NCT06921837

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P75+ for phase_1

Timeline
36mo left

Started May 2025

Longer than P75 for phase_1

Geographic Reach
3 countries

16 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress24%
May 2025May 2029

First Submitted

Initial submission to the registry

April 4, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 10, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

May 26, 2025

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2029

Last Updated

January 27, 2026

Status Verified

November 1, 2025

Enrollment Period

1.9 years

First QC Date

April 4, 2025

Last Update Submit

January 23, 2026

Conditions

Gastric Cancer Adenocarcinoma MetastaticGastroesophageal Adenocarcinoma

Keywords

Gastric CancerGastroesophageal Cancer

Outcome Measures

Primary Outcomes (2)

  • Incidence of adverse events (AEs) and serious adverse events (SAEs) graded according to CTCAE v5.0

    Escalation period

    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

    Up to 21 days

Secondary Outcomes (13)

  • 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

  • Progression-free survival (PFS)

    approximately 4 years

  • Best Overall Response (BOR)

    approximately 4 years

  • +8 more secondary outcomes

Study Arms (2)

Dose Escalation

EXPERIMENTAL

Escalating doses followed by backfill of selected doses

Drug: BDC-4182

Dose Expansion

EXPERIMENTAL

Expansion at determined RP2D

Drug: BDC-4182

Interventions

BDC-4182DRUG

Immune stimulating antibody conjugate (ISAC), consisting of an anti-claudin 18.2 monoclonal antibody conjugated to a TLR 7/8 dual agonist

Dose EscalationDose Expansion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

AUS Site 2

Darlinghurst, New South Wales, Australia

RECRUITING

AUS Site 5

Westmead, New South Wales, Australia

RECRUITING

AUS Site 1

Birtinya, Queensland, Australia

RECRUITING

AUS Site 4

Clayton, Victoria, Australia

RECRUITING

AUS Site 3

Heidelberg, Victoria, Australia

RECRUITING

SK Site 2003

Seongnam-si, South Korea

RECRUITING

SK Site 2001

Seoul, South Korea

RECRUITING

SK Site 2002

Seoul, South Korea

RECRUITING

SK Site 2004

Seoul, South Korea

RECRUITING

SK Site 2005

Seoul, South Korea

RECRUITING

TWN Site 9004

Kaohsiung City, Taiwan

RECRUITING

TWN Site 9005

Kaohsiung City, Taiwan

RECRUITING

TWN Site 9001

Taichung, Taiwan

RECRUITING

TWN Site 9003

Taipei, Taiwan

RECRUITING

TWN Site 9006

Taipei, Taiwan

RECRUITING

TWN Site 9002

Taoyuan District, Taiwan

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Bolt Clinical Development

    Bolt Biotherapeutics

    STUDY DIRECTOR

Central Study Contacts

Bolt Biotherapeutics

CONTACT

+1 650 434 8640clinicaltrials@boltbio.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2025

First Posted

April 10, 2025

Study Start

May 26, 2025

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2029

Last Updated

January 27, 2026

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

AU(5)TW(6)KR(5)