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Recruiting NCT06921837

A First-in-Human Study Using BDC-4182 as a Single Agent in Advanced Gastric and Gastroesophageal Cancer

Phase I / Phase II Interventional Gastric Cancer Adenocarcinoma Metastatic Gastroesophageal Adenocarcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: BDC-4182.
Who it may be relevant to
Registry conditions: Gastric Cancer Adenocarcinoma Metastatic, Gastroesophageal Adenocarcinoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Australia, South Korea, Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Drug BDC-4182
    Immune stimulating antibody conjugate (ISAC), consisting of an anti-claudin 18.2 monoclonal antibody conjugated to a TLR 7/8 dual agonist

Primary outcome measures

  • Incidence of adverse events (AEs) and serious adverse events (SAEs) graded according to CTCAE v5.0 [Time frame: 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 [Time frame: Up to 21 days]
Secondary outcome measures (12)
  • 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]

Eligibility criteria

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.

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

Taiwan · 6 centers
  • TWN Site 9004 — Kaohsiung City
  • TWN Site 9005 — Kaohsiung City
  • TWN Site 9001 — Taichung
  • TWN Site 9003 — Taipei
  • TWN Site 9006 — Taipei
  • TWN Site 9002 — Taoyuan
Australia · 5 centers
  • AUS Site 2 — Darlinghurst
  • AUS Site 5 — Westmead
  • AUS Site 1 — Birtinya
  • AUS Site 4 — Clayton
  • AUS Site 3 — Heidelberg
South Korea · 5 centers
  • SK Site 2003 — Seongnam-si
  • SK Site 2001 — Seoul
  • SK Site 2002 — Seoul
  • SK Site 2004 — Seoul
  • SK Site 2005 — Seoul

Identifiers

NCT: NCT06921837 · BBI-4182-101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