Gastric Cancer Adenocarcinoma MetastaticPhase 1/2NCT06921837
A First-in-Human Study Using BDC-4182 as a Single Agent in Advanced Gastric and Gastroesophageal Cancer
A Phase 1/2 study testing BDC-4182 in people with Gastric Cancer Adenocarcinoma Metastatic and Gastroesophageal Adenocarcinoma, run by Bolt Biotherapeutics, Inc. at 16 sites in 3 countries.
Trial summary
A first-in-human study using BDC-4182 as a single agent in gastric and gastroesophageal cancers Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer Adenocarcinoma Metastatic, Gastroesophageal Adenocarcinoma
- What is being tested?
- BDC-4182
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 16 sitesin 3 countries
- Study dates
- 26 May 2025to May 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
16 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
16 sites in 3 countries
Taiwan6 sites, 6 recruiting
- Recruiting
TWN Site 9004
Kaohsiung City
Site 9004
- Recruiting
TWN Site 9005
Kaohsiung City
Site 9005
- Recruiting
TWN Site 9001
Taichung
Site 9001
- Recruiting
TWN Site 9003
Taipei
Site 9003
- Recruiting
TWN Site 9006
Taipei
Site 9006
- Recruiting
TWN Site 9002
Taoyuan
Site 9002
Australia5 sites, 5 recruiting
- Recruiting
AUS Site 1
Birtinya, Queensland
Site 8001
- Recruiting
AUS Site 4
Clayton, Victoria
Site 8004
- Recruiting
AUS Site 2
Darlinghurst, New South Wales
Site 8002
- Recruiting
AUS Site 3
Heidelberg, Victoria
Site 8003
- Recruiting
AUS Site 5
Westmead, New South Wales
Site 8005
South Korea5 sites, 5 recruiting
- Recruiting
SK Site 2003
Seongnam-si
Site 2003
- Recruiting
SK Site 2001
Seoul
Site 2001
- Recruiting
SK Site 2002
Seoul
Site 2002
- Recruiting
SK Site 2004
Seoul
Site 2004
- Recruiting
SK Site 2005
Seoul
Site 2005
About this study
Official title: 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
Read the 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.
- Being tested
- BDC-4182
- Keywords
- Gastric Cancer, Gastroesophageal Cancer
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BDC-4182Drug
Immune stimulating antibody conjugate (ISAC), consisting of an anti-claudin 18.2 monoclonal antibody conjugated to a TLR 7/8 dual agonist
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation | Experimental | Escalating doses followed by backfill of selected doses Receives: Drug: BDC-4182 |
| Dose Expansion | Experimental | Expansion at determined RP2D Receives: Drug: BDC-4182 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (AEs) and serious adverse events (SAEs) graded according to CTCAE v5.0
Escalation period
Measured: approximately 2 years
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
Escalation period
Measured: Up to 21 days
Secondary outcomes (13)
Objective response rate (ORR) according to RECIST v. 1.1
Escalation and expansion periods
Measured: approximately 4 years
Duration of Response (DOR)
Escalation and expansion periods
Measured: approximately 4 years
Disease control rate (DCR)
Escalation and expansion periods
Measured: approximately 4 years
Progression-free survival (PFS)
Escalation and expansion periods
Measured: approximately 4 years
Best Overall Response (BOR)
Escalation and expansion periods
Measured: approximately 4 years
Overall survival (OS)
Escalation and expansion periods
Measured: approximately 4 years
PK (Cmax) of BDC-4182
Escalation and expansion periods
Measured: approximately 4 years
PK (Cmin) of BDC-4182
Escalation and expansion periods
Measured: approximately 4 years
PK (AUC0-tau) of BDC-4182
Escalation and expansion periods
Measured: approximately 4 years
PK (AUC0-inf) of BDC-4182
Escalation and expansion periods
Measured: approximately 4 years
PK (CL) of BDC-4182
Escalation and expansion periods
Measured: approximately 4 years
PK (Vc or Vss) of BDC-4182
Escalation and expansion periods
Measured: approximately 4 years
PK (Terminal half-life) of BDC-4182
Escalation and expansion periods
Measured: approximately 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start26 May 2025
- Primary completionMay 2027 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Cancer Adenocarcinoma MetastaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bolt Biotherapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bolt Clinical Development, Study director, Bolt Biotherapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06921837
- Sponsor's protocol ID
- BBI-4182-101
- Status last verified
- Nov 2025
- First submitted
- 4 Apr 2025
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06921837
- Acronym / sponsor ID
- BBI-4182-101
- Keywords
- Gastric Cancer, Gastroesophageal Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- Bolt Biotherapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 26 May 2025 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 10 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A first-in-human study using BDC-4182 as a single agent in gastric and gastroesophageal cancers
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation | Experimental | Drug: BDC-4182Escalating doses followed by backfill of selected doses |
| Dose Expansion | Experimental | Drug: BDC-4182Expansion at determined RP2D |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BDC-4182Immune stimulating antibody conjugate (ISAC), consisting of an anti-claudin 18.2 monoclonal antibody conjugated to a TLR 7/8 dual agonist | Drug | Dose Escalation, Dose Expansion |
Primary outcome
Incidence of adverse events (AEs) and serious adverse events (SAEs) graded according to CTCAE v5.0
Time frame: 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
Time frame: Up to 21 days
Escalation period
13 secondary outcomes
Objective response rate (ORR) according to RECIST v. 1.1
Time frame: approximately 4 years
Duration of Response (DOR)
Time frame: approximately 4 years
Disease control rate (DCR)
Time frame: approximately 4 years
Progression-free survival (PFS)
Time frame: approximately 4 years
Best Overall Response (BOR)
Time frame: approximately 4 years
Overall survival (OS)
Time frame: approximately 4 years
PK (Cmax) of BDC-4182
Time frame: approximately 4 years
PK (Cmin) of BDC-4182
Time frame: approximately 4 years
PK (AUC0-tau) of BDC-4182
Time frame: approximately 4 years
PK (AUC0-inf) of BDC-4182
Time frame: approximately 4 years
PK (CL) of BDC-4182
Time frame: approximately 4 years
PK (Vc or Vss) of BDC-4182
Time frame: approximately 4 years
PK (Terminal half-life) of BDC-4182
Time frame: approximately 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bolt Clinical Development study director
Bolt Biotherapeutics
16 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BDC-4182 in people with Gastric Cancer Adenocarcinoma Metastatic and Gastroesophageal Adenocarcinoma, run by Bolt Biotherapeutics, Inc. at 16 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Taiwan, Australia, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bolt Biotherapeutics (+1 650 434 8640, clinicaltrials@boltbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (AEs) and serious adverse events (SAEs) graded according to CTCAE v5.0 (time frame: approximately 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.