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BDC-4182

Phase 1

Gastric Cancer Adenocarcinoma Metastatic | Small molecule | Oncology |Bolt Biotherapeutics, Inc.|Last Updated: Jan 27, 2026

Development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Apr 2025

Target and mechanism

Molecular targetclaudin 18.2
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment122

FDA Designations

No designations recorded

Clinical trial landscape

BDC-4182 · 1 trial · 2 indications

Phase 1 1
NCT06921837A First-in-Human Study Using BDC-4182 as a Single Agent in Advanced Gastric and Gastroesophageal CancerGastric Cancer Adenocarcinoma Metastatic
RECRUITING122 Analytics
PHASE1RECRUITING
A First-in-Human Study Using BDC-4182 as a Single Agent in Advanced Gastric and Gastroesophageal Cancer
Gastric Cancer Adenocarcinoma MetastaticUnlock trial analytics

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 to 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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Frequently asked questions about BDC-4182

What is BDC-4182 used for?

BDC-4182 is an investigational small molecule being developed for the treatment of metastatic gastric cancer adenocarcinoma and gastroesophageal adenocarcinoma. It is currently being studied in a first-in-human Phase 1 clinical trial as a single agent in patients with these advanced cancers.

What does BDC-4182 target?

BDC-4182 targets claudin 18.2, a protein that is often expressed in gastric and gastroesophageal cancers. By targeting this protein, the drug aims to interfere with cancer cell growth and survival. It is being evaluated as a monotherapy in a Phase 1 clinical trial.

Who is developing BDC-4182?

BDC-4182 is being developed by Bolt Biotherapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol BOLT. The company is conducting a Phase 1 clinical trial to evaluate the drug as a single agent in advanced gastric and gastroesophageal cancer.

What phase is BDC-4182 in?

BDC-4182 is in Phase 1 clinical development. It is an investigational drug, not yet approved by regulatory authorities. The ongoing Phase 1 trial is a first-in-human study designed to assess the safety, tolerability, and preliminary efficacy of BDC-4182 as a single agent.

What clinical trials is BDC-4182 in?

BDC-4182 is being studied in a single active Phase 1 clinical trial with the identifier NCT06921837. The trial, titled "A First-in-Human Study Using BDC-4182 as a Single Agent in Advanced Gastric and Gastroesophageal Cancer," is currently recruiting participants in Australia, South Korea, and Taiwan.

Is BDC-4182 the same as other claudin 18.2-targeting drugs?

BDC-4182 is a distinct investigational small molecule that targets claudin 18.2. It is being developed by Bolt Biotherapeutics and is not known to be the same as any other drug. Its unique mechanism and development program are being evaluated in a Phase 1 clinical trial.