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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 2 years
Awards & highlights
Study Summary
This trial will study the safety and effectiveness of a new drug in adults. It will determine the best dose to use.
Who is the study for?
Adults over 18 with certain solid tumors (like colorectal, lung, pancreatic cancers) who've tried all standard treatments or can't have them. They must be relatively healthy (ECOG 0-1), have a life expectancy over 3 months, and not be pregnant or breastfeeding. Excluded are those with active infections, lung disease, hepatitis B/C, HIV, autoimmune disorders needing steroids/immunosuppressants, recent major surgery or vaccine; also if they're on other trials.Check my eligibility
What is being tested?
The trial is testing AMG 305's safety and what dose works best without being too much for people with advanced solid tumors. It aims to find the highest dose patients can take without serious side effects (MTD) and decide the right amount for future studies (RP2D).See study design
What are the potential side effects?
While specific side effects of AMG 305 aren't listed here, common ones in cancer drug trials include nausea, fatigue, risk of infection due to immune system impact; organ inflammation; allergic reactions; blood clots or bleeding issues.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of Participants who Experience Dose Limiting Toxicities (DLTs)
Percentage of Participants who Experience Treatment-Emergent Adverse Events (TEAEs)
Percentage of Participants who Experience Treatment-Related Adverse Events
Secondary outcome measures
Area Under the Concentration-Time Curve (AUC) of AMG 305
Duration of Response (DOR)
Maximum Serum Concentration (Cmax) of AMG 305
+7 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Part B: Dose ExpansionExperimental Treatment1 Intervention
Participants with non-small cell lung cancer (NSCLC), colorectal cancer (CRC), pancreatic cancer, and other solid tumors will receive the RP2D identified in Part A.
Group II: Part A: Dose ExplorationExperimental Treatment1 Intervention
Participants will receive escalating doses of AMG 305.
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Who is running the clinical trial?
AmgenLead Sponsor
1,371 Previous Clinical Trials
1,377,958 Total Patients Enrolled
MDStudy DirectorAmgen
915 Previous Clinical Trials
924,470 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not received any live vaccines in the last 28 days or more.I have had cancer other than my current diagnosis in the last 2 years.I have a solid tumor cancer and have tried all standard treatments or cannot undergo them.I frequently need procedures to remove excess fluid from my chest or abdomen.I have been diagnosed with interstitial lung disease.I am not on steroids or immunosuppressants for conditions like Crohn's disease.I have brain metastases or spinal issues related to my cancer that haven't been treated.I currently have an infection.I have not had major surgery in the last 4 weeks.My organs are working well.I am 18 years old or older.I haven't had cancer treatments, except for pain relief, in the last 4 weeks or longer.I am not pregnant, breastfeeding, nor planning to become pregnant during the study.My cancer expresses cadherin-3 and mesothelin.I am fully active or can carry out light work.I am willing to use birth control as specified by the study.I have a tumor larger than 10 mm that hasn't been biopsied in the last 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: Part A: Dose Exploration
- Group 2: Part B: Dose Expansion
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.
Is there an opportunity to participate in this research project?
"Applicants must possess solid tumours and be aged between 18-100 in order to qualify for this trial. Currently, the team is enrolling a total of 260 participants."
Answered by AI
What potential harms are associated with Part A: Dose Exploration?
"The team's assessment of Part A: Dose Exploration yielded a score of 1, due to the limited evidence that supports its safety and efficacy as this is only a Phase 1 trial."
Answered by AI
How many participants are signing up for the experiment?
"To conduct this trial, Amgen seeks a total of 260 eligible participants. The pharmaceutical giant will be running the research from two sites: Next Oncology in San Antonio (TX) and Peter MacCallum Cancer Centre in Melbourne (VIC)."
Answered by AI
Is the trial taking into consideration participants who are greater than eighty-five years of age?
"The prerequisites for being included in this trial dictate that participants must be 18 to 100 years old. Separately, there are 315 clinical trials open to minors and 2442 available for senior citizens."
Answered by AI
Are individuals still able to join this investigation?
"Affirmative. Evidence found on clinicaltrials.gov confirms that this study is actively enrolling participants, which it has been doing since June 13th 2023. Three medical centres are needed for the recruitment of 260 patients."
Answered by AI
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