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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 weeks
Treatment ~ Varies
Follow Up ~1-3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-3 years for reporting.

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 more

Trial 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.

Find a Location

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
88,791 Total Patients Enrolled

Media Library

ES002023 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05075564 — Phase 1
Solid Tumors Clinical Trial 2023: ES002023 Highlights & Side Effects. Trial Name: NCT05075564 — Phase 1
ES002023 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05075564 — Phase 1
Solid Tumors Research Study Groups: Part 1 dose escalation, Part 2 dose expansion

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What risks could be associated with Part 1 ES002023?

"Due to its Phase 1 status, limited data supports the safety and efficacy of Part 1 ES002023. Thus, our analysts at Power assigned it a score of 1 on their scale."

Answered by AI

What kind of results is the medical research team hoping to achieve?

"Per the sponsor of this investigation, Elpiscience Biopharma Ltd., the primary outcomes that will be assessed over a 1-3 year period is The frequency and severity of adverse events related to ES002023. In addition, secondary endpoints such as The immunogenicity of ES002023 (assessed by detecting anti-drug antibodies), Trough observed serum concentration (Ctrough)of ES002023, and The antitumor activity of ES002023 (measured via revised Response Evaluation Criteria in Solid Tumors version 1.1 [RECISTv1.1] assessments conducted by investigators"

Answered by AI

How many sites are conducting this research project?

"Currently, 7 sites across the United States are recruiting for this medical trial. Patients may find Fayetteville, Austin and New Brunswick as well as other nearby locations convenient when considering participation in order to limit travel time."

Answered by AI

Is recruitment still ongoing for this research project?

"According to clinicaltrials.gov, this particular trial has finished recruiting participants and is no longer seeking new enrollees. Initially posted on December 23rd 2021, it was last updated October 18th 2022. However, there are presently an additional 2503 studies actively enrolling patients at the moment."

Answered by AI
~18 spots leftby Apr 2025