ProAgio for Pancreatic Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Pancreatic Cancer+1 MoreProAgio - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new cancer drug to see if it is safe for people with advanced pancreatic cancer.

Eligible Conditions
  • Pancreatic Cancer
  • Solid Tumor Cancers

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 9 Secondary · Reporting Duration: 3 Years

3 Years
Determine Recommended Phase 2 Dose (RP2D)
Evaluate the Maximum Plasma Concentration of ProAgio
Evaluate the Serum half-life of ProAgio
Evaluate the area under the curve of ProAgio
Evaluate the volume of distribution of ProAgio
Objective Response Rate (ORR)
Rate of study drug elimination in research participants
Safety and Tolerability of ProAgio
At 18 Weeks
Disease control rate (DCR).
Day 30
Assess serum tumor marker CA19-9 or appropriate tumor specific marker.

Trial Safety

Safety Progress

1 of 3

Trial Design

3 Treatment Groups

Standard Arm
1 of 3
Dose Escalation
1 of 3
Biopsy Arm
1 of 3

Experimental Treatment

58 Total Participants · 3 Treatment Groups

Primary Treatment: ProAgio · No Placebo Group · Phase 1

Standard Arm
Drug
Experimental Group · 1 Intervention: ProAgio · Intervention Types: Drug
Dose Escalation
Drug
Experimental Group · 1 Intervention: ProAgio · Intervention Types: Drug
Biopsy Arm
Drug
Experimental Group · 1 Intervention: ProAgio · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 3 years

Who is running the clinical trial?

ProDa BioTech, LLCLead Sponsor
National Cancer Institute (NCI)NIH
13,068 Previous Clinical Trials
41,129,278 Total Patients Enrolled
Christine Alewine, MD, PhDPrincipal InvestigatorNational Cancer Institute (NCI)

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Participants in the expansion cohort must have measurable disease, per RECIST 1.1.1.1.1.1.
Children are excluded from this study.
You have an absolute neutrophil count of at least 1,000/mm.