A Study of BI-1206 in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors (KEYNOTE-A04)

STATUS

Recruiting
participants needed

90
sponsor

BioInvent International AB

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Updated on 19 February 2024

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cancer

epidermal growth factor receptor

measurable disease

solid tumour

pembrolizumab

lung cancer

solid tumor

antineoplastic

monoclonal antibodies

growth factor

targeted therapy

lymphoma

ros1

advanced solid tumor

pd-l1

antibody therapy

metastatic melanoma

melanoma

non-small cell lung cancer

BRAF

small cell lung cancer

Summary

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

Description

This is a Phase 1/2a, multicenter, dose-finding, consecutive-cohort, open-label trial of BI-1206 in combination with pembrolizumab in subjects with advanced solid tumors who have previously received treatment with a PD-1/PD-L1 immune checkpoint inhibitor.

The trial will consist of 2 main parts: Phase 1 (with dose escalation cohorts and selection of the RP2D), and Phase 2a (with 3 expansion cohorts at the RP2D).

Subjects in each phase will initially receive 3 planned doses of therapy with BI-1206 in combination with pembrolizumab.

Subjects who show clinical benefit (CR, PR or SD) at the Week 9 Visit may continue on combination therapy. Starting at Week 10, these subjects will receive infusions every 3 weeks for up to 32 additional doses or up to 2 years from first dose of BI-1206 therapy or until progression.

Details

Condition	Solid Tumor, Adult
Age	18years - 100years
Treatment	Pembrolizumab 25 MG/ML(MK-3475)
Clinical Study Identifier	NCT04219254
Sponsor	BioInvent International AB
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Is willing and able to provide written informed consent for the trial
	Is 18 years of age on 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/L1 mAb, and have documented progression on or within 12 weeks from the last dose of anti-PD-1/L1 mAb
	Is intolerant of, refuses, or is not eligible for standard antineoplastic therapy
	Has at least 1 measurable disease lesion as defined by Response Evaluation Criteria in Solid Tumors
	Is able to safely undergo a baseline tumor tissue biopsy prior to first dose of BI-1206
	Has a life expectancy of 12 weeks
	Has an 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
	Cohort 1 (Non-small cell lung cancer)
	For subjects whose tumor has PD-L1 50%: Required prior therapies will include anti-PD-1 therapy as monotherapy. Prior standard of care chemotherapy will be allowed but not required
	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
	For subjects with known anaplastic lymphoma kinase, ROS1 or epidermal growth factor receptor sensitizing molecular rearrangements, one line of targeted therapy will be required in addition to anti-PD-1/PD-L1 therapy
	Cohort 2 (Metastatic Melanoma)
	Required prior therapies will include anti-PD-1 therapy either as monotherapy or as part of a combination regimen
	For subjects with a known BRAF V600-activating mutation combination targeted therapy will be required in addition to anti-PD-1/PD-L1 therapy
	Cohort 3 (Other Tumor Types)
	All subjects will require prior anti-PD-1/PD-L1 therapy
Exclusion Criteria
	Needs doses of prednisolone >10 mg daily (or equipotent doses of other corticosteroids)
	Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
	Has known or suspected hypersensitivity to pembrolizumab or BI-1206 or any of their excipients
	Has cardiac or renal amyloid light-chain (AL) amyloidosis
	Has received the following
	Chemotherapy or small molecule products within 4 weeks of first dose of BI 1206
	Radiotherapy within 2 weeks of first dose of BI-1206. 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
	Immunotherapy within 4 weeks prior to the first dose of BI-1206
	Has not recovered from AEs to at least Grade 1 by Common Terminology Criteria for Adverse Events v4.0 due to prior anti-cancer therapies
	Has had Grade 3 autoimmune manifestations of previous immune checkpoint inhibitor treatments
	Has a history of (non-infectious) 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). o Intravaginal
	Is a male subject with partner(s) of child-bearing potential 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 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 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 is not in the best interest of the subject to participate, in the opinion of the treating 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 first dose of study drug. Subjects who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent. Participation in an observational trial is acceptable
	Has a known additional malignancy of another type
	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

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A Study of BI-1206 in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors (KEYNOTE-A04)