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Clinical Trials List

Protocol NumberBBI-4182-101

NCT Number(ClinicalTrials.gov Identfier)NCT06921837

Active

2025-09-01 - 2027-05-31

Phase I/II

Recruiting6

ICD-10C16.0

Malignant neoplasm of cardia

ICD-10C7A.092

Malignant carcinoid tumor of the stomach

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9151.0

Malignant neoplasm of cardia of stomach

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

Trial Applicant
Sponsor

NOVOTECH CLINICAL RESEARCH TAIWAN PTY LTD.
Trial scale

Multi-Regional Multi-Center
Update

2026/09/11

Investigators and Locations

Principal Investigator Chia-Chi Lin 無

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 陳彥仰無

Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Ming-Huang Chen 無

Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Li-Yuan Bai 無

China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator I-CHEN WU 無

Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Wen-Chi Chou

Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Gastric Cancer Adenocarcinoma Metastatic Gastroesophageal Adenocarcinoma

Objectives

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

Test Drug

BDC-4182

Active Ingredient

BDC-4182

Dosage Form

Lyophilized powder for injection

Dosage

125mg/5mL

Endpoints

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

Inclution 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.

The Estimated Number of Participants

Taiwan

16 participants
Global

120 participants