PRL3-zumab for Solid Tumors

Norton Healthcare, Louisville, KY
Solid TumorsPRL3-zumab - Biological
Eligibility
18+
All Sexes

Study Summary

This trial is testing a new drug for cancer that has not been treated before. It is open to people with cancer that has spread or cannot be removed by surgery.

Eligible Conditions
  • Solid Tumors

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

Study Objectives

6 Primary · 9 Secondary · Reporting Duration: Up to approximately 6 months

From first dose of study drug until disease progression or end of treatment, whichever comes first
Clinical benefit rate (CBR)
Duration of response
Eastern Cooperative Oncology Group Performance Status (ECOG PS)
European Organization for Research and Treatment of Cancer-quality of life quantionnaire-C30 (EORTC-QLQ-C30)
European Quality-5D (EQ-5D)
Number of patients with adverse events and serious adverse events
Objective response rate (ORR)
Overall survival (OS)
Progression free survival (PFS)
Month 6
Time to response
Month 6
Area under the concentration time curve from pre-dose (AUCinf)
Maximum plasma PRL3-zumab concentration (Cmax)
Terminal elimination half life (t½)
Time of Cmax (tmax)
Month 6
Incidence of anti drug antibody (ADA)

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

1 Treatment Group

PRL3-zumab
1 of 1

Experimental Treatment

55 Total Participants · 1 Treatment Group

Primary Treatment: PRL3-zumab · No Placebo Group · Phase 2

PRL3-zumab
Biological
Experimental Group · 1 Intervention: PRL3-zumab · Intervention Types: Biological

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to approximately 6 months

Who is running the clinical trial?

ParexelIndustry Sponsor
286 Previous Clinical Trials
93,678 Total Patients Enrolled
Intra-IMMUSG Pte LtdLead Sponsor

Eligibility Criteria

Age 18+ · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are expected to live for at least 6 more months.