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ASP2138 for Digestive System Cancers
Phase 1
Recruiting
Research Sponsored by Astellas Pharma Global Development, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participant's tumor sample is positive for claudin (CLDN)18.2 expression by central immunohistochemistry (IHC) testing.
Participant has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 21 months
Awards & highlights
Study Summary
This trialstudies ASP2138 for treating stomach, gastroesophageal junction, and pancreatic cancer. Participants will receive ASP2138 in two phases to find a safe dose and understand how it works. Participants must be 18 or older.
Who is the study for?
Adults with advanced stomach, gastroesophageal junction, or pancreatic cancer that can't be removed by surgery or has spread are eligible. They must not be pregnant or breastfeeding and agree to contraception. Their tumors should express CLDN18.2 protein and they should have a life expectancy of at least 12 weeks.Check my eligibility
What is being tested?
The trial is testing ASP2138, which targets both the tumor cell and an immune cell protein to direct the immune system against the tumor. It's given as an infusion in two phases: first to find a safe dose by escalating amounts in small groups, then using those doses to see how different cancers respond.See study design
What are the potential side effects?
Potential side effects aren't detailed but may include reactions related to infusions through veins, impacts on organ functions due to immune responses, and general discomfort from treatment such as fatigue or digestive issues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My tumor tested positive for CLDN18.2.
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I am fully active or restricted in physically strenuous activity but can do light work.
Select...
I am not pregnant, confirmed by a blood test and doctor's evaluation.
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I have been diagnosed with pancreatic cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 21 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 21 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Dose Limiting Toxicities (DLTs) (Phase 1 Dose Escalation)
Number of participants at each grade of the Eastern Cooperative Oncology Group (ECOG) performance status
Number of participants with Adverse Events (AEs)
+5 moreSecondary outcome measures
Change from baseline in claudin (CLDN) 18.2 tumor expression level
Change from baseline in programmed death-ligand 1 (PD-L1) tumor expression level
Change from baseline in serum carbohydrate antigen 19-9 (CA19-9) (pancreatic only) (Phase 1b dose expansion)
+6 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Dose Expansion (Phase 1b) Pancreatic cancerExperimental Treatment1 Intervention
Participants will receive ASP2138 at the RP2D regimens determined in Dose Escalation arm.
Group II: Dose Expansion (Phase 1b) Gastric/GEJ cancerExperimental Treatment1 Intervention
Participants will receive ASP2138 at the RP2D regimens determined in Dose Escalation arm.
Group III: Dose Escalation (Phase 1)Experimental Treatment1 Intervention
A dose escalation design will be used to determine the Maximum Tolerated Dose (MTD) and/ or the Recommended Phase 2 Dose (RP2D) regimens to be further evaluated in the Dose Expansion arms.
Dose escalation part consists of six parts (Part A, B, C, D, E, and F), and up to 75 patients would be enrolled in total. Participants will be assigned to sequentially escalating dose cohorts of ASP2138 in each part. The study will open with the Part A dosing schedule, while subsequent cohorts will be opened sequentially or in parallel based upon sponsor review of emerging data.
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Who is running the clinical trial?
Astellas Pharma Global Development, Inc.Lead Sponsor
192 Previous Clinical Trials
120,811 Total Patients Enrolled
Senior DirectorStudy DirectorAstellas Pharma Global Development, Inc.
9 Previous Clinical Trials
3,863 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I weigh less than 40 kg.I have severe blockage in my stomach causing vomiting.I haven't had serious heart issues like a heart attack or unstable angina in the last 6 months.I haven't taken any experimental drugs or cancer treatments within the last 21 days.I am a man who will use birth control during and for 6 months after treatment.I have an infection needing treatment that hasn't cleared in the last week.My tumor tested positive for CLDN18.2.I need treatment for another type of cancer.I have cancer in my stomach or where my esophagus meets my stomach.I have a history of lung disease involving the tissue and space around the air sacs.I have an active hepatitis B or C infection.I will not donate eggs during and for 6 months after the study.I will not donate sperm during or for 6 months after the study.I have not taken any systemic immunosuppressive drugs or steroids in the last 14 days.I will not have unprotected sex if my partner is pregnant or breastfeeding during the study and for 6 months after.I have not taken any herbal medications with cancer-fighting properties in the last 28 days.I am fully active or restricted in physically strenuous activity but can do light work.I am legally an adult and can sign the consent form.I do not have significant gastric bleeding or untreated ulcers.I had radiotherapy for advanced stomach or pancreatic cancer and still have side effects.I have an autoimmune disease treated with drugs that weaken my immune system in the last month.I am not pregnant, confirmed by a blood test and doctor's evaluation.I had major surgery less than 28 days ago and haven't fully recovered.I have brain metastases that are causing symptoms or are unstable.I have been diagnosed with pancreatic cancer.My advanced cancer was confirmed by scans within the last 28 days.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Escalation (Phase 1)
- Group 2: Dose Expansion (Phase 1b) Gastric/GEJ cancer
- Group 3: Dose Expansion (Phase 1b) Pancreatic cancer
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the chief aim of this trial?
"The principal endpoint of this 28-day trial is to gauge the incidences of serious adverse events (SAEs). Secondary outcomes include disease control rate according to RECIST 1.1, pharmacokinetics (PK) parameters such as area under the concentration-time curve and time of maximum serum concentrations."
Answered by AI
What is the current participant enrollment rate for this clinical research study?
"Affirmative, the facts on clinicaltrials.gov demonstrate that this medical trial is actively inviting participants. It was first posted on June 7th 2022 and has been recently refreshed on November 15th 2022. The research necessitates 240 individuals across one location to be recruited."
Answered by AI
Is enrollment for this experimental protocol currently open?
"According to the up-to-date information on clinicaltrials.gov, this research is currently accepting candidates; it was first advertised on June 7th 2022 and last revised November 15th 2022."
Answered by AI
To what extent does Dose Escalation (Phase 1) pose a risk to human subjects?
"Due to the limited data on efficacy and safety, our team's score of Dose Escalation (Phase 1) was a 1."
Answered by AI
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