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Study Summary
This trial is testing a new cancer drug, ASP3082, to see if it is safe and effective in treating people with certain solid tumors.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2013 Phase 2 trial • 86 Patients • NCT01256385Trial Design
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Who is running the clinical trial?
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- I have brain metastases but they are either symptom-free or treated.I agree to provide recent or archived tumor samples for the study.I will need additional cancer treatment while on the study.I haven't needed treatment for another cancer in the last 2 years, except for certain skin, bladder, cervix, or breast conditions.I have not had a heart attack or severe heart issues in the last 6 months.I will not donate eggs during and for 6 months after the study.I finished any radiotherapy 14 days ago, have no side effects, and don't need steroids.I am a man and will use birth control during and for 3 months after treatment if my partner can have children.I will not have unprotected sex if my partner is pregnant during the study and for 3 months after.My cancer has a specific KRAS G12D mutation and I've tried all standard treatments without success or can't continue them.It's been over 21 days or 5 half-lives since my last cancer treatment before starting the study.I am not pregnant, confirmed by tests and doctor's evaluation.My organ function meets the required levels for the study.I have been treated with a KRAS G12D inhibitor for my cancer.I have had an infection that needed IV antibiotics in the last 2 weeks.I have not had major surgery in the last 4 weeks.I agree not to breastfeed during and for 6 months after the study.My side effects from previous treatments, except for hair loss, have mostly gone away.I am considering ASP3082 combination therapy for colorectal cancer.My cancer has spread to the lining of my brain and spinal cord.I will not donate sperm during or for 3 months after the study.I had to stop taking cetuximab because it was causing me severe side effects.I can care for myself and am up and about more than 50% of my waking hours.I have had lung disease treated with steroids but am now recovered.I have active hepatitis B or C.I have a solid tumor for the trial, or PDAC with ≤2 prior therapies, or CRC for combination therapy.I have at least one tumor that can be measured by medical imaging.
- Group 1: ASP3082 Dose Escalation (Monotherapy Part 1)
- Group 2: ASP3082 Dose Expansion (Monotherapy Part 2)
- Group 3: ASP3082 + Cetuximab Dose Escalation (Combination Therapy Part 1)
- Group 4: ASP3082 + Cetuximab Dose Expansion (Combination Therapy Part 2)
- Group 5: ASP3082 China Safety Cohort
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
What is the overall size of this trial's participant pool?
"To complete this research, 240 qualified individuals have to be recruited from around the country. Specifically, patients can join in at Vanderbilt University Medical Center and Washington University School of Medicine."
What sort of results is this experiment aiming to accomplish?
"The primary outcome for this medical trial, which is conducted by Astellas Pharma Inc. and will endure up to 48 months, will be the number of participants that experience laboratory value abnormalities or adverse events (AEs). Secondary outcomes include tmax from plasma samples collected as part of pharmacokinetics (PK), disease control rate per RECIST version 1.1 and AUC based on PK plasma sample data collection."
Where can one find a medical facility that is participating in the trial within this city?
"11 medical centres are currently enrolling patients in this clinical trial. Notable locations include Vanderbilt University Medical Center (Nashville), Washington University School of Medicine (Saint Louis) and Florida Cancer Specialists & Research Institute Sarasota (Sarasota)."
Has the FDA passed judgement on ASP3082?
"Because of its limited clinical data, ASP3082 received a score of 1 on our safety scale. This trial is currently in Phase 1 and does not yet have sufficient evidence to support efficacy or safety."
Is there an ongoing call for participants in this experiment?
"According to the information found on clinicaltrials.gov, this experiment is still recruiting participants. It was first posted on June 8th 2022 and its data has been revised most recently on November 17th of the same year."
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