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BGM-2121

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDDMC
Total Trials1
Total Enrollment35
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07346846A Study of BGM-2121 in Patients With Advanced Solid TumorsPHASE1 RECRUITING 35 — — Mar 10, 2026Dec 1, 2028Apr 21, 20263 Taiwan
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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 — 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
CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK2PHASE2pembrolizumab, V503, GARDASIL
Incyte CorporationINCY1PHASE2Chemotherapy, Retifanlimab
Novartis AG Sponsored ADRNVS1PHASE1KFA115, pembrolizumab
Iovance Biotherapeutics IncIOVA2PHASE2E7 TCR-T cells, Aldesleukin
AstraZeneca PLCAZN1 — Trastuzumab deruxtecan
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT07346846studyFirstPostDate: changed