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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06921837




Registration number
NCT06921837
Ethics application status
Date submitted
4/04/2025
Date registered
10/04/2025

Titles & IDs
Public title
A First-in-Human Study Using BDC-4182 as a Single Agent in Advanced Gastric and Gastroesophageal Cancer
Scientific 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
Secondary ID [1] 0 0
BBI-4182-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastric Cancer Adenocarcinoma Metastatic 0 0
Gastroesophageal Adenocarcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Stomach

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BDC-4182

Experimental: Dose Escalation - Escalating doses followed by backfill of selected doses

Experimental: Dose Expansion - Expansion at determined RP2D


Treatment: Drugs: BDC-4182
Immune stimulating antibody conjugate (ISAC), consisting of an anti-claudin 18.2 monoclonal antibody conjugated to a TLR 7/8 dual agonist
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of adverse events (AEs) and serious adverse events (SAEs) graded according to CTCAE v5.0
Timepoint [1] 0 0
approximately 2 years
Primary outcome [2] 0 0
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
Timepoint [2] 0 0
Up to 21 days
Secondary outcome [1] 0 0
Objective response rate (ORR) according to RECIST v. 1.1
Timepoint [1] 0 0
approximately 4 years
Secondary outcome [2] 0 0
Duration of Response (DOR)
Timepoint [2] 0 0
approximately 4 years
Secondary outcome [3] 0 0
Disease control rate (DCR)
Timepoint [3] 0 0
approximately 4 years
Secondary outcome [4] 0 0
Progression-free survival (PFS)
Timepoint [4] 0 0
approximately 4 years
Secondary outcome [5] 0 0
Best Overall Response (BOR)
Timepoint [5] 0 0
approximately 4 years
Secondary outcome [6] 0 0
Overall survival (OS)
Timepoint [6] 0 0
approximately 4 years
Secondary outcome [7] 0 0
PK (Cmax) of BDC-4182
Timepoint [7] 0 0
approximately 4 years
Secondary outcome [8] 0 0
PK (Cmin) of BDC-4182
Timepoint [8] 0 0
approximately 4 years
Secondary outcome [9] 0 0
PK (AUC0-tau) of BDC-4182
Timepoint [9] 0 0
approximately 4 years
Secondary outcome [10] 0 0
PK (AUC0-inf) of BDC-4182
Timepoint [10] 0 0
approximately 4 years
Secondary outcome [11] 0 0
PK (CL) of BDC-4182
Timepoint [11] 0 0
approximately 4 years
Secondary outcome [12] 0 0
PK (Vc or Vss) of BDC-4182
Timepoint [12] 0 0
approximately 4 years
Secondary outcome [13] 0 0
PK (Terminal half-life) of BDC-4182
Timepoint [13] 0 0
approximately 4 years

Eligibility
Key inclusion criteria
Key

* 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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 design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/05/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/05/2029
Actual
Sample size
Target
122
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
AUS Site 2 - Darlinghurst
Recruitment hospital [2] 0 0
AUS Site 1 - Birtinya
Recruitment postcode(s) [1] 0 0
- Darlinghurst
Recruitment postcode(s) [2] 0 0
- Birtinya

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bolt Biotherapeutics, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bolt Clinical Development
Address 0 0
Bolt Biotherapeutics
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Bolt Biotherapeutics
Address 0 0
Country 0 0
Phone 0 0
+1 650 434 8640
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06921837