ASP546C for Gastric Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine the optimal dose of a new treatment, ASP546C, for individuals with certain cancers, including gastric cancer, gastroesophageal junction (GEJ) cancer, pancreatic cancer, and other solid tumors. The study consists of two parts. In Part 1, participants with gastric or GEJ cancer will receive either a higher or lower dose of ASP546C. In Part 2, participants with pancreatic or other specific tumors will receive a higher dose. This trial may suit those diagnosed with these cancers who have already undergone at least one treatment. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Do I need to stop my current medications for the ASP546C trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor to get specific guidance based on your situation.
Is there any evidence suggesting that ASP546C is likely to be safe for humans?
Research has shown that ASP546C is being tested for safety and effectiveness in treating stomach cancer and other solid tumors. Although limited information is available, the trial phase indicates that ASP546C has already undergone human testing, suggesting some level of safety.
ASP546C is administered as an infusion, slowly injected into a vein every three weeks. Similar treatments in past studies have generally been well-tolerated. However, specific side effects for ASP546C have not been detailed in the available information.
The study aims to find the best dose, focusing on the drug's safety and effectiveness. Participants may receive different doses to determine which is best tolerated with the fewest side effects. It is important to discuss any concerns with a doctor before joining a trial.12345Why do researchers think this study treatment might be promising for gastric cancer?
Researchers are excited about ASP546C because it offers a new approach to treating advanced gastric and other types of cancer. Unlike traditional chemotherapy, which kills rapidly dividing cells indiscriminately, ASP546C specifically targets cancer cells, potentially reducing damage to healthy cells and minimizing side effects. This precision targeting could lead to better outcomes for patients with cancers that are difficult to treat, like pancreatic adenocarcinoma and various pan-tumor types, including cholangiocarcinoma and colorectal adenocarcinoma. Additionally, ASP546C is administered intravenously every three weeks, which might improve convenience for patients compared to more frequent dosing schedules of some existing treatments.
What evidence suggests that ASP546C might be an effective treatment for gastric cancer?
Research has shown that ASP546C targets a protein called CLDN18.2, often present in certain cancers like stomach and pancreatic cancers. Early results suggest this method might work because the drug can attach to cancer cells and help destroy them. In this trial, participants with stomach cancer will receive either a lower or higher dose of ASP546C. Promising results from previous studies showed some tumors shrank. For pancreatic cancer, participants will receive a higher dose, and early data suggests better survival rates compared to past treatments. Although it's still early, these findings offer hope that ASP546C could be a promising treatment option for these difficult-to-treat cancers.12467
Who Is on the Research Team?
Study Physician
Principal Investigator
Astellas Pharma Global Development, Inc.
Are You a Good Fit for This Trial?
This trial is for adults with certain cancers (like stomach, esophagus, pancreas, bile duct, lung, colon, ovary or breast) whose tumors have a specific marker called CLDN18.2. Participants must be in good physical condition and not pregnant or breastfeeding. People with serious infections or other major health issues can't join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Part 1
Participants with gastric cancer or GEJ cancer receive ASP546C infusion every 3 weeks at either a higher or lower dose
Treatment Part 2
Participants with pancreatic cancer or other solid tumors receive ASP546C infusion every 3 weeks at a higher dose
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- ASP546C
Trial Overview
The study tests different doses of ASP546C given by IV infusion every three weeks to find the safest and most effective dose for people with advanced solid tumors such as gastric/GEJ cancer and pancreatic cancer. The study has two parts based on cancer type.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Participants with pan-tumor (cholangiocarcinoma, colorectal adenocarcinoma, NSCLC, SCLC, ovarian mucinous carcinoma or invasive breast cancer) will receive a higher dose of ASP546C intravenously, once Q3W.
Participants with uLA/m pancreatic adenocarcinoma will receive a higher dose of ASP546C intravenously, once Q3W.
Participants with uLA/m gastroesophageal adenocarcinoma will receive a higher dose of ASP546C intravenously, once Q3W.
Participants with unresectable locally advanced or metastatic (uLA/m) gastroesophageal adenocarcinoma will receive a lower dose of ASP546C intravenously, once every 3 weeks (Q3W).
Find a Clinic Near You
Who Is Running the Clinical Trial?
Astellas Pharma Global Development, Inc.
Lead Sponsor
Tadaaki Taniguchi
Astellas Pharma Global Development, Inc.
Chief Medical Officer
M.D., Ph.D.
Naoki Okamura
Astellas Pharma Global Development, Inc.
Chief Executive Officer
Not available
Citations
NCT07488676 | A Study of ASP546C in Adults With ...
This study will help find the most suitable dose of ASP546C in people with gastric cancer, gastroesophageal junction (GEJ) cancer, pancreatic cancer, ...
A study of ASP546C in adults with gastroesophageal ...
This study will help find the most suitable dose of ASP546C in people with gastric cancer, gastroesophageal junction (GEJ) cancer, pancreatic cancer, ...
A Phase 1b/2 Open-label Study to ... - Scholars@Duke grant
A Phase 1b/2 Open-label Study to Assess the Safety and Efficacy of ASP546C in Participants with CLDN18.2-expressing Locally Advanced ...
Comparative Effectiveness of Medical Therapies for Locally ...
Objectives: This systematic review (SR) aimed to evaluate the comparative effectiveness and harms of medical therapies for non-metastatic, locally advanced ...
ASP546C for Gastric Cancer
This study will help find the most suitable dose of ASP546C in people with gastric cancer, gastroesophageal junction (GEJ) cancer, ...
CTO-546C-CL-0201: Clinical Trial Information
A Phase 1b/2 Open-label Study to Assess the Safety and Efficacy of ASP546C in Participants with CLDN18.2-expressing Locally Advanced Unresectable or Metastatic ...
ASP546C / Evopoint, Astellas - Oncology
A Study of ASP546C in Adults With Gastroesophageal Cancer, Pancreatic Cancer ... P1/2 data • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology.
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.