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PRO1184 for Cancer (PRO1184-001 Trial)

Phase 1 & 2

Recruiting

Research Sponsored by ProfoundBio US Co.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically or cytologically confirmed metastatic or unresectable solid malignancy including ovarian cancer (must have epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer), endometrial cancer, non-small cell lung cancer, breast cancer (hormone receptor positive, HER2-negative and triple-negative), mesothelioma

ECOG performance status 0 or 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 2 years.

Awards & highlights

PRO1184-001 Trial Summary

This trial will test the safety, side effects and effectiveness of a new drug (PRO1184) to treat solid tumor cancers.

Who is the study for?

This trial is for adults with certain advanced solid tumors, including specific types of ovarian, endometrial, lung, and breast cancers or mesothelioma that have spread (metastatic) or can't be removed by surgery. Participants must have measurable disease, adequate organ function, an ECOG performance status of 0 or 1 (which means they are fully active or restricted in physically strenuous activity but ambulatory), and agree to provide a tumor sample.Check my eligibility

What is being tested?

The study tests PRO1184's safety and optimal dosing in part A; part B assesses its effectiveness at the determined dose/schedule. It targets patients whose cancer has either metastasized or is unresectable. The drug's characteristics will be evaluated through participants' responses.See study design

What are the potential side effects?

While the exact side effects of PRO1184 aren't listed here, common ones for cancer drugs include fatigue, nausea, diarrhea, blood count changes increasing infection risk; liver/kidney function alterations; potential allergic reactions; and possibly others as identified during the trial.

PRO1184-001 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My cancer is confirmed and cannot be removed by surgery.

Select...

I am fully active or can carry out light work.

PRO1184-001 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 2 years.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 2 years.

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 2 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

Dose limiting toxicity

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Secondary outcome measures

Area under the plasma concentration versus time curve (AUC) for PRO1184

Best Overall Response

Disease control rate

+5 more

Other outcome measures

Immunogenic potential of PRO1184

PRO1184-001 Trial Design

1Treatment groups

Experimental Treatment

Group I: PRO1184Experimental Treatment1 Intervention

PRO1184 monotherapy in escalating doses in Part A and at the recommended dose in Part B.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

ProfoundBio US Co.Lead Sponsor

2 Previous Clinical Trials

348 Total Patients Enrolled

Media Library

PRO1184 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05579366 — Phase 1 & 2

Breast Cancer Research Study Groups: PRO1184

Breast Cancer Clinical Trial 2023: PRO1184 Highlights & Side Effects. Trial Name: NCT05579366 — Phase 1 & 2

PRO1184 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05579366 — Phase 1 & 2

Frequently Asked Questions

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

Are there any openings to join this clinical experiment at the moment?

"As per the information on clinicaltrials.gov, this study is currently accepting participants. The trial was initially published on November 28th 2022 and has since been updated as recently as the 18th of November 2022."

Answered by AI

What is the scope of participants in this research endeavor?

"In order to fulfil the study's requirements, ProfoundBio US Co. needs 134 individuals who meet all of its inclusion criteria. Participating sites include HonorHealth in Scottsdale, Arizona and University of Oklahoma - Health Sciences Center in Oklahoma City, Oklahoma."

Answered by AI

Are there multiple medical centers participating in this research study within the city's limits?

"This trial is being conducted across a variety of sites including HonorHealth in Scottsdale, Arizona, University of Oklahoma - Health Sciences Center in Oklahoma City, Oklahoma and Sarah Cannon Research Institute at Tennessee Oncology in Nashville, Tennessee among other 10 locations."

Answered by AI

What end-result is this clinical trial attempting to achieve?

"According to the study sponsor, ProfoundBio US Co., Dose Limiting Toxicity (DLT) will be monitored as the primary outcome throughout this trial period of up to one year. Additional secondary outcomes such as Best Overall Response (RECIST v1.1 for all tumor types except pleural mesothelioma), Disease Control Rate and Area Under Curve in Plasma Concentration Versus Time graph for PRO1184will also be observed."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

PRO1184 for Advanced Solid Tumors

2022. "PRO1184 for Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05579366.

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