Advanced Solid Tumors
Conditions
Brief summary
This study is to explore the safety, tolerability, pharmacokinetics, and preliminary efficacy of BGM-2121 in adult patients with advanced solid tumors.
Interventions
DRUGBGM-2121
BGM-2121 treatment
Sponsors
BioGate Precision Medicine Corp.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. With either gender aged ≥ 18 years, 2. Has a confirmed diagnosis of advanced solid tumor(s), 3. The subject has received and failed standard-of-care anti-cancer therapy 4. Has at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) 5. ...
Exclusion criteria
1. Has any ongoing toxicity from previous anti-cancer treatments 2. Has signs or symptoms of end-stage organ failure, major chronic illnesses other than cancer(s) 3. History of another primary malignancy within the last three years 4. ...
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Dose-Limiting Toxicities (DLTs) | From first dose through the DLT evaluation period (28 days) | Number and type of DLTs observed following administration of BGM-2121 at different dose levels, assessed according to protocol-defined criteria. |
| Treatment Discontinuation Due to Drug-Related Adverse Events | From first dose through study completion, an average of 1 year | Number of participants who permanently discontinue BGM-2121 due to drug-related adverse events, graded per CTCAE v5.0. |
| Incidence of Treatment-Emergent and Treatment-Related Adverse Events | From first dose through 6 weeks after the last dose of study treatment | Incidence, type, and timing of treatment-emergent adverse events (TEAEs), treatment-related adverse events (TRAEs), and serious adverse events (SAEs), graded per CTCAE v5.0. |
| Number of Participants With Grade ≥3 Laboratory Abnormalities | From first dose through study completion, an average of 1 year | Number of participants experiencing Grade 3 or higher laboratory abnormalities, including hematology and serum chemistry parameters, based on CTCAE v5.0 criteria |
| Changes in Electrocardiogram (ECG) Parameters | From baseline through study completion, an average of 1 year | Change from baseline in ECG parameters, including QT/QTc interval, PR interval, and QRS duration. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Determination of Maximum Tolerated Dose (MTD) to establish RP2D | From first dose through the DLT evaluation period (28 days) | MTD of BGM-2121 in subjects with advanced solid tumors, used to determine the recommended Phase 2 dose (RP2D). |
| Incidence of Anti-Drug Antibodies (ADAs) | From first dose through 6 weeks after the last dose of study treatment | Percentage of subjects who develop treatment-emergent ADAs during the study. |
| Peak Serum Concentration (Cmax) of BGM-2121 | From first dose through 30 days after the last dose | Cmax derived from serum concentration data. |
| Area under Curve (AUC) of BGM-2121 | From first dose through 30 days after the last dose | AUC derived from serum concentration data. |
| Objective Response Rate (ORR) | From baseline through study completion, an average of 1 year | Percentage of subjects with complete or partial response according to RECIST 1.1 criteria. |
| Progression-Free Survival (PFS) | From first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 80 weeks | Time from first treatment to documented disease progression or death. |
Countries
Taiwan
Contacts
CONTACTQueena Hwang
Outcome results
None listed