Your session is about to expire
← Back to Search
Other
EBC-129 + Pembrolizumab for Advanced Cancer
Phase 1
Recruiting
Research Sponsored by EDDC (Experimental Drug Development Centre), A*STAR Research Entities
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 approximately 3.3 years
Awards & highlights
Study Summary
This trial tests a new drug to treat advanced cancer, and its safety when combined with another existing cancer drug.
Who is the study for?
Adults with advanced solid tumors that have grown despite no available treatments or intolerance to them can join. They must be over 18 (USA) or 21 (Singapore), weigh between 40-100 kg, and have a performance status of ≤2. Participants need proper bone marrow, liver, and kidney function but cannot join if they've had recent cancer therapy, severe allergies to E coli-derived products, active brain metastases, certain infections like HIV/Hepatitis B/C, autoimmune diseases treated within the last two years, are pregnant/breastfeeding or have specific eye conditions.Check my eligibility
What is being tested?
The trial is testing EBC-129 alone and combined with pembrolizumab for safety in treating advanced solid tumors. It will see how patients tolerate these drugs and look for any signs of effectiveness against the tumors.See study design
What are the potential side effects?
Possible side effects include reactions related to immune system activation such as inflammation in various organs which could lead to symptoms like fatigue or digestive issues; allergic reactions; blood disorders; increased risk of infection; potential eye problems when using pembrolizumab.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 3.3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 3.3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Part A and Part B- Determination of Maximum tolerated dose (MTD)
Part A and Part B- Determination of the Recommended Phase 2 dose (RP2D)
Part A, Part B and Part C- Number of patients with serious adverse events (SAEs) and treatment emergent adverse events (TEAEs)
+1 moreSecondary outcome measures
Part A and Part B- ORR
Part A, Part B and Part C- Accumulation ratios
Part A, Part B and Part C- Area under the curve at steady state (AUC0-21d_ss)
+20 moreTrial Design
7Treatment groups
Experimental Treatment
Group I: Part CExperimental Treatment1 Intervention
Patients will be administered the highest dose of EBC-129 as a monotherapy at the RP2D determined in Part A of the study.
Group II: Part BExperimental Treatment2 Interventions
Patients will be administered three different dose levels of EBC-129 in combination with a fixed dose of pembrolizumab.
Group III: Part A-Cohort 5Experimental Treatment1 Intervention
Patients will be administered Dose 5 of EBC-129 as a monotherapy.
Group IV: Part A-Cohort 4Experimental Treatment1 Intervention
Patients will be administered Dose 4 of EBC-129 as a monotherapy.
Group V: Part A-Cohort 3Experimental Treatment1 Intervention
Patients will be administered Dose 3 of EBC-129 as a monotherapy.
Group VI: Part A-Cohort 2Experimental Treatment1 Intervention
Patients will be administered Dose 2 of EBC-129 as a monotherapy.
Group VII: Part A-Cohort 1Experimental Treatment1 Intervention
Patients will be administered Dose 1 of EBC-129 as a monotherapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
EDDC (Experimental Drug Development Centre), A*STAR Research EntitiesLead Sponsor
2 Previous Clinical Trials
89 Total Patients Enrolled
ParexelIndustry Sponsor
304 Previous Clinical Trials
101,068 Total Patients Enrolled
Venkateshan Srirangam Prativadibhayankara, MDStudy DirectorEDDC (Experimental Drug Development Centre), A*STAR Research Entities
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have active brain tumors from cancer spread.I have undergone radiation therapy before.I have received drugs to boost my blood cells within the last 4 weeks.I haven't taken any strong medication that affects drug processing in the body for the last 14 days.I am currently not on any cancer treatments.I am severely allergic to E. coli products or had a bad reaction to filgrastim or peg-filgrastim.I haven't taken any experimental or cancer treatments in the last 4 weeks.I had a severe reaction to immune therapy that hasn't fully improved or still needs high-dose steroids.I do not have ongoing eye conditions that need treatment or any significant corneal disease.I do not have an active infection like HIV, Hepatitis B, or C.My bone marrow is working well.My weight is between 40 kg and 100 kg.My cancer has spread, cannot be surgically removed, and I can't use or have used all standard treatments without success.I can take care of myself but might not be able to do heavy physical work.My liver and kidneys are working well.I cannot or do not want to provide a tumor tissue sample unless biopsy poses a significant risk to me.I have an autoimmune disease treated in the last 2 years.I haven't had major surgery in the last 4 weeks.I am at least 18 years old in the USA or 21 in Singapore.I have not had lung inflammation, recent live vaccines, or stopped immune therapy due to heart issues.
Research Study Groups:
This trial has the following groups:- Group 1: Part A-Cohort 1
- Group 2: Part A-Cohort 2
- Group 3: Part A-Cohort 3
- Group 4: Part A-Cohort 4
- Group 5: Part A-Cohort 5
- Group 6: Part B
- Group 7: Part C
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.
Are there any opportunities for participants to join this medical study presently?
"This investigation, initially posted on April 18th 2023, is not presently recruiting participants. Despite that fact, there are close to 2500 other medical studies actively looking for volunteers as of now."
Answered by AI
Are there any potential risks associated with Part A-Cohort 1?
"Our experts at Power gave Part A-Cohort 1 a score of one since this is only the first clinical trial. Thus, there is not enough evidence to guarantee its safety and efficacy yet."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger