PRO1184 for erbB-2 Receptor

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
erbB-2 Receptor+18 More
PRO1184 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This study will test the safety, including side effects, and determine the characteristics of a drug called PRO1184 in participants with solid tumors. Participants will have solid tumor cancer that has spread through the body (metastatic) or cannot be removed with surgery (unresectable). This study will have two parts. Part A of the study will find out how much and how frequently PRO1184 should be given to participants. Part B will use the dose and schedule found in Part A to find out how safe PRO1184 is and if it works to treat solid tumor cancers.

Eligible Conditions
  • Ovarian Cancer
  • Endometrial Cancer
  • erbB-2 Receptor
  • Primary Peritoneal Carcinoma
  • Breast Cancer (Triple Negative Breast Cancer (TNBC))
  • Hormone Receptor-positive Breast Cancer
  • Fallopian Tubes Cancer
  • Non-small Cell Lung Cancer
  • Mesothelioma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

Study Objectives

2 Primary · 8 Secondary · Reporting Duration: Up to approximately 2 years.

Day 21
Dose limiting toxicity
Month 12
Duration of objective response
Year 1
Area under the plasma concentration versus time curve (AUC) for PRO1184
Immunogenic potential of PRO1184
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Peak Plasma Concentration (Cmax) for PRO1184
Year 1
Best Overall Response
Disease control rate
Objective response rate
Month 18
Progression-free survival
Year 2
Overall survival

Trial Safety

Safety Progress

1 of 3

Similar Trials

Trial Design

1 Treatment Group

PRO1184
1 of 1

Experimental Treatment

134 Total Participants · 1 Treatment Group

Primary Treatment: PRO1184 · No Placebo Group · Phase 1 & 2

PRO1184
Drug
Experimental Group · 1 Intervention: PRO1184 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to approximately 2 years.

Who is running the clinical trial?

ProfoundBio US Co.Lead Sponsor

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a performance status of 0 or 1.
You are willing to provide a tumor sample (archive tissue or fresh biopsy).
You have measurable disease per RECIST v1.
The presence of folate receptor alpha expression in tumor cells is evidence of a poor prognosis in patients with ovarian cancer.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 20th, 2021

Last Reviewed: November 6th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.