A Study of BRY812 for Injection Alone in Subjects With Advanced Malignancies

NCT06038058 | Recruiting Phase 1

• 1 other identifier: BRY812-ST-01
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase I, multicenter, open-label, single-arm and first-in-human clinical study of BRY812 for injection. The study objectives are to evaluate the safety, tolerability, pharmacokinetic profile, anti-tumor activity and immunogenicity of BRY812 for injection in patients with advanced malignancies. Patients will receive treatment every 3 weeks until intolerable toxicity, disease progression, pregnancy, withdrawal of informed consent, death, study discontinuation, or withdrawal from the study.

Conditions

Advanced Malignancies

Outcome Measures

Primary Outcomes (5)

• Incidence of adverse events

  An AE is any untoward medical occurrence in a patient or clinical investigational subjct administered a medicinal product and which does not necessarily have a causal relationship with this treatment.

  From Day 1 to 30 days after last dose; approximately 2 years

• Incidence of laboratory abnormalities

  To be summarized using descriptive statistics

  From Day 1 to 30 days after last dose; approximately 2 year

• Maximum Tolerated Dose (MTD) of BRY812 for injection

  Maximum Tolerated Dose (MTD) of BRY812 for injection

  From the first dose to the last dose；approximately 2 year

• Recommended phase II dose (RP2D) of BRY812 for injection

  Recommended phase II dose (RP2D) of BRY812 for injection

  From the first dose to the last dose；approximately 2 year

• Incidence of dose-limiting toxicity (DLT)

  Incidence of dose-limiting toxicity (DLT)

  Through 21 days after first dose

Secondary Outcomes (6)

• Objective response rate (ORR)

  Through 1 month following last dose; approximately 2 years

• Progression-free survival (PFS)

  Up to approximately 3 years

• Overall survival (OS)

  Up to approximately 3 years

• Duration of response (DOR)

  Up to approximately 3 years

• Pharmacokinetic assessment

  Through 18 weeks after dosing

Study Arms (1)

BRY812

EXPERIMENTAL

Drug: BRY812 for injection

Interventions

BRY812 for injection DRUG

BRY812 for injection will be administered by intravenous drip, tentatively once per cycle spanning 3 weeks on D1 of each cycle until intolerable toxicity, disease progression, pregnancy, withdrawal of informed consent, death, study discontinuation or withdrawal from the study. The dose of each administration will be calculated based on the weight measured prior to such administration. The dosing regimen (dosing frequency and interval) for subsequent study may be adjusted based on prior data. The intravenous drip should last for ≥ 90 min for the first dose and may be adjusted to ≥ 30 min for subsequent doses if the first dose is tolerable.

BRY812

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (1) Subjects who voluntarily sign the informed consent form, understand the nature, objectives, and procedure of the study and are able to complete the study according to the protocol;
• (2) Male or female patients, ≥ 18 years of age (based on the date of signing the informed consent form);
• (4) According to RECIST v1.1 (Response Evaluation Criteria in Solid Tumors), there is at least 1 measurable lesion;
• (5) Eastern Cooperative Oncology Group (ECOG) Status 0 to 1;
• (6) Adequate organ and bone marrow function (no treatment with cells, growth factors, or transfusions within 14 days prior to the first administration), as defined below:
• Hematology: absolute neutrophil count (ANC) ≥ 1.5 × 109/L, platelet count (PLT) ≥ 100 × 109/L, hemoglobin (HGB) ≥ 90 g/L;
• Liver function: serum total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN) (except for subjects with Gilbert syndrome, TBIL ≤ 2 × ULN in patients with liver cancer or liver metastases), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN (in patients with liver cancer or liver metastases, ALT or AST ≤ 5 × ULN);
• Renal function: creatinine (Cr) ≤ 1.5 × ULN or creatinine clearance (CrCL) (based on Cockcroft-Gault equation) ≥ 60 mL/min;
• (7) Expected survival ≥ 12 weeks;
• (8) Female subjects with fertility potential must test negative for serum human chorionic gonadotropin (HCG) before they are enrolled in the study. Female subjects with fertility potential or male subjects who have a female partner must agree to maintain no pregnancy plan and take effective contraceptive measures such as condoms from the signing of ICF to 6 months after the last dose of study drug (see Annex 1 for details); females are considered fertile from menarche to menopause (at least 12 months without menstruation) unless they are permanently infertile (through hysterectomy, bilateral salpingectomy, or bilateral oophorectomy).

You may not qualify if:

• (1) Subjects who have previous severe hypersensitivity to BRY812 or known hypersensitivity to any component or excipient of the study drug;
• (2) Subjects who have previously received drugs which target LIV-1;
• (3) Subjects who have any active infection requiring systemic therapy by intravenous infusion within 2 weeks prior to the first dose of study drug;
• (4) Subjects who have previous or current presence of two or more primary tumors (excluding cured cervical carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma of the skin, and other tumors that have been stable for more than 5 years after treatment);
• (5) Subjects who have symptoms of active central nervous system metastases, except those with brain parenchymal metastases assessed as stable by the investigator based on the following conditions:
• No seizures within \> 12 consecutive weeks with or without the treatment of antiepileptic drugs;
• Glucocorticoids are not required;
• Two consecutive MRI scans (at least 4 weeks apart) show a stable state on imaging;
• Asymptomatic inactive brain metastases are newly identified where two consecutive MRI scans (at least 4 weeks apart) show a stable state on imaging;
• The conditions remain stable and asymptomatic for more than 1 month after treatment;
• (6) Subjects with serious cardiovascular and cerebrovascular diseases and lung diseases, including but not limited to:
• Stroke, intracranial hemorrhage, unstable angina pectoris, congestive heart failure (NYHA class III-IV), myocardial infarction, severe arrhythmias (such as sustained ventricular tachycardia and ventricular fibrillation), congenital long QT syndrome, torsade de pointes, and symptomatic pulmonary embolism within 6 months before enrollment;
• Uncontrolled hypertension (at least 2 consecutive measurements of systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg);
• Echocardiogram (ECHO) or multigated acquisition scan (MUGA) shows left ventricular ejection fraction (LVEF) \< 50%;
• During the screening period, the mean corrected (by Fridercia's formula) QT interval on three consecutive electrocardiograms is prolonged (\> 450 ms in males and \> 470 ms in females);

Sponsors & Collaborators

• BioRay Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Sun Yat-sen Memorial Hospital，Sun Yat-sen University

Guangzhou, Guangdong, 510120, China

RECRUITING

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

He rui Yao, PhD

CONTACT

(+86)13500018020; yaoherui@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2023
• First Posted: September 14, 2023
• Study Start: October 10, 2023
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: December 30, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)