A Study of BRY812 for Injection Alone in Subjects With Advanced Malignancies
ConditionAdvanced Malignancies
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorBioRay Pharmaceutical Co., Ltd.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
(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);
(3) In Phase Ia: patients must have advanced solid tumors confirmed by histopathology and/or cytology, who have failed to respond to standard-of-care (disease progression after treatment) or who could not tolerate standard-of-care, or who could not obtain effective standard-of-care or for whom there was no effective standard-of-care available; (Note: the patient population and inclusion criteria in phase Ib will be determined according to the data of phase Ia);
(4) According to RECIST v1.1 (Response Evaluation Criteria in Solid Tumors), there is at least 1 measurable lesion;
Disqualifiers
(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);
Trial design
Design model
Single group
Treatments tested in this trial
BRY812 for injection
DrugBRY812 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.
Treatment groups
164 Participants
are divided into 1 treatment groupGroup A: BRY812Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From Day 1 to 30 days after last dose; approximately 2 years2
Incidence of laboratory abnormalities
To be summarized using descriptive statistics
Time frame
From Day 1 to 30 days after last dose; approximately 2 year3
Maximum Tolerated Dose (MTD) of BRY812 for injection
Maximum Tolerated Dose (MTD) of BRY812 for injection
Time frame
From the first dose to the last dose；approximately 2 year4
Recommended phase II dose (RP2D) of BRY812 for injection
Recommended phase II dose (RP2D) of BRY812 for injection
Time frame
From the first dose to the last dose；approximately 2 yearSecondary outcomes
1
Objective response rate (ORR)
ORR is defined as the proportion of patients with complete response (CR) or partial response (PR) per RECIST v1.1.
Time frame
Through 1 month following last dose; approximately 2 years2
Progression-free survival (PFS)
PFS is defined as the time from start of study treatment to first documentation of tumor progression (clinical progression or PD per RECIST v1.1).
Time frame
Up to approximately 3 years3
Overall survival (OS)
OS is defined as the time from start of study treatment to date of death due to any cause
Time frame
Up to approximately 3 years4
Duration of response (DOR)
DOR is defined as the time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of tumor progression (clinical progression or progressive disease (PD) per RECIST v1.1)
Time frame
Up to approximately 3 yearsSponsors and contacts
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Source ClinicalTrials.gov