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Monoclonal Antibodies
Anti-CD39 Antibody for Solid Tumors
Phase 1
Waitlist Available
Research Sponsored by Elpiscience Biopharma, Ltd.
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 1-3 years
Awards & highlights
Study Summary
This trial is testing a new drug for safety and how well it works in patients with cancer that has returned or not responded to other treatments.
Eligible Conditions
- Advanced Solid Tumors
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1-3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The Maximum Tolerated Dose (MTD), Optimal Biological Dose (OBD) and/or the Recommended Phase 2 Dose (RP2D) of ES002023
The frequency and severity of adverse events of ES002023
Secondary outcome measures
Area under the serum concentration time curve (AUC) of ES002023
Maximum observed serum concentration (Cmax) of ES002023
The antitumor activity of ES002023
+6 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Part 2 dose expansionExperimental Treatment1 Intervention
Part 2 of the study will consist of 3 expansion cohorts for pancreatic ductal adenocarcinoma (Cohort 2A), NSCLC (Cohort 2B), and colorectal adenocarcinoma (Cohort 2C) with 10 subjects per expansion cohort respectively at the recommended optimal biological dose determined in Part 1 dose escalation.
Group II: Part 1 dose escalationExperimental Treatment1 Intervention
ES002023 doses will be escalated in patients with advanced solid tumors with approximately 30 subjects.
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Who is running the clinical trial?
Elpiscience Biopharma, Ltd.Lead Sponsor
5 Previous Clinical Trials
122 Total Patients Enrolled
Clinical DevelopmentStudy DirectorElpiscience Biopharma, Ltd.
35 Previous Clinical Trials
88,855 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a history or signs of heart problems.You are allergic to ES002023 or antibodies made from CHO (Chinese hamster ovary) cells.You are expected to live for at least 12 more weeks.You have undergone allergen desensitization therapy in the past month.You have or have had a lung disease called interstitial lung disease (ILD) or pneumonitis that needed treatment with steroids or other medicines that weaken the immune system.You have a liver or bile duct disease that is currently causing problems, except if you have Gilbert's syndrome or asymptomatic gallstones.You have advanced or spreading tumors that cannot be surgically removed. You have already tried standard treatments that didn't work or caused too many side effects.
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.
Research Study Groups:
This trial has the following groups:- Group 1: Part 1 dose escalation
- Group 2: Part 2 dose expansion
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