A First-in-Human Study Using BDC-4182 as a Single Agent in Advanced Gastric and Gastroesophageal Cancer

January 23, 2026 updated by: Bolt Biotherapeutics, Inc.

A Phase 1/2, First-in-Human, Dose Escalation and Expansion Study of BDC-4182 as a Single Agent in Patients With Advanced Gastric and Gastroesophageal Cancer

A first-in-human study using BDC-4182 as a single agent in gastric and gastroesophageal cancers

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a dose escalation study designed to evaluate the safety and tolerability of BDC-4182 to establish the recommended Phase 2 dose (RP2D). Participants will be enrolled in each dose cohort until the maximum tolerated dose (MTD) is reached. Additional participants may be enrolled into backfill cohorts at dose levels that have been cleared to collect additional safety and tolerability data. Additional participants may be enrolled at the determined RP2D in an expansion portion of the study.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
122

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
    • New South Wales
      • Darlinghurst, New South Wales, Australia
        • Recruiting
        • AUS Site 2
        • Contact:
          • Site 8002
      • Westmead, New South Wales, Australia
        • Recruiting
        • AUS Site 5
        • Contact:
          • Site 8005
    • Queensland
      • Birtinya, Queensland, Australia
        • Recruiting
        • AUS Site 1
        • Contact:
          • Site 8001
    • Victoria
      • Clayton, Victoria, Australia
        • Recruiting
        • AUS Site 4
        • Contact:
          • Site 8004
      • Heidelberg, Victoria, Australia
        • Recruiting
        • AUS Site 3
        • Contact:
          • Site 8003
  • South Korea
      • Seongnam-si, South Korea
        • Recruiting
        • SK Site 2003
        • Contact:
          • Site 2003
      • Seoul, South Korea
        • Recruiting
        • SK Site 2001
        • Contact:
          • Site 2001
      • Seoul, South Korea
        • Recruiting
        • SK Site 2002
        • Contact:
          • Site 2002
      • Seoul, South Korea
        • Recruiting
        • SK Site 2004
        • Contact:
          • Site 2004
      • Seoul, South Korea
        • Recruiting
        • SK Site 2005
        • Contact:
          • Site 2005
  • Taiwan
      • Kaohsiung City, Taiwan
        • Recruiting
        • TWN Site 9004
        • Contact:
          • Site 9004
      • Kaohsiung City, Taiwan
        • Recruiting
        • TWN Site 9005
        • Contact:
          • Site 9005
      • Taichung, Taiwan
        • Recruiting
        • TWN Site 9001
        • Contact:
          • Site 9001
      • Taipei, Taiwan
        • Recruiting
        • TWN Site 9003
        • Contact:
          • Site 9003
      • Taipei, Taiwan
        • Recruiting
        • TWN Site 9006
        • Contact:
          • Site 9006
      • Taoyuan District, Taiwan
        • Recruiting
        • TWN Site 9002
        • Contact:
          • Site 9002

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 received at least 1-2 prior lines of locally available standard therapies or must be intolerant of standard therapies.
  • For subjects in escalation: If prior Claudin 18 IHC expression is known, the subject must have some degree of Claudin 18 expression as defined as Positive or have expression ≥ 1% of tumor cells IHC ≥ 2+. Consult with Medical Monitor as needed.
  • Adequate organ function
  • Agree to have a biopsy prior to enrollment, at acceptable risk in the judgement of the Investigator. If a biopsy is not safely accessible or clinically feasible, an adequate archival tumor sample must be submitted.

Key Exclusion Criteria:

  • Known central nervous system (CNS) metastases except for disease that is asymptomatic, clinically stable, and has not required steroids for at least 14 days before starting study treatment.
  • Cardiac disease, pulmonary disease, or hepatic disease
  • Active infection
  • History of inflammatory eye disease
  • Residual toxicity from a previous treatment
  • Any investigational agent or standard anti-cancer therapies within 28 days before starting study treatment or within 5 estimated elimination half-lives, whichever is shorter.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Dose Escalation
Escalating doses followed by backfill of selected doses
Drug: BDC-4182
Immune stimulating antibody conjugate (ISAC), consisting of an anti-claudin 18.2 monoclonal antibody conjugated to a TLR 7/8 dual agonist
Experimental: Dose Expansion
Expansion at determined RP2D
Drug: BDC-4182
Immune stimulating antibody conjugate (ISAC), consisting of an anti-claudin 18.2 monoclonal antibody conjugated to a TLR 7/8 dual agonist

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Time Frame: Up to 21 days
Escalation period
Up to 21 days
Incidence of adverse events (AEs) and serious adverse events (SAEs) graded according to CTCAE v5.0
Time Frame: approximately 2 years
Escalation period
approximately 2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Objective response rate (ORR) according to RECIST v. 1.1
Time Frame: approximately 4 years
Escalation and expansion periods
approximately 4 years
Duration of Response (DOR)
Time Frame: approximately 4 years
Escalation and expansion periods
approximately 4 years
Disease control rate (DCR)
Time Frame: approximately 4 years
Escalation and expansion periods
approximately 4 years
Progression-free survival (PFS)
Time Frame: approximately 4 years
Escalation and expansion periods
approximately 4 years
Best Overall Response (BOR)
Time Frame: approximately 4 years
Escalation and expansion periods
approximately 4 years
Overall survival (OS)
Time Frame: approximately 4 years
Escalation and expansion periods
approximately 4 years
PK (Cmax) of BDC-4182
Time Frame: approximately 4 years
Escalation and expansion periods
approximately 4 years
PK (Cmin) of BDC-4182
Time Frame: approximately 4 years
Escalation and expansion periods
approximately 4 years
PK (AUC0-tau) of BDC-4182
Time Frame: approximately 4 years
Escalation and expansion periods
approximately 4 years
PK (AUC0-inf) of BDC-4182
Time Frame: approximately 4 years
Escalation and expansion periods
approximately 4 years
PK (CL) of BDC-4182
Time Frame: approximately 4 years
Escalation and expansion periods
approximately 4 years
PK (Vc or Vss) of BDC-4182
Time Frame: approximately 4 years
Escalation and expansion periods
approximately 4 years
PK (Terminal half-life) of BDC-4182
Time Frame: approximately 4 years
Escalation and expansion periods
approximately 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bolt Biotherapeutics, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Bolt Clinical Development, Bolt Biotherapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 26, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 4, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 4, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 10, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BBI-4182-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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