Clinical Trials in Australia / NCT06921837
Recruiting
Phase 1/2
A First-in-Human Study Using BDC-4182 as a Single Agent in Advanced Gastric and Gastroesophageal Cancer
NCT06921837 · tracked via the Priya Life Science Australia tracker
Condition(s) studied
Gastric Cancer Adenocarcinoma MetastaticGastroesophageal Adenocarcinoma
Investigational drug(s) / intervention(s)
BDC-4182
BDC-4182: Immune stimulating antibody conjugate (ISAC), consisting of an anti-claudin 18.2 monoclonal antibody conjugated to a TLR 7/8 dual agonist
Study summary
A first-in-human study using BDC-4182 as a single agent in gastric and gastroesophageal cancers
Eligibility
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.
Primary outcome measure(s)
- Incidence of adverse events (AEs) and serious adverse events (SAEs) graded according to CTCAE v5.0 — 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 — Up to 21 days
Escalation period
Trial sites (16)
| Facility | City | Region | Status |
|---|---|---|---|
| AUS Site 2 | Darlinghurst | New South Wales | Recruiting |
| AUS Site 5 | Westmead | New South Wales | Recruiting |
| AUS Site 1 | Birtinya | Queensland | Recruiting |
| AUS Site 4 | Clayton | Victoria | Recruiting |
| AUS Site 3 | Heidelberg | Victoria | 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 | Taiwan | Recruiting |
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06921837 on ClinicalTrials.gov ↗ ← All trials in Australia