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BGM-2121

Phase 1

Advanced Solid Tumors | Small molecule | Oncology |Precision BioSciences, Inc.|Last Updated: Apr 21, 2026

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment35

FDA Designations

No designations recorded

Clinical trial landscape

BGM-2121 · 1 trial · 1 indication

Phase 1 1
NCT07346846A Study of BGM-2121 in Patients With Advanced Solid TumorsAdvanced Solid Tumors
RECRUITING35 Analytics
PHASE1RECRUITING
A Study of BGM-2121 in Patients With Advanced Solid Tumors
Advanced Solid Tumors
NCT0734684635
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Study Endpoints

Primary Endpoints

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 Endpoints

Determination of Maximum Tolerated Dose (MTD) to establish RP2D
From first dose through the DLT evaluation period (28 days)
Incidence of Anti-Drug Antibodies (ADAs)
From first dose through 6 weeks after the last dose of study treatment
Peak Serum Concentration (Cmax) of BGM-2121
From first dose through 30 days after the last dose
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
BGM-2121EXPERIMENTAL -

Interventions

NameTypeDescription
BGM-2121DRUGBGM-2121 treatment
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites3

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....

Countries:Taiwan
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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Advanced Solid Tumors")

CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK2PHASE2pembrolizumab
Incyte CorporationINCY1PHASE2Chemotherapy, Retifanlimab
Iovance Biotherapeutics IncIOVA2PHASE2E7 TCR-T cells, Aldesleukin
Novartis AG Sponsored ADRNVS1PHASE1KFA115, pembrolizumab
AstraZeneca PLCAZN1 - Trastuzumab deruxtecan
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Frequently asked questions about BGM-2121

What is BGM-2121 used for?

BGM-2121 is an investigational small molecule being developed for the treatment of advanced solid tumors. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being studied in patients with advanced solid tumors to evaluate its safety and potential efficacy.

Who makes BGM-2121?

BGM-2121 is being developed by Precision BioSciences, Inc., a biopharmaceutical company. The company is listed on the stock exchange under the ticker symbol DTIL. Precision BioSciences is conducting clinical trials to evaluate the safety and efficacy of BGM-2121 in patients with advanced solid tumors.

What phase is BGM-2121 in?

BGM-2121 is currently in Phase 1 clinical development. It is an investigational drug and has not received regulatory approval. The ongoing Phase 1 trial is recruiting patients with advanced solid tumors to assess the drug's safety, tolerability, and preliminary activity.

What clinical trials is BGM-2121 in?

BGM-2121 is being studied in a Phase 1 clinical trial with the identifier NCT07346846, titled "A Study of BGM-2121 in Patients With Advanced Solid Tumors." The trial is currently recruiting participants in Taiwan and aims to enroll 35 patients aged 18 years and older.

Is BGM-2121 FDA approved?

BGM-2121 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The drug is being studied in a clinical trial for advanced solid tumors, but it has not yet completed the clinical trials and regulatory review process required for approval.

Is BGM-2121 a small molecule?

Yes, BGM-2121 is a small molecule drug. It is being developed as an oncology treatment for advanced solid tumors. The drug is currently in Phase 1 clinical trials, and its mechanism of action has not been disclosed in available information.