Trial Title:
BI-1910 as a Single Agent and in Combination With Pembrolizumab for the Treatment of Advanced Solid Tumors
NCT ID:
NCT06205706
Condition:
Solid Tumors
Non Small Cell Lung Cancer
Hepatocellular Carcinoma
Conditions: Official terms:
Carcinoma, Hepatocellular
Pembrolizumab
Conditions: Keywords:
solid tumors
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Intervention model description:
This is a Phase 1/2a, open-label, dose-escalation, multicenter, FIH, consecutive-cohort,
clinical trial of BI-1910, as a single agent and in combination with pembrolizumab.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
BI-1910
Description:
BI-1910 administered as a flat-dose IV infusion once every 3 weeks
Arm group label:
Phase 2a, Part A - Dose expansion of BI-1910 as single agent
Arm group label:
Phase 2a, Part B - Dose expansion of BI-1910
Arm group label:
Phase I, Part A - Dose escalation and safety of BI-1910 as single agent
Arm group label:
Phase I, Part B - Dose escalation and safety of BI-1910 in combination with pembrolizumab
Intervention type:
Drug
Intervention name:
Pembrolizumab
Description:
Pembrolizumab be administered as an IV infusion at its standard flat dose (200 mg) once
every 3 weeks prior to the BI-1910 infusion
Arm group label:
Phase 2a, Part B - Dose expansion of BI-1910
Arm group label:
Phase I, Part B - Dose escalation and safety of BI-1910 in combination with pembrolizumab
Summary:
The goal of this first in human clinical trial is to test BI-1910 administered as single
agent and in combination with pembrolizumab in subjects with advanced/metastatic solid
tumors whose disease has progressed after standard therapy.
The main questions it aims to answer are:
- how safe and tolerable is BI-1910
- what is maximum tolerated or administrated dose
- to determine recommended dose for further clinical trials
Participants will receive infusions of BI-1910 alone or combination with pembrolizumab
every 3 weeks.
Detailed description:
This is a Phase 1/2a, open-label, dose-escalation, multicenter, FIH, consecutive-cohort,
clinical trial of BI-1910, as a single agent and in combination with pembrolizumab, in
subjects with advanced/metastatic solid tumors whose disease has progressed after
standard therapy.
The trial comprises 2 phases: a Phase 1 with Parts A and B, and a Phase 2a with Parts A
and B.
Phase 1 Part A consists of a dose escalation of BI-1910 as a single agent to evaluate
safety and tolerability and to determine the RP2D as a single agent (sRP2D) in subjects
with advanced/metastatic solid tumors whose disease has progressed after standard
therapy.
Phase 1 Part B consists of a dose escalation of BI-1910 in combination with pembrolizumab
to evaluate the safety and tolerability of the combination treatment and to allow
selection of the RP2D for BI-1910 in combination with pembrolizumab (cRP2D) in subjects
with advanced/metastatic solid tumors whose disease has progressed after standard
therapy.
Phase 2a will assess BI-1910 administered as a single agent (Part A) and in combination
with pembrolizumab (Part B) at the respective hypothesized RP2D(s) determined in Phase 1.
Phase 2a expansion will be conducted in indication specific cohorts of subjects. The aim
of the Phase 2a is to urther assess the safety and tolerability of BI-1910 as a single
agent (Part A) and in combination with pembrolizumab (Part B), characterize its PK and
pharmacodynamics, and assess preliminary antitumor activity by ORR, DoR, and
progression-free survival (PFS), as measured by RECIST v1.1 and iRECIST.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Is willing and able to provide signed informed consent for the trial.
2. Is ≥18 years of age on the day of signing the informed consent form.
3. Has a histologically-confirmed advanced/metastatic solid tumor.
4. Has received standard of care and progressed or is intolerant of, or is not eligible
to receive standard of care antineoplastic therapy.
5. Has at least 1 measurable disease lesion as defined by RECIST v1.1.
6. Must be willing to provide tumor biopsies as specified in the schedule of
assessments
7. Has a life expectancy of ≥12 weeks.
8. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
9. Has adequate organ function as confirmed by laboratory values.
Exclusion Criteria:
1. Needs doses of prednisolone >10 mg daily (or equipotent doses of other
corticosteroids) while on the trial other than as premedication.
2. Has known active central nervous system (CNS) metastases and/or carcinomatous
meningitis.
3. Has known or suspected hypersensitivity to BI-1910 or pembrolizumab.
4. Has cardiac or renal amyloid light-chain amyloidosis.
5. Has received the following:
1. Chemotherapy or small molecule anti-cancer therapy products within 4 weeks, or
5 half-lives of the respective drug whichever is longer, of first dose of
BI-1910.
2. Radiotherapy within 2 weeks of first dose of BI-1910. A 1-week washout is
permitted for palliative radiation (≤2 weeks of radiotherapy) for non-CNS
disease.
Subjects who have previously had radiation pneumonitis are not allowed.
3. Immunotherapy within 4 weeks prior to the first dose of BI-1910.
6. Has not recovered from AEs to at least Grade 1 by National Cancer Institute (NCI)
Common Terminology Criteria for Adverse Events (CTCAE) (v5.0 or higher).
