Gastric Cancer Adenocarcinoma Metastatic study: BDC-4182
Official title A First-in-Human Study Using BDC-4182 as a Single Agent in Advanced Gastric and Gastroesophageal Cancer
ClinicalTrials.gov ID: NCT06921837
What this study is testing
What is BDC-4182?
BDC-4182 is an investigational medicine, being studied as a potential treatment for gastric cancer adenocarcinoma metastatic.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A first-in-human study using BDC-4182 as a single agent in gastric and gastroesophageal cancers
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Has disease that is measurable by Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1.
- people must have histologically/cytologically confirmed gastric or gastroesophageal cancer that is metastatic (Stage 4) or unresectable (Stage 3).
- people must have received at least 1-2 prior lines of locally available standard therapies or must be intolerant of standard therapies.
- For people in escalation: If prior Claudin 18 IHC expression is known, the subject must have some degree of Claudin 18 expression as defined as...
- Adequate organ function
You likely can't join if
- Known central nervous system (CNS) metastases except for disease that is asymptomatic, clinically stable, and has not required steroids for at least...
- 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...
See the full eligibility criteria
- Has disease that is measurable by Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1.
- people must have histologically/cytologically confirmed gastric or gastroesophageal cancer that is metastatic (Stage 4) or unresectable (Stage 3).
- people must have received at least 1-2 prior lines of locally available standard therapies or must be intolerant of standard therapies.
- For people 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+.
- 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
- 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 study team makes the final eligibility decision.
Where it is enrolling
- Darlinghurst, New South Wales, Australia
- Westmead, New South Wales, Australia
- Birtinya, Queensland, Australia
- Clayton, Victoria, Australia
- Heidelberg, Victoria, Australia
- Seongnam-si, South Korea
- Seoul, South Korea
- Kaohsiung City, Taiwan
- Taichung, Taiwan
- Taipei, Taiwan
- Taoyuan, Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Darlinghurst, New South Wales, Australia; Westmead, New South Wales, Australia; Birtinya, Queensland, Australia; Clayton, Victoria, Australia; Heidelberg, Victoria, Australia; Seongnam-si, South Korea and 5 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.