A Phase I, Open-label, Single Arm Study to Evaluate the Safety, Tolerability, and Antitumor Activity of BRY805 in Participants With Advanced Solid Tumors

BioRay Pharmaceutical Co., Ltd.1 site in 1 country13 target enrollmentMarch 13, 2024

ConditionsAdvanced Solid Tumor

InterventionsBRY805 injection

DrugsBRY805 injection

Overview

Phase: Phase 1
Intervention: BRY805 injection
Conditions: Advanced Solid Tumor
Sponsor: BioRay Pharmaceutical Co., Ltd.
Enrollment: 13
Locations: 1
Primary Endpoint: Occurrence of Drug Limited Toxicities (DLTs)
Status: Terminated
Last Updated: 5 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a phase 1 open label multicenter study to evaluate safety, tolerance and the maximum tolerance of BRY805 administered intravenously (IV) once every three weeks in participants with advanced solid tumors, so as to confirm the recommended phase 2 dose of BRY805 and obtain the preliminary efficacy information of participants with advanced solid tumors.

Registry

clinicaltrials.gov

Start Date

March 13, 2024

End Date

July 4, 2025

Last Updated

5 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

BioRay Pharmaceutical Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•1\. Willing and able to provide signed informed and to comply with all study procedures;
•Male or female ≥ 18 years;
•Advanced malignant solid tumor patients who have experienced treatment failure using established therapeutic methods, have no viable standard treatment options available, or are unable to tolerate standard therapy;
•ECOG score ≤ 1;
•Life expectancy ≥ 3 months;
•Considering that the phase I trial mainly evaluates the safety and tolerability of the drug, subjects who cannot measure the lesion can be enrolled in the dose escalation phase to obtain more safety, pharmacokinetic and pharmacodynamic results. Enrolled subjects who may have been expanded at 1-3 doses that may have been selected in the early period, have at least one measurable lesion in the baseline period according to RECIST v1.1;
•Recovery, to Grade 0-1, from adverse events related to prior anticancer therapy except alopecia, \< Grade 2 sensory neuropathy and endocrinopathies controlled with hormone replacement therapy;
•Sufficient organ and bone marrow function;
•Female subjects of childbearing age must have a negative serum pregnancy test result when they enter this study (tested within 1 week before the first dose); Female subjects of childbearing potential or male subjects whose sexual partner is a female of childbearing age, who are willing to use appropriate and effective contraceptive measures such as abstinence and double barrier methods (such as condoms plus contraceptive diaphragms), oral contraceptives, intrauterine device insertion, etc., during the study period and within 6 months after the last dose.

Exclusion Criteria

•1\. Hypersensitivity to study drug or components of its formulation; or have had a severe allergic reaction to other monoclonal antibodies;
•Prior treatment with NKG2A-targeted agents;
•Participants will be excluded if they meet any of the following criteria:
•Major surgery within 4 weeks prior to the first dose, or anticipated major surgery during the study, minor surgery within 2 weeks prior to the first dose;
•Use of immunosuppressive medications within 2 weeks prior to the first dose; nasal and inhaled corticosteroids or physiologic doses of systemic steroids (i.e., no more than 10 mg/day of prednisone or equivalent pharmacophysiological doses of other corticosteroids) are allowed in the absence of active autoimmune disease;
•Live vaccine administration within 4 weeks prior to the first dose, at any time during the study, or within 1 month after the last dose; ④ Received anti-tumor therapy (including chemotherapy, radiotherapy, immunotherapy, endocrine therapy, targeted therapy, biological therapy, or tumor embolization) within 5 half-lives or 4 weeks (whichever is shorter) prior to the first dose, or used therapeutic radiopharmaceuticals (strontium, samarium, etc.) within 8 weeks prior to the first dose; ⑤ Participation in other clinical trials within 4 weeks prior to the first dose.
•4\. Active autoimmune disease or history of autoimmune disease that may recur, including but not limited to systemic lupus erythematosus, psoriasis, rheumatoid arthritis, inflammatory bowel disease, Hashimoto's thyroiditis, etc. Except for conditions that require only alternative therapy (e.g., residual hypothyroidism due to autoimmune thyroiditis);
•Symptomatic central nervous system metastases. Asymptomatic patients with CNS metastases who are radiographically and neurologically stable ≥for 4 weeks after CNS-directed therapy and are on stable or reduced doses of corticosteroids are eligible for study entry;
•History of any malignancy within the past 5 years, with the exception of cured cervical carcinoma in situbasal, basal cell or squamous epithelial cell carcinoma of the skin, localized prostate cancer, ductal carcinoma in situ of the breast, or other malignancies that have been previously treated and judged by the investigator to have stable disease status;
•Active HIV, hepatitis B or hepatitis C virus. A positive TP specific antibody test requires testing for syphilis non-specific antibodies;

Arms & Interventions

BRY805

Intervention: BRY805 injection

Outcomes

Primary Outcomes

Occurrence of Drug Limited Toxicities (DLTs)

Time Frame: From Time of First dose through DLT observation period, 21 days

To assess by the occurrence of Drug Limited Toxicities (DLTs)

Type and incidence of Treatment-emergent adverse event (TEAEs) and serious adverse events (SAEs)

Time Frame: From first dose until up to 91 days after the last dose

To assess by the occurrence of Treatment-emergent adverse event (TEAEs) and serious adverse events (SAEs)

Secondary Outcomes

BRY805 Serum Concentrations(From first dose to 31 days after the last dose)
Number of Participants with BRY805 Antibodies(From first dose to 31 days after the last dose)
Overall Response Rate (ORR)(Until study termination (approximately 2 years))
Disease Control Rate (DCR)(Until study termination (approximately 2 years)
Progression-Free Survival (PFS)(Until study termination (approximately 2 years))