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ERAS-007 Combination Therapy for Gastrointestinal Cancer (HERKULES-3 Trial)
HERKULES-3 Trial Summary
This trial is testing a new cancer drug to see if it is safe and works well with other cancer treatments. They will also look at how the body processes the drug.
HERKULES-3 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowHERKULES-3 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.HERKULES-3 Trial Design
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Who is running the clinical trial?
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- I have not had major surgery in the last 28 days and do not plan to during the study.I have a serious lung condition that is not under control.My organs and bone marrow are working well.I am fully active or restricted in physically strenuous activity but can do light work.I am 18 years old or older.I have a stomach or intestine condition that affects how I absorb pills.I do not have any severe illnesses that would prevent me from joining the study.I received palliative radiation within the last week before starting the study drug.My colorectal or pancreatic cancer has specific genetic mutations.I can take pills by mouth.I do not have an active infection needing treatment or a history of HIV, hepatitis B, or C.I have previously been treated with a RAS, MEK, or ERK inhibitor.I have not had a blood clot or stroke in the last 6 months.I have brain metastasis or leptomeningeal disease causing symptoms.I have heart problems or significant heart disease.I am allergic or cannot take encorafenib, cetuximab, or palbociclib due to health reasons.I have not needed treatment for inflammatory bowel disease or Crohn's in the last year.I haven't had cancer treatment in the last 3 weeks or within 4 half-lives of the treatment, whichever is shorter.
- Group 1: Dose Expan (Parts A1b, A1c, A2b, A2c, A3b, or A3c): ERAS-007 in combo with encorafenib & cetuximab
- Group 2: Dose Expansion (Parts B1b, B2b, B3b, and B4b): ERAS-007 in combination with palbociclib
- Group 3: Dose Escalation (Parts A1a, A2a, or A3a): ERAS-007 in combination with encorafenib and cetuximab
- Group 4: Dose Escalation (Parts B1a, B2a, B3a or B4a): ERAS-007 in combination with palbociclib
- 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
Is there an age restriction for participation in this medical experiment?
"As outlined in the enrollment requirements, individuals must be 18 or older and under 99 to participate."
What aims does this experiment endeavor to accomplish?
"The main objective of this trial, taking place over a duration of 29 days from the start date, is to determine Recommended Dose (RD). Auxiliary objectives include assessing Plasma Concentration (Cmax), Time to achieve Cmax (Tmax) and Objective Response Rate (ORR) based on RECIST version 1.1 imaging evaluations."
Is enrollment in this experiment still available to participants?
"According to clinicaltrials.gov, this research is actively soliciting applicants and has been operational since September 20th 2021 with the latest update on May 26th 2022."
Who is eligible to participate in the research project?
"This clinical trial is recruiting 200 individuals with colorectal cancer, between the ages of 18 and 99. The additional inclusion criteria demand that potential participants have a ECOG performance status 0 or 1 and measurable disease per RECIST v1.1 guidelines. Furthermore, patients must be willing to comply with all protocol-required visits, assessments, and procedures for this study."
How many locations are currently executing this research endeavor?
"The University of California Irvine College of Medicine, UCSF Mount Zion Medical Ctr, North carolina and Duke Cancer Institute in Durham Massachusetts are just 4 locations that are conducting this clinical trial. An additional 15 sites have also been listed as participants."
How many participants have been recruited for this medical experiment?
"To successfully complete this clinical trial, 200 suitable patients must be enrolled. Potential participants can apply to either the University of California Irvine College of Medicine in Orange or UCSF Mount Zion Medical Ctr in San Francisco."
Has the experimental drug ERAS-007 been put to test in any other experiments?
"Currently, 277 trials researching ERAS-007 are in operation, with 47 of them being staged at the Phase 3 level. While Dresden, Arizona is home to many studies for this treatment, a total of 13507 locations across the globe are hosting research initiatives surrounding it."
What afflictions are ameliorated by the utilization of ERAS-007?
"ERAS-007 is a common prescription for radiation therapy and can also provide relief from metastatic melanoma, hnscc, and unresectable melanoma."
Who else is applying?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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