Advanced Solid TumorsPhase 1NCT07346846
A Study of BGM-2121 in Patients With Advanced Solid Tumors
A Phase 1 study testing BGM-2121 in people with Advanced Solid Tumors, run by BioGate Precision Medicine Corp. at 3 sites in Taiwan.
Trial summary
This study is to explore the safety, tolerability, pharmacokinetics, and preliminary efficacy of BGM-2121 in adult patients with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- BGM-2121
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 3 sitesTaiwan
- Study dates
- 10 Mar 2026to Dec 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
- ...
Who cannot join
- 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
- ...
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan3 sites, 3 recruiting
- Not yet recruiting
National Cheng Kung University Hospital
Tainan
Queena Hwang, 886-2-2517-6512, clinical@biogate.com.tw
- Not yet recruiting
National Taiwan University Hospital
Taipei
Queena Hwang, 886-2-2517-6512, clinical@biogate.com.tw
- Recruiting
Taipei Veterans General Hospital
Taipei
Queena Hwang, 886-2-2517-6512 ext. 8556, clinical@biogate.com.tw
About this study
Official title: A Phase 1 First-in-human Study of BGM-2121 in Patients With Advanced Solid Tumors
This study is to explore the safety, tolerability, pharmacokinetics, and preliminary efficacy of BGM-2121 in adult patients with advanced solid tumors.
- Conditions
- Advanced Solid Tumors
- Being tested
- BGM-2121
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BGM-2121Drug
BGM-2121 treatment
| Study group | Role | What they receive |
|---|---|---|
| BGM-2121 | Experimental | Not described Receives: Drug: BGM-2121 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Dose-Limiting Toxicities (DLTs)
Number and type of DLTs observed following administration of BGM-2121 at different dose levels, assessed according to protocol-defined criteria.
Measured: From first dose through the DLT evaluation period (28 days)
Treatment Discontinuation Due to Drug-Related Adverse Events
Number of participants who permanently discontinue BGM-2121 due to drug-related adverse events, graded per CTCAE v5.0.
Measured: From first dose through study completion, an average of 1 year
Incidence of Treatment-Emergent and Treatment-Related Adverse Events
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.
Measured: From first dose through 6 weeks after the last dose of study treatment
Number of Participants With Grade ≥3 Laboratory Abnormalities
Number of participants experiencing Grade 3 or higher laboratory abnormalities, including hematology and serum chemistry parameters, based on CTCAE v5.0 criteria
Measured: From first dose through study completion, an average of 1 year
Changes in Electrocardiogram (ECG) Parameters
Change from baseline in ECG parameters, including QT/QTc interval, PR interval, and QRS duration.
Measured: From baseline through study completion, an average of 1 year
Secondary outcomes (6)
Determination of Maximum Tolerated Dose (MTD) to establish RP2D
MTD of BGM-2121 in subjects with advanced solid tumors, used to determine the recommended Phase 2 dose (RP2D).
Measured: From first dose through the DLT evaluation period (28 days)
Incidence of Anti-Drug Antibodies (ADAs)
Percentage of subjects who develop treatment-emergent ADAs during the study.
Measured: From first dose through 6 weeks after the last dose of study treatment
Peak Serum Concentration (Cmax) of BGM-2121
Cmax derived from serum concentration data.
Measured: From first dose through 30 days after the last dose
Area under Curve (AUC) of BGM-2121
AUC derived from serum concentration data.
Measured: From first dose through 30 days after the last dose
Objective Response Rate (ORR)
Percentage of subjects with complete or partial response according to RECIST 1.1 criteria.
Measured: From baseline through study completion, an average of 1 year
Progression-Free Survival (PFS)
Time from first treatment to documented disease progression or death.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start10 Mar 2026
- Primary completionNov 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioGate Precision Medicine Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07346846
- Sponsor's protocol ID
- BGM-2121-001
- Status last verified
- Apr 2026
- First submitted
- 25 Nov 2025
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 First-in-human Study of BGM-2121 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07346846
- Acronym / sponsor ID
- BGM-2121-001
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- BioGate Precision Medicine Corp.Industry (pharma, biotech, devices)
- Study start
- 10 Mar 2026 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 16 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to explore the safety, tolerability, pharmacokinetics, and preliminary efficacy of BGM-2121 in adult patients with advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BGM-2121 | Experimental | Drug: BGM-2121 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
- ...
Key exclusion criteria (4 listed)
- 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
- ...
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BGM-2121BGM-2121 treatment | Drug | BGM-2121 |
Primary outcome
Incidence of Dose-Limiting Toxicities (DLTs)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BGM-2121 in people with Advanced Solid Tumors, run by BioGate Precision Medicine Corp. at 3 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Queena Hwang (886-2-2517-6512 ext. 8556, clinical@biogate.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Dose-Limiting Toxicities (DLTs) (time frame: From first dose through the DLT evaluation period (28 days)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.