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ASP2074 for Solid Tumors
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 has progressed or failed to tolerate after receiving all standard approved therapies or is no longer eligible for standard therapy (no limit to the number of prior treatment regimens).
Participant has an Eastern Cooperative Oncology Group (ECOG) Status of 0 or 1.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 21 months
Awards & highlights
Study Summary
This trial will study a potential new treatment, ASP2074, for people with certain solid tumors who have already tried standard treatments. They will be given different doses to find the most suitable one, and monitored for any medical problems from the treatment.
Who is the study for?
Adults with advanced solid tumors that have spread and are not responding to standard treatments can join this trial. They must be in good physical condition (ECOG Status of 0 or 1), have recovered from previous therapies, agree to use contraception, and not be pregnant or breastfeeding. Specific cancers like colorectal, pancreatic, gastric cancer, esophageal or GEJ adenocarcinoma are included for certain parts of the study.Check my eligibility
What is being tested?
ASP2074 is being tested as a new treatment for solid tumors. The trial has two parts: first to find safe doses by giving different amounts to small groups and monitoring for problems; second to confirm these doses in more people. It's given as an infusion at the start of each cycle until it's no longer tolerated or effective.See study design
What are the potential side effects?
Potential side effects aren't detailed but will include any medical problems arising from ASP2074 during treatment cycles. These could range from mild reactions at the infusion site to more serious issues affecting organs due to drug toxicity.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My condition worsened or I couldn't handle the side effects after all standard treatments.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My side effects from previous treatments, except for hair loss, have mostly gone away or returned to normal.
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I have an advanced solid tumor or specific types of cancer with no limit on prior treatments.
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My condition worsened or I couldn't handle the side effects after all standard treatments.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
I will not donate eggs during and for 3 months after the study.
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) for ASP2074
Number of participants with Adverse Events (AEs)
Number of participants with Serious Adverse Events (SAEs)
+3 moreSecondary outcome measures
Change from Baseline in Serum CA19-9 levels in participants with pancreatic cancer
Change from Baseline in target antigen expression
Change from Baseline in tumor CD8 infiltration/ activation
+10 moreTrial Design
4Treatment groups
Experimental Treatment
Group I: ASP2074 Dose Expansion (Part 2) Pancreatic AdenocarcinomaExperimental Treatment1 Intervention
Participants will receive ASP2074 with dose/regimen selected from dose escalation (Part 1).
Group II: ASP2074 Dose Expansion (Part 2) Esophageal or GEJ AdenocarcinomaExperimental Treatment1 Intervention
Participants will receive ASP2074 with dose/regimen selected from dose escalation (Part 1).
Group III: ASP2074 Dose Expansion (Part 2) Colorectal AdenocarcinomaExperimental Treatment1 Intervention
Participants will receive ASP2074 with dose/regimen selected from dose escalation (Part 1).
Group IV: ASP2074 Dose Escalation (Part 1)Experimental Treatment1 Intervention
Participants will be assigned to sequentially escalating dose/regimen cohorts of ASP2074 in three parts (Part A, B and C). Part B and Part C will be opened sequentially based upon sponsor review of emerging data.
Find a Location
Who is running the clinical trial?
Astellas Pharma Global Development, Inc.Lead Sponsor
192 Previous Clinical Trials
120,893 Total Patients Enrolled
Senior Medical DirectorStudy DirectorAstellas Pharma Global Development, Inc.
