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New drug BDC-4182 targets stomach cancer by waking up the immune system

NCT ID NCT06921837

Disease control Sponsor: Bolt Biotherapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase trial is testing a new drug called BDC-4182 in people with advanced gastric or gastroesophageal cancer that has spread or cannot be removed. The drug is designed to attach to a protein on cancer cells and stimulate the immune system to attack them. The study will enroll 122 participants to check safety and see if the drug can shrink tumors.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BDC-4182, an immune-stimulating antibody conjugate that targets claudin 18.2 on cancer cells and activates the immune system
What this could lead to
If successful, this could lead to a new treatment option for advanced gastric and gastroesophageal cancers that have stopped responding to standard therapies.
What could go wrong
This is an early first-in-human trial, so safety and effectiveness are not yet known. The drug may cause side effects or fail to shrink tumors. Results may not apply to all patients.
Why investors are watching

Bolt Biotherapeutics is testing its drug BDC-4182 as a single treatment for advanced gastric and gastroesophageal cancers in a first-in-human study. For a micro-cap company with few other products, this early-stage readout is the main driver of its value, and the result will show whether the drug is safe and worth advancing.

If it works: If the drug shows acceptable safety and signs of controlling the cancer, Bolt could move to a larger study and attract partnership interest. That would validate its technology and give the company a path forward.

If it fails: Most first-in-human cancer drugs fail, and a poor safety or efficacy result could force Bolt to abandon BDC-4182. With no other late-stage assets mentioned, a failure would leave the company without a clear clinical candidate.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 122 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

May 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

gastric adenocarcinoma gastric cancer gastric neoplasm gastroesophageal adenocarcinoma gastroesophageal cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Gastric cancer adenocarcinoma metastatic Gastroesophageal adenocarcinoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    16 sites in 3 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • AUS Site 1

    RECRUITING

    Birtinya, Queensland, Australia

  • AUS Site 2

    RECRUITING

    Darlinghurst, New South Wales, Australia

  • AUS Site 3

    RECRUITING

    Heidelberg, Victoria, Australia

  • AUS Site 4

    RECRUITING

    Clayton, Victoria, Australia

  • AUS Site 5

    RECRUITING

    Westmead, New South Wales, Australia

  • SK Site 2001

    RECRUITING

    Seoul, South Korea

  • SK Site 2002

    RECRUITING

    Seoul, South Korea

  • SK Site 2003

    RECRUITING

    Seongnam-si, South Korea

  • SK Site 2004

    RECRUITING

    Seoul, South Korea

  • SK Site 2005

    RECRUITING

    Seoul, South Korea

  • TWN Site 9001

    RECRUITING

    Taichung, Taiwan

  • TWN Site 9002

    RECRUITING

    Taoyuan, Taiwan

  • TWN Site 9003

    RECRUITING

    Taipei, Taiwan

  • TWN Site 9004

    RECRUITING

    Kaohsiung City, Taiwan

  • TWN Site 9005

    RECRUITING

    Kaohsiung City, Taiwan

  • TWN Site 9006

    RECRUITING

    Taipei, Taiwan

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