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PRO1184 for Cancer (PRO1184-001 Trial)
Phase 1 & 2
Recruiting
Research Sponsored by Genmab
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
Must not have
Other malignancy within 3 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 2 years.
Awards & highlights
No Placebo-Only Group
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.
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.
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is confirmed and cannot be removed by surgery.
Select...
I am fully active or can carry out light work.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have not had any other cancer in the last 3 years.
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.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Parts A, B, and D - Incidence of Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability]
Parts A, and D - Dose Limiting Toxicity (DLT)
Secondary study objectives
Part C - Overall survival (OS)
Parts A, B, C, and D - Duration of Objective Response (DOR)
Parts A, B, C, and D - Progression-Free Survival (PFS)
+5 moreOther study objectives
Part C - Area under the plasma concentration versus time curve (AUC) for PRO1184
Part C - Peak Plasma Concentration (Cmax) for PRO1184
Parts A and B - Overall survival
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
4Treatment groups
Experimental Treatment
Group I: Part D3Experimental Treatment1 Intervention
PRO1184 in combination with pembrolizumab
Group II: Part D2Experimental Treatment1 Intervention
PRO1184 in combination with bevacizumab
Group III: Part D1Experimental Treatment1 Intervention
PRO1184 in combination with carboplatin
Group IV: Part A, B, CExperimental Treatment1 Intervention
PRO1184 monotherapy in escalating doses in Part A and at the recommended dose in Part B and C.
Find a Location
Who is running the clinical trial?
GenmabLead Sponsor
71 Previous Clinical Trials
14,448 Total Patients Enrolled
ProfoundBio US Co.Lead Sponsor
2 Previous Clinical Trials
348 Total Patients Enrolled
Study OfficialStudy DirectorGenmab
19 Previous Clinical Trials
5,947 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had any other cancer in the last 3 years.I do not have active brain metastases, but treated and stable ones are okay.I have not had a severe infection in the last 2 weeks.My cancer is confirmed and cannot be removed by surgery.I have received treatments known to help my condition.My tumor shows folate receptor alpha expression.You have a specific amount of measurable disease for most tumors, but for pleural mesothelioma, a different method will be used to measure the disease.My blood, liver, kidney, and heart are functioning well.I am fully active or can carry out light work.You are willing to give a sample of your tumor for testing.I haven't taken strong P450 CYP3A inhibitors in the last 14 days.You have tested positive for hepatitis B, hepatitis C, or HIV.
Research Study Groups:
This trial has the following groups:- Group 1: Part D1
- Group 2: Part D2
- Group 3: Part A, B, C
- Group 4: Part D3
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.