54 Previous Clinical Trials
12,884 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had a stroke or mini-stroke in the last 6 months.I have had major blood vessel problems, like an aneurysm or clot, in the last 6 months.I haven't taken strong immune system suppressing drugs in the last 14 days, except for low-dose steroids or a one-time dose for tests.I have an autoimmune disease but it's either type 1 diabetes, a stable hormone issue, or a skin condition not needing strong medication.I was treated for hepatitis C and now have no detectable virus.I do not have a history of significant heart disease.My high blood pressure is not well-controlled despite taking medication.I have had cancer before, but it's either been treated or was a minor type not needing recent treatment.I have at least one tumor that can be measured.My condition worsened or I couldn't handle the side effects after all standard treatments.I am fully active or restricted in physically strenuous activity but can do light work.I finished any radiotherapy at least 2 weeks before starting the study treatment.My side effects from previous treatments, except for hair loss, have mostly gone away or returned to normal within the last 2 weeks.I will not donate eggs during and for 3 months after the study.I agree not to donate sperm during and for 3 months after the study.I will not have unprotected sex if my partner is pregnant during the study and for 90 days after.I have moderate to severe heart failure.My cancer is either squamous cell colorectal, gastrointestinal stromal, or neuroendocrine.I have an active hepatitis B or C infection.I have had a bone marrow or organ transplant from another person.I had a heart attack or unstable chest pain in the last 6 months.I have not taken medication for an infection in the last 14 days.I have an advanced solid tumor or specific types of cancer with no limit on prior treatments.I have a heart rhythm problem or use a pacemaker.I am a man who will use contraception during and for 3 months after the study.I weigh less than 40 kg.My condition worsened or I couldn't handle the side effects after all standard treatments.I have advanced cancer that cannot be surgically removed or has spread, with a confirmed diagnosis.I am fully active or restricted in physically strenuous activity but can do light work.I finished any radiotherapy at least 2 weeks before starting the study treatment.My side effects from previous treatments, except for hair loss, have mostly gone away or returned to normal.I have at least one tumor that can be measured according to RECIST v1.1.I haven't taken any experimental drugs or used experimental devices within the last 21 days or 5 half-lives, whichever is shorter.I stopped previous immune therapy due to severe side effects.My brain metastases are stable, and I haven't needed high doses of steroids for more than 2 weeks.I am hepatitis B core antibody positive but will be excluded if my hepatitis B virus DNA test is positive.I have had hepatitis C but currently do not have an active infection.I have not received a live vaccine in the last 28 days.I will need additional cancer treatment while on the study.I have or had lung inflammation not caused by an infection.I have not had major surgery in the last 28 days.I am not pregnant, confirmed by a test and doctor's evaluation.I agree not to breastfeed during and for 90 days after the study.
Research Study Groups:
This trial has the following groups:- Group 1: ASP2074 Dose Expansion (Part 2) Colorectal Adenocarcinoma
- Group 2: ASP2074 Dose Expansion (Part 2) Esophageal or GEJ Adenocarcinoma
- Group 3: ASP2074 Dose Escalation (Part 1)
- Group 4: ASP2074 Dose Expansion (Part 2) Pancreatic Adenocarcinoma
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.
Solid Tumors Patient Testimony for trial: Trial Name: NCT05646797 — Phase 1
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is it possible for new participants to register for this research endeavor?
"This research study is currently recruiting patients, as noted on clinicaltrials.gov. It was first posted to the website and last updated in February of 2023."
Answered by AI
To what extent can ASP2074 Dose Escalation (Part 1) be perilous to individuals?
"ASP2074 Dose Escalation (Part 1) has a safety rating of 1, due to the limited data available on its efficacy and level of risk. This is an early-stage trial."
Answered by AI
How many participants have been enrolled in this clinical experiment?
"Affirmative. The records on clinicaltrials.gov verify that this medical trial is presently soliciting participants, which it originally advertised starting January 25th 2023 and adjusted most recently February 20th of the same year. 193 individuals are required to register from a solitary location."
Answered by AI
What is the desired outcome of this experiment?
"This clinical trial intends to measure the number of Adverse Events experienced by participants over a 28-day period, with secondary objectives including an assessment of Objective Response Rates (ORR) according to iRECIST and RECIST v1.1 criteria along with Duration of Response (DOR)."
Answered by AI
Who else is applying?
What state do they live in?
Washington
What site did they apply to?
Virginia Mason Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1
Why did patients apply to this trial?
My husband Gregory had radiatiion in June for Peritoneal Liposarcoma and tumor didn't shrink as planned. Kaiser will not operate so looking for alternative.
PatientReceived 1 prior treatment
What questions have other patients asked about this trial?
The main question would be...is the solid tumor trial applicable for my condition?
PatientReceived 2+ prior treatments
How responsive is this trial?
Average response time
- < 2 Days
Typically responds via
Email
Most responsive sites:
- Virginia Mason Medical Center: < 48 hours
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