7. Has had Grade ≥3 autoimmune manifestations of previous immune checkpoint inhibitor
treatments (e.g., anti-PD-1, anti-PD-L1, or anti-CTLA-4).
8. Has a history of (noninfectious) pneumonitis that required steroids or has current
pneumonitis.
9. Has an active, known, or suspected autoimmune disease.
10. Is a female subject and has the ability to become pregnant (or already pregnant or
lactating/breastfeeding). However, those female subjects who have a negative serum
or urine pregnancy test up to 72 hours prior to their first dose of study treatment
and agree to use a highly effective method of birth control for 4 weeks before
entering the trial, during the trial, and for 12 months after their last dose of
study treatment are considered eligible.
11. Is a male subject with partner(s) of childbearing potential (unless he agrees to use
a barrier method of contraception [condom plus spermicidal gel] with the female
partner(s) who are using one highly effective method of contraception during the
trial and for 12 months after completing treatment).
12. Has had major surgery from which the subject has not yet recovered.
13. Is at high medical risk because of nonmalignant systemic disease including severe
active infections on treatment with antibiotics, antifungals, or antivirals other
than the ones considered adequate for treatment of HBV.
14. Has presence of chronic graft versus host disease.
15. Has had an allogenic tissue/solid organ transplant.
16. Is positive for Human Immunodeficiency Virus (HIV).
17. Has history of chronic HBV or HCV infections.
18. Has a history of active tuberculosis (Bacillus tuberculosis).
19. Has received a live vaccine within 30 days before the first dose of study treatment.
20. Has uncontrolled or significant cardiovascular disease.
21. Has a known psychiatric or substance abuse disorder that would interfere with the
subject's ability to cooperate with the requirements of the trial.
22. 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 not in the best
interest of the subject to participate, in the opinion of the treating Investigator.
23. Is participating or planning to participate in another interventional 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 study treatment.
24. Has a known additional malignancy of another type, with the exception of adequately
treated cone-biopsied carcinoma in situ and basal or squamous cell carcinoma of the
skin. Male subjects with asymptomatic prostate cancer without known metastatic
disease and with no requirement for therapy or requiring only hormonal therapy and
with normal prostate-specific antigen for >1 year prior to start of study treatment
are eligible.
25. Has a confirmed diagnosis of primary immunodeficiency or an acquired condition that
leads to an immunodeficiency disorder or taking any other form of immunosuppressive
therapy within 7 days prior the first dose of study treatment.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Yale Cancer Center
Address:
City:
New Haven
Zip:
06519
Country:
United States
Status:
Recruiting
Investigator:
Last name:
So Yeon Kim, MD
Email:
Principal Investigator
Facility:
Name:
Rigshospitalet
Address:
City:
Copenhagen
Country:
Denmark
Status:
Recruiting
Investigator:
Last name:
Kristoffer Staal Rohrberg, PhD
Email:
Principal Investigator
Facility:
Name:
Charité Universitätsmedizin Berlin
Address:
City:
Berlin
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Sebastian Ochsenreither
Investigator:
Last name:
Sebastian Ochsenreither, Prof
Email:
Principal Investigator
Facility:
Name:
Universitätsklinikum Essen
Address:
City:
Essen
Country:
Germany
Status:
Not yet recruiting
Contact:
Last name:
Isabel Virchow
Investigator:
Last name:
Isabel Virchow, MD
Email:
Principal Investigator
Facility:
Name:
Uniwersytecki Szpital Kliniczny
Address:
City:
Poznań
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Rodryg Ramlau, Prof
Facility:
Name:
Instytut Centrum Zdrowia Matki Polki
Address:
City:
Łódź
Country:
Poland
Status:
Recruiting
Investigator:
Last name:
Ewa Kalinka, Prof
Email:
Principal Investigator
Facility:
Name:
Hospital HM Nou Delfos
Address:
City:
Barcelona
Zip:
08023
Country:
Spain
Status:
Recruiting
Investigator:
Last name:
Tatiana Hernandez Guerrero, MD
Email:
Principal Investigator
Facility:
Name:
HM Sanchinarro
Address:
City:
Madrid
Country:
Spain
Status:
Recruiting
Investigator:
Last name:
Irene Moreno Candilejo, PhD
Email:
Principal Investigator
Facility:
Name:
Hospital Fundacion Jimenez Diaz
Address:
City:
Madrid
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Bernard Doger de Speville, PhD
Facility:
Name:
Hospital universitario Virgen del Rocio
Address:
City:
Sevilla
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Alejandro Falcon Gonzalez, PhD
Facility:
Name:
Lund University Hospital
Address:
City:
Lund
Country:
Sweden
Status:
Not yet recruiting
Investigator:
Last name:
Ana Carneiro, PhD
Email:
Principal Investigator
Facility:
Name:
Karolinska University Hospital, Solna
Address:
City:
Stockholm
Country:
Sweden
Status:
Recruiting
Investigator:
Last name:
Yachnin, PhD
Email:
Principal Investigator
Start date:
December 4, 2023
Completion date:
November 7, 2028
Lead sponsor:
Agency:
BioInvent International AB
Agency class:
Industry
Collaborator:
Agency:
Merck Sharp & Dohme LLC
Agency class:
Industry
Source:
BioInvent International AB
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06205706
