150 Participants NeededMy employer runs this trial

ASP546C for Gastric Cancer

Recruiting at 16 trial locations
AP
Overseen ByAstellas Pharma Global Development, Inc
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Astellas Pharma Global Development, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

Why 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?

SP

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

I have a recent scan confirming advanced gastroesophageal or pancreatic cancer.
Participant must meet all of the criteria based on the locally analyzed laboratory tests collected within 14 days prior to the first dose of study intervention. In case of multiple local laboratory tests within this period, the most recent data should be used.
My tumor tests positive for CLDN18.2.
See 14 more

Exclusion Criteria

I have had more than two previous treatments for my advanced or metastatic cancer.
I have a blockage in my stomach that causes ongoing vomiting.
I have had serious stomach bleeding or an untreated ulcer in the past 3 months.
See 24 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part 1

Participants with gastric cancer or GEJ cancer receive ASP546C infusion every 3 weeks at either a higher or lower dose

Up to 39 months
Clinic visits every 3 weeks for infusion and health checks

Treatment Part 2

Participants with pancreatic cancer or other solid tumors receive ASP546C infusion every 3 weeks at a higher dose

Up to 39 months
Clinic visits every 3 weeks for infusion and health checks

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 4 weeks

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

Group I: Part 2 - Cohort 4 ASP546C Higher DoseExperimental Treatment1 Intervention
Group II: Part 2 - Cohort 3 ASP546C Higher DoseExperimental Treatment1 Intervention
Group III: Part 1 - Cohort 2 ASP546C Higher DoseExperimental Treatment1 Intervention
Group IV: Part 1 - Cohort 1 ASP546C Lower DoseExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Astellas Pharma Global Development, Inc.

Lead Sponsor

Trials
204
Recruited
123,000+

Tadaaki Taniguchi

Astellas Pharma Global Development, Inc.

Chief Medical Officer

M.D., Ph.D.

Naoki Okamura profile image

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 ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41838838/

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.