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BDC-4182

Phase 1

Gastric Cancer Adenocarcinoma Metastatic | Small molecule | Oncology |Bolt Biotherapeutics, Inc.|Last Updated: Jan 27, 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
CONTROLLEDBiomarker
Total Trials1
Total Enrollment122
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06921837A First-in-Human Study Using BDC-4182 as a Single Agent in Advanced Gastric and Gastroesophageal CancerPHASE1 RECRUITING 122 — — May 26, 2025May 1, 2029Jan 27, 202616 Australia, South Korea +1
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Study Endpoints
Primary Endpoints
Incidence of adverse events (AEs) and serious adverse events (SAEs) graded according to CTCAE v5.0
approximately 2 years

Escalation period

Incidence and nature of AEs considered by the Investigator or Sponsor to be clinically relevant, attributable to study treatment, and meeting dose-limiting toxicity (DLT) criteria
Up to 21 days

Escalation period

Secondary Endpoints
Objective response rate (ORR) according to RECIST v. 1.1
approximately 4 years
Duration of Response (DOR)
approximately 4 years
Disease control rate (DCR)
approximately 4 years
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Dose EscalationEXPERIMENTALEscalating doses followed by backfill of selected doses
Dose ExpansionEXPERIMENTALExpansion at determined RP2D
Interventions
NameTypeDescription
BDC-4182DRUGImmune stimulating antibody conjugate (ISAC), consisting of an anti-claudin 18.2 monoclonal antibody conjugated to a TLR 7/8 dual agonist
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites16

Key Inclusion Criteria: * Has disease that is measurable by Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1. * Subjects must have histologically/cytologically confirmed gastric or gastroesophageal cancer that is metastatic (Stage 4) or unresectable (Stage 3). * Subjects must have receiv...

Countries:AustraliaSouth KoreaTaiwan
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06921837primaryCompletionDate: changed
LOWMay 24, 2026NCT06921837studyFirstPostDate: changed