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RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

Who May Be Eligible (Plain English)

Key Who May Qualify: - 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. - your organs (liver, kidneys, etc.) are working well enough based on blood tests - 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 Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

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

Locations (16)

AUS Site 2
Darlinghurst, New South Wales, Australia
AUS Site 5
Westmead, New South Wales, Australia
AUS Site 1
Birtinya, Queensland, Australia
AUS Site 4
Clayton, Victoria, Australia
AUS Site 3
Heidelberg, Victoria, Australia
SK Site 2003
Seongnam-si, South Korea
SK Site 2001
Seoul, South Korea
SK Site 2002
Seoul, South Korea
SK Site 2004
Seoul, South Korea
SK Site 2005
Seoul, South Korea
TWN Site 9004
Kaohsiung City, Taiwan
TWN Site 9005
Kaohsiung City, Taiwan
TWN Site 9001
Taichung, Taiwan
TWN Site 9003
Taipei, Taiwan
TWN Site 9006
Taipei, Taiwan
TWN Site 9002
Taoyuan District, Taiwan