Phase 1/2a Clinical Trial of BI-1206, a Monoclonal Antibody to CD32b (Fc?RIIB), in Combination with Pembrolizumab in Subjects with Advanced Solid Tumors Previously Treated with Anti-PD-1 or AntiPD-L1 Antibodies - 18-BI-1206-03

BioInvent International AB0 sites105 target enrollmentFebruary 19, 2024

ConditionsAdvanced Solid Tumors MedDRA version: 21.1Level: LLTClassification code: 10065147Term: Malignant solid tumor Class: 10029104 Therapeutic area: Diseases [C] - Neoplasms [C04]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Advanced Solid Tumors
Sponsor: BioInvent International AB
Enrollment: 105
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

February 19, 2024

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

BioInvent International AB

Eligibility Criteria

Inclusion Criteria

•Is willing and able to provide written informed consent for the trial., Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0–1\., Has adequate organ function as confirmed by laboratory values listed in the main body of the protocol., Expansion Cohort\-specific Inclusion Criteria: In addition to the general inclusion criteria above, subjects must also meet the criteria for the specific cohort. Additional requirements will be added based on learnings from subjects enrolled in the Phase 1 part of the trial. 3\. Cohort 3 (Other Tumor Types): a. All subjects will require prior anti\-PD\-1/PD\-L1 therapy., Expansion Cohort\-specific Inclusion Criteria: In addition to the general inclusion criteria above, subjects must also meet the criteria for the specific cohort. Additional requirements will be added based on learnings from subjects enrolled in the Phase 1 part of the trial.1\. Cohort 1 (Non\-small\- cell lung carcinoma): a.For subjects whose tumor has PD\-L1 \=50%: Required prior therapies will include anti\-PD\-1 therapy as monotherapy. Prior standard of care (SOC) chemotherapy will be allowed but not required. b. For tumors with unknown PD\-L1 or PD\-L1 \<50% , required prior therapies will include anti\-PD 1/PD\-L1 therapy and SOC chemotherapy either combined with anti PD\-1/PD\-L1 therapy or given separately. c. For subjects with known anaplastic lymphoma kinase (ALK), ROS proto\- oncogene 1, receptor tyrosine kinase (ROS1\) or epidermal growth factor receptor (EGFR) sensitizing molecular rearrangements, or with BRAF mutations, at least 1 line of targeted therapy will be required in addition to anti\-PD\-1/PD\-L1 therapy., Expansion Cohort\-specific Inclusion Criteria: In addition to the general inclusion criteria above, subjects must also meet the criteria for the specific cohort. Additional requirements will be added based on learnings from subjects enrolled in the Phase 1 part of the trial. 2\. Cohort 2 (Metastatic Melanoma): a. Treatment\-naive subjects. b. For subjects with a known BRAF V600\-activating mutation, prior treatment should have included a targeted therapy in addition to anti\-PD1/PD\-L1 therapy., Is at \= 18 years of age on the day of signing informed consent., Has a histologically confirmed advanced solid tumor. Subjects must have received at least 2 doses of an approved anti\-PD\-1/PD\-L1 monoclonal antibody (mAb) administered either as monotherapy, or in combination with other checkpoint inhibitors or other therapies, and must have documented progression on or within 12 weeks from the last dose of anti\-PD\-1/PD\-L1 mAb., Has received standard of care or is intolerant of, refuses, or is not eligible for standard of care antineoplastic therapy., Has at least 1 measurable disease lesion as defined by the Response Evaluation Criteria in Solid Tumors (RECIST)., Is willing to safely undergo tissue biopsies of the involved tissue, if required. However, if the Investigator considers that a tissue biopsy is not safe and/or not technically feasible, then the subject will not be required to undergo the biopsy. a. The Screening biopsy must be performed prior to the first dose of BI\-1206 (on non\-previously irradiated lesions only), and at least 4 weeks after the last dose of tumor\-directed therapy. The biopsy at Screening can be replaced with a formalin\- fixed archival tumor tissue sample collected from a previous standard of care biopsy, provided that the biopsy was performed after the subject's last tumor\- directed therapy and prior to study

Exclusion Criteria

•Needs doses of prednisolone \>10 mg daily (or equipotent doses of other corticosteroids) while on the trial other than as premedication. During the Screening period, doses of up to 20 mg/day may be given but the dose must be reduced to 10 mg/day within 7 days prior to the first dose of study drug. Steroids are allowed as premedication in subjects with allergies to contrast scans., Is a female subject and has the ability to become pregnant (or already pregnant or lactating/ breastfeeding). Those female subjects who have a negative serum or urine pregnancy test before enrollment 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 the last dose of BI\-1206 are considered eligible. Highly effective methods of birth control are defined in protocol., Male subjects with partner(s) of childbearing potential are excluded unless the male partner 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 study and for 12 months after completing treatment., Has had major surgery from which the subject has not yet recovered., Is at high medical risk because of non\-malignant 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 virus (HIV) and/or history of hepatitis B or C infections, or has a positive test for HIV Ab, hepatitis B antigen/hepatitis B virus DNA or hepatitis C Ab or RNA., Has a history of active tuberculosis (bac. tuberculosis)., Has received a live vaccine within 30 days before the first dose of study treatment. COVID\-19 vaccines based on viral RNA or protein fragments, or killed viruses, are allowed. COVID 19 vaccines based on live replicating viral or bacterial vectors are not allowed., Has uncontrolled or significant cardiovascular disease as per protocol definition., Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated CNS metastases may participate provided they are radiologically stable (without evidence of progression for at least 4 weeks by repeat imaging \[performed during Screening]); have no newly\-onset or worsening symptomatology of brain metastases; and have not required steroids for at least 14 days before study treatment., Has a known psychiatric or substance abuse disorder that would interfere with the subject's ability to cooperate with the requirements of the study., Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or lead to participation not being in the best interest of the subject, in the opinion of the Investigator., 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 the first dose of study drug., Has known or suspected hypersensitivity to pembrolizumab or BI1206 or any of their excipients. Previous isolated IRRs are not to be considered a reason for exclusion unless Grade 4 in intensity., Has cardiac or renal amyloid light\-chain amyloidosis