PRO1184 for Advanced Solid Tumors
About the study
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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion Criteria:
- 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
- previously received therapies known to confer clinical benefit
- willing to provide a tumor sample (archive tissue or fresh biopsy)
- ECOG performance status 0 or 1
- measurable disease per RECIST v1.1 for all tumor types other than pleural mesothelioma which will use mRECIST v1.1 at baseline
- adequate hematologic, hepatic, renal and cardiac function
- for Part B, evidence of folate receptor alpha expression in tumor cells
EXCLUSION CRITERIA
Exclusion Criteria:
- other malignancy within 3 years
- active CNS metastases (treated, stable CNS metastases are allowed)
- uncontrolled Grade 3 or greater infection within 2 weeks
- positive for HBV, HCV or HIV
- use of a strong P450 CYP3A inhibitor within 14 days (dose escalation only)
additional protocol defined inclusion/exclusion criteria may apply
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Ovarian Cancer,Primary Peritoneal Carcinoma,Fallopian Tube Cancer,Endometrial Cancer,Non-small Cell Lung Cancer,Mesothelioma,Triple Negative Breast Cancer,HER2-negative Breast Cancer,Hormone Receptor-positive Breast Cancer
Age (in years)
18+
Phase
Phase 1/Phase 2
Participants needed
134
Est. Completion Date
Sep 30, 2025
Treatment type
Interventional
Sponsor
ProfoundBio US Co.
ClinicalTrials.gov identifier
NCT05579366
Study number
PRO1184-001
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