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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.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for solid tumors include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy works by killing rapidly dividing cells, which includes cancer cells, but also affects normal cells, leading to side effects.
Targeted therapy aims at specific molecules involved in cancer growth and survival, such as tyrosine kinases or hormone receptors, offering a more precise approach with potentially fewer side effects. Immunotherapy leverages the body's immune system to recognize and destroy cancer cells, often by inhibiting checkpoints that prevent immune activation.
These mechanisms are crucial for solid tumor patients as they provide multiple avenues to attack the cancer, potentially improving outcomes and offering options when tumors become resistant to one type of treatment. Treatments like AMG 305, though not specified, likely fall into one of these categories, aiming to enhance efficacy and reduce toxicity in managing advanced solid tumors.
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Who is running the clinical trial?
AmgenLead Sponsor
1,384 Previous Clinical Trials
1,379,891 Total Patients Enrolled
MDStudy DirectorAmgen
930 Previous Clinical Trials
926,938 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.
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