Recruiting NCT07346846
A Study of BGM-2121 in Patients With Advanced Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: BGM-2121.
- Who it may be relevant to
- Registry conditions: Advanced Solid Tumors. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Phase 1 First-in-human Study of BGM-2121 in Patients With Advanced Solid Tumors
Overview
This study is to explore the safety, tolerability, pharmacokinetics, and preliminary efficacy of BGM-2121 in adult patients with advanced solid tumors.
Interventions
- Drug BGM-2121
BGM-2121 treatment
Primary outcome measures
- Incidence of Dose-Limiting Toxicities (DLTs) [Time frame: From first dose through the DLT evaluation period (28 days)]
- Treatment Discontinuation Due to Drug-Related Adverse Events [Time frame: From first dose through study completion, an average of 1 year]
- Incidence of Treatment-Emergent and Treatment-Related Adverse Events [Time frame: From first dose through 6 weeks after the last dose of study treatment]
- Number of Participants With Grade ≥3 Laboratory Abnormalities [Time frame: From first dose through study completion, an average of 1 year]
- Changes in Electrocardiogram (ECG) Parameters [Time frame: From baseline through study completion, an average of 1 year]
Secondary outcome measures (6)
- Determination of Maximum Tolerated Dose (MTD) to establish RP2D [Time frame: From first dose through the DLT evaluation period (28 days)]
- Incidence of Anti-Drug Antibodies (ADAs) [Time frame: From first dose through 6 weeks after the last dose of study treatment]
- Peak Serum Concentration (Cmax) of BGM-2121 [Time frame: From first dose through 30 days after the last dose]
- Area under Curve (AUC) of BGM-2121 [Time frame: From first dose through 30 days after the last dose]
- Objective Response Rate (ORR) [Time frame: From baseline through study completion, an average of 1 year]
- Progression-Free Survival (PFS) [Time frame: 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]
Eligibility criteria
Inclusion criteria
- With either gender aged ≥ 18 years,
- Has a confirmed diagnosis of advanced solid tumor(s),
- The subject has received and failed standard-of-care anti-cancer therapy
- Has at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST)
- ...
Exclusion criteria
- Has any ongoing toxicity from previous anti-cancer treatments
- Has signs or symptoms of end-stage organ failure, major chronic illnesses other than cancer(s)
- History of another primary malignancy within the last three years
- ...
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Taiwan · 3 centers
- National Cheng Kung University Hospital — Tainan
- National Taiwan University Hospital — Taipei
- Taipei Veterans General Hospital — Taipei
Identifiers
NCT: NCT07346846 · BGM-2121-001