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ASP1002 for Cancer
Phase 1
Waitlist Available
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 28 months
Awards & highlights
Study Summary
This trial studies a new treatment (ASP1002) for people with certain solid tumors. It aims to learn if it has any medical problems or side effects and to find a suitable dose to use in future studies. People will receive infusions & checks during visits over 2 years.
Who is the study for?
Adults with advanced solid tumors and high claudin 4 levels, who've tried standard treatments or refused them, can join. They must be fairly active (ECOG Status of 0 or 1), expected to live at least 12 weeks, have good organ function, and a measurable tumor. Pregnant women can't join; participants must agree to contraception.Check my eligibility
What is being tested?
ASP1002 is being tested in two parts: first to find safe doses by giving it through an IV in increasing amounts to small groups. Then the best doses are used on different groups for up to two years or until side effects become too severe.See study design
What are the potential side effects?
Potential side effects include reactions related to infusion, fatigue, changes in blood tests reflecting organ functions, and possibly other symptoms that could lead participants to stop treatment if they become serious.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 28 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 28 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) for ASP1002
Number of participants at each grade of Eastern Cooperative Oncology Group (ECOG) performance status scores
Number of participants with Adverse Events (AEs)
+5 moreSecondary outcome measures
Changes in expression levels of Claudin-4 (CLDN4) by immunohistochemistry (IHC)
Disease Control Rate (DCR) per RECIST v1.1
Disease Control Rate (DCR) per iRECIST
+9 moreTrial Design
4Treatment groups
Experimental Treatment
Group I: Experimental: ASP1002 Dose Expansion (Part 2) colorectal cancer (CRC)Experimental Treatment1 Intervention
Participants will receive ASP1002 with dose/regimen selected from dose escalation (Part 1).
Group II: Experimental: AS1002 Dose Expansion (Part 2) urothelial carcinoma (UC)Experimental Treatment1 Intervention
Participants will receive ASP1002 with dose/regimen selected from dose escalation (Part 1).
Group III: ASP1002 Dose Expansion (Part 2) non-small cell lung cancer (NSCLC)Experimental Treatment1 Intervention
Participants will receive ASP1002 with dose/regimen selected from dose escalation (Part 1).
Group IV: ASP1002 Dose Escalation (Part 1)Experimental Treatment1 Intervention
Participants will be assigned to sequentially escalating doses of ASP1002. Each dose level will open sequentially 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
120,852 Total Patients Enrolled
Medical DirectorStudy DirectorAstellas Pharma Global Development, Inc.
2,777 Previous Clinical Trials
8,063,654 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have recent tumor tissue samples available.I have not had major surgery in the last 28 days.My cancer is advanced and cannot be removed by surgery.I have untreated brain metastases.I will not donate eggs during the trial.I have received specific treatments recently.I have not taken steroids or immunosuppressants within the last 14 days.My cancer type is one of the following: NSCLC, urothelial, colorectal, prostate, ovarian, or triple-negative breast.I have had a bone marrow or organ transplant from another person.My condition worsened or I can't tolerate/accept standard treatments.I have not received a live vaccine in the last 28 days.I weigh less than 40 kg.I will need additional cancer treatment while on this study.I stopped my previous immune therapy because of severe side effects.I have needed IV antibiotics for an infection within the last 14 days.I agree not to breastfeed during the trial.I will not donate sperm during the trial.I am fully active or restricted in physically strenuous activity but can do light work.I have a history of lung conditions.I am currently being treated for another type of cancer.I have previously received anti-CD137 therapy.My organs are functioning well enough to start treatment.I will use birth control if my partner is pregnant.I am experiencing significant side effects from previous cancer treatments.I am a man and will use birth control with my partner who can have children.I finished my radiotherapy at least 2 weeks ago.I have had heart problems within a specific time.I am not pregnant and follow the required contraceptive guidelines.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental: AS1002 Dose Expansion (Part 2) urothelial carcinoma (UC)
- Group 2: Experimental: ASP1002 Dose Expansion (Part 2) colorectal cancer (CRC)
- Group 3: ASP1002 Dose Escalation (Part 1)
- Group 4: ASP1002 Dose Expansion (Part 2) non-small cell lung cancer (NSCLC)
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 possible harmful effects could result from administering ASP1002 Dose Escalation (Part 1) to patients?
"Due to the preliminary state of clinical research, our team at Power assigned ASP1002 Dose Escalation (Part 1) a score of one in terms of safety. This is because Phase 1 trials provide limited evidence regarding both efficacy and risk profiles."
Answered by AI
How many individuals have elected to participate in this trial?
"Affirmative. According to information available on clinicaltrials.gov, this trial is actively recruiting patients since its posting date of February 21st 2023 and was last updated on March 7th 2023. 210 individuals need to be enrolled across two medical locations."
Answered by AI
Is it still possible for individuals to join this clinical experiment?
"Per the clinicaltrials.gov website, this experiment is currently recruiting volunteers and has been receiving updates since its initiation on February 21st 2023. The most recent edit was made on March 7th of the same year."
Answered by AI
What are the desired outcomes for this medical experiment?
"The sponsor of this medical trial, Astellas Pharma Global Development Inc., has outlined the primary outcome as Adverse Events (AEs) and physical exam abnormalities over a 24 month period. Secondary outcomes span from Maximum concentration (Cmax), Duration of Response (DOR), to Disease Control Rate (DCR)."
Answered by AI
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