years)
Evaluation of ADA response to BI-1808 in serum with validated method
Time frame: Up to 104 weeks (2 years)
Measurement of TNFR2 receptor occupancy on CD14+ and/CD16+ cells in serum with validated method
Time frame: Up to 104 weeks (2 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andres McAllister, PhD study director
BioInvent International AB
25 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BI-1808, Pembrolizumab (KEYTRUDA® ) 25 Mg/mL Solution for Injection and Paclitaxel 80 mg/m2 weekly in people with Advanced Malignancies and Ovarian Cancer, run by BioInvent International AB at 25 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United Kingdom, Spain, United States, Hungary, Russia and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Susanne Gertsson (+46462868550, susanne.gertsson@bioinvent.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